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1 [Insert Lecture Name Here]
Provider Education and Training to Increase Use of Intrauterine Contraception Association of Reproductive Health Professionals This slide should be shown at each presentation. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC).

2 Acknowledgment This program was made possible through educational grants from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals. Talking Points This program was made possible through educational grants from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Slide 2

3 Disclosure Declarations
Women with Multiple Sclerosis Disclosure Declarations Name Disclosure Barbara Clark, MPAS, PA-C (Planner) Nothing to disclose. Linda Dominguez, RN-C, NP (Planner) Linda Dominguez is a consultant and speaker for Teva , Bayer, and Merck. Mark Hathaway, MD, MPH (Planner) Mark Hathaway is a trainer/speaker for Merck. Carole Chrvala, PhD (Medical Writer) Aleya Horn Kennedy, MPP (Planner) Beth Jordan Mynett, MD (Planner) Amy Swann, MA Talking Points This presentation has been peer reviewed. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC).

4 [Insert Lecture Name Here]
Learning Objectives Explain the differences between the three forms of intrauterine contraception available in the United States Select appropriate candidates for intrauterine contraception Describe two possible side effects of each type of intrauterine contraceptive Talking Points At the conclusion of this session, participants should be able to: Explain the differences between the three forms of intrauterine contraception available in the United States Select appropriate candidates for intrauterine contraception Describe two possible side effects of each type of intrauterine contraceptive --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). more…

5 Learning Objectives (continued)
[Insert Lecture Name Here] Learning Objectives (continued) Describe pain management strategies during and after insertion Discuss strategies for follow-up of intrauterine contraceptive users Develop skills required for proper insertion techniques for the three methods of intrauterine contraception Talking Points At the conclusion of this session, participants should be able to: Describe pain management strategies during and after insertion of intrauterine contraception Discuss strategies for follow-up of intrauterine contraceptive users Develop skills required for proper insertion techniques for the three methods of intrauterine contraception --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC).

6 Terms for Intrauterine Contraception
IUC IUD IUS Talking Points There are many terms we use when referring to intrauterine contraception (IUC). ParaGard® is referred to as an intrauterine device (IUD). Mirena® (levonorgestrel [LNG] 52 IUS) and SkylaTM (LNG 13.5 IUS ) are referred to as an intrauterine system (IUS). The terms “IUD” and “IUS” mean the same thing.  Throughout this presentation, the abbreviations “IUC” and “IUD” refer to both the Copper T IUD and the LNG-releasing IUS, unless one or the other is specified. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC).

7 Unintended Pregnancy in the US
[Insert Lecture Name Here] Unintended Pregnancy in the US 6.8 million pregnancies over one year Intended: 51% Unintended: 49% Unintended births 23% 51% 21% 5% Talking Points The data on this slide are from the National Survey of Family Growth in 2006, the most recent year for which data are available. The National Survey of Family Growth is a series of nationally representative surveys that collect detailed reproductive information from women of reproductive age. They are conducted every few years by the National Center for Health Statistics of the Centers for Disease Control and Prevention (CDC). Unintended pregnancy continues to be a major public health issue in the United States. Nearly half (49%) of pregnancies in 2006 were unintended, up slightly from 2001 (48%). Of the total 6.8 million pregnancies in the United States in 2006, 1.1 million ended in fetal losses 1.4 million ended in abortions 4.3 million resulted in live births Of the 3.2 million (49%) unintended pregnancies in the United States in 2006, 1.6 million resulted in live births 0.2 million ended in fetal losses These unintended pregnancies accounted for 23% of births, 21% of abortions, and 5% fetal losses. About half (48%) of the women who had an unplanned birth had been using a contraceptive method during the month they became pregnant as had about 60% of those who had abortions. Of the 3.5 million (51%) intended pregnancies, 2.6 million resulted in live births The overall pregnancy rate for women ages was 108 per 1,000 women in 2006, and the unintended pregnancy rate was 52 per 1,000 women. 0.9 million resulted in miscarriages The highest pregnancy rates occurred among women ages 20-24, those who are socioeconomically disadvantaged, cohabiting women, and racial/ethnic minority groups, particularly blacks. The survey concluded that about half of unintended pregnancies that occur annually are among women who do not use effective contraception. However, half are among women who had been using contraception during the month they conceived. Therefore, it important to improve correct use of user-dependent methods and to encourage more use of long-acting, user-independent methods. (Finer LB, et al. Fertil Steril ) The gap is contraceptive use. References Finer LB, Zolna MR. Unintended pregnancy in the United States: incidence and disparities, Contraception. 2011; 84(5): Finer LB, Jerman J, Kavanaugh ML. Changes in use of long-acting contraceptive methods in the US, Fertil Steril (4):893-7. Finer LB, Henshaw SK. Disparities in rates of unintended pregnancy in the United States, 1994 and Perspect Sex Reprod Health. 2006;38:90-6. Henshaw SK. Unintended pregnancy in the United States. Fam Plann Perspect. 1998;30(1):24-9, 46. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Elective abortions Fetal losses Finer LB. Contraception. 2011; Finer LB. Fertil Steril. 2012; Finer LB. Perspect Sex Reprod Health. 2006; Henshaw SK. Fam Plann Perspect

8 [Insert Lecture Name Here]
Presentation Outline Contraceptive Use Globally and in the United States Overview of Current IUC Methods Patient Screening and Counseling for IUC Case presentations IUC Insertion and Management Hands-on Practicum Talking Points This presentation is grouped into the following chapters and sections: Contraceptive Use Globally and in the United States Overview of Current IUC Methods Patient Screening and Counseling for IUC Case presentations IUC Insertion and Management Hands-On Practicum --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC).

9 Contraceptive Use Globally and in the United States
[Insert Lecture Name Here] Contraceptive Use Globally and in the United States Chapter 1: Contraceptive Use Globally and in the United States --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC).

10 [Insert Lecture Name Here]
Worldwide Use of IUC Use for Married Women of Reproductive Age % Using IUCs Talking Points IUC is the most popular form of reversible contraception used worldwide. The population listed here—women ages who are currently married or in a union and using family planning—is the population that is most suited for IUC use, but only a very small percentage of women in North America use IUC. Today, the rate of IUC use in the United States among women ages who are currently married or in a union and using family planning is 5.3%, rather than 1%. Still, among all contraceptives in the United States, IUC is used far less often than sterilization. The opposite is true in other countries. References Population Reference Bureau. Family Planning Worldwide Data Sheet Mosher WD, Jones J. Use of contraception in the United States:  Vital Health Stat Series 23, No. 29. Available at Retrieved April 15, 2013. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Asia Europe Latin America & Caribbean Africa Oceania North America Population Reference Bureau. 2002; Mosher WD. Vital Health Stat

11 History of Successful IUC Use
[Insert Lecture Name Here] History of Successful IUC Use 1909: Grafenberg develops ring-shaped IUC device 1967: T-shaped device developed 1976: Copper T 200 becomes first copper IUD 1988: Copper T 380 IUD available in the United States 2013: LNG 13.5 IUS available in the United States 1968: Contraceptive action of intrauterine copper reported 1962: First international conference on IUC; designs for plastic spiral and plastic loop presented 1980: LNG IUC tested in randomized clinical trials 2001: LNG 52 IUS available in the United States Talking Points The first version of the modern intrauterine contraceptive was developed in 1909 by a German gynecologist and sex researcher named Ernst Grafenberg. It was a ring-shaped device made of silver wire and silkworm gut. It wasn’t widely used until the 1920s. Plastics became widely available in the 1950s and were very useful in the development of new forms of IUC. A flurry of activity at The Population Council resulted in the First International Conference on Intrauterine Contraception in 1962, where Drs. Marguiles and Lippes introduced the intrauterine plastic spiral and intrauterine plastic loop. In 1964, Bernard Berelson, vice president of The Population Council, at the Second International Conference stated, “This simple device can and will change the history of the world.” In 1967, a scientist at The Population Council developed a T-shaped device. Since 1960, nine intrauterine contraceptives have appeared on the US market. In 1968, the contraceptive action of intrauterine copper was reported. In 1976, the Copper T 200 became the first copper-based IUD. The Population Council worked with FEI Women’s Healthcare LLC to refine the design to increase its contraceptive duration and effectiveness. This research resulted in the Copper T 380A, which has copper collars on the arms and copper wire coiled around the stem. In 1980, the LNG-releasing IUD (commonly referred to as an intrauterine system, or IUS) was tested in randomized clinical trials. The Copper T IUD, under the brand name ParaGard®, was approved by the Food and Drug Administration (FDA) in 1984 and has been available for use in the United States since 1988. ParaGard®, originally marketed by Duramed Pharmaceuticals, Inc., a division of Barr Pharmaceuticals, Inc., is currently marketed by Teva Pharmaceuticals. In 2000, the LNG-releasing IUS, or LNG 52 IUS, under the brand name Mirena®, became available in the United States. It was originally marketed by Berlex, Inc., but is now marketed by Bayer HealthCare Pharmaceuticals, Inc. In 2013, the LNG 13.5 IUS, under the brand name SkylaTM, became available in the United States. It is marketed by Bayer HealthCare Pharmaceuticals. References Richter R. Ein mittel zur verhuntung der Konception. Deutsche Med Wochenschr. 1909;35: Grafenberg E. Die intrauterine Methode der Konzeption Verhütung. Proceedings of the Third Congress of the World League for Sexual Reform; London, UK. Heinemann; 1930. Ishihama A. Clinical studies on intrauterine rings. Yokohama Med Bull.1959;10: Oppenheimer W. Prevention of pregnancy by the Grafenberg ring method. Am J Obstet Gynecol. 1959;78: Berelson B. Intrauterine contraception: Proceedings of the Second International Conference. Amsterdam: Excerpta Medica Foundation; 1964:13. Marguiles LC. Permanent reversible contraception with an intrauterine plastic spiral. Proceedings of the Conference on Intrauterine Contraceptive Devices. Amsterdam: Excerpta Medica Foundation; 1962:61-8. Lippes J. A study of intrauterine contraception: development of a plastic loop. Proceedings of the Conference on Intrauterine Contraceptive Devices. Amsterdam: Excerpta Medica Foundation; 1962:68-75. Hubacher D, Cheng D. Intrauterine devices and reproductive health: American women in feast and famine. Contraception. 2004;69: Lee NC. Type of intrauterine device and the risk of pelvic inflammatory disease. Obstet Gynecol. 1983;62:1-6. Mosher WD, Martinez GM, Chandra A, et al. Use of contraception and use of family planning services in the United States: In CDC: Advance Data from Vital and Health Statistics. No. 350, 2004. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Richter R. Deutsche Med Wochenschr. 1909; Grafenberg E. 1930; Ishihama A. Yokohama Med Bull. 1959; Oppenheimer W. Am J Obstet Gynecol. 1959; Berelson B. 1964; Marguiles LC. 1962; Lippes J. 1962; Hubacher D. Contraception. 2004; Lee NC. Obstet Gynecol. 1983; Mosher WD

12 Need for Effective Reversible Methods
Environmental Impacts on Reproductive Health: Foundations of the Science Need for Effective Reversible Methods There is a need for effective contraceptive methods that are “forgettable” 1 in 5 20% pregnancies ends in abortion of women selecting sterilization at age 30 years or younger express regret later Talking Points The rate of unintended pregnancy and the regret expressed by women selecting sterilization at a young age point to the need for effective contraceptive methods that are “forgettable” (i.e., require no action for maintenance) and reversible. The US abortion rate declined by 5% between 1996 and 2000, reaching the lowest rate since The number of abortion providers also declined. With more than one in five US pregnancies ending in abortion, women are becoming pregnant more often than they desire. These are, by definition, unintended pregnancies that could have been prevented by effective contraception. The rate of unintended pregnancy in the United States is higher than in many Western European countries but is within the range of a few other developed countries, such as Sweden and Australia. Many women who select sterilization at a young age later express regret. Many of these women choose sterilization because they don’t know that equally effective reversible options exist. References Finer LB, Henshaw SK. Abortion incidence and services in the United States in Perspect Sex Reprod Health. 2003;35(1):6-15. Stanwood, NL, Garrett JM, Konrad TR. Obstetrician-gynecologists and the intrauterine device: a survey of attitudes and practice. Obstet Gynecol. 2002(2);99: Hillis SD, Marchbanks PA, Tylor LR, Peterson HB. Poststerilization regret: findings from the United States Collaborative Review of Sterilization. Obstet Gynecol. 1999;93(6):889. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Finer LB. Perspect Sexual Reprod Health. 2003; Stanwood NL. Obstet Gynecol. 2002; Hillis SD. Obstet Gynecol

13 [Insert Lecture Name Here]
Why an Update on IUC? Myths exist about IUC Selection of candidates is unduly restrictive Misinformation about IUC among providers and patients is common Talking Points Myths exist about IUC: Many believe that IUC is not safe. Many believe that IUC is not appropriate for nulliparous women. Many believe that IUC cannot be used in women who have had an ectopic pregnancy. According to the results of a survey of consumer and provider Web sites, many sites carry inaccurate or outdated information about IUC: One-half of the sites surveyed depict IUC as increasing the risk of pelvic inflammatory disease (PID) (not just in the first few weeks). Two-thirds of the sites say that IUC heightens the risk for ectopic pregnancy. One-quarter of the sites portray the use of IUC as increasing the risk of infertility. References Stanwood NL, Garrett JM, Konrad TR. Obstetrician-gynecologists and the intrauterine device: a survey of attitudes and practice. Obstet Gynecol. 2002;99(2): Weiss E, Moore K. An assessment of the quality of information available on the Internet about the IUD and the potential impact on contraceptive choices. Contraception. 2003;68(5): --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Stanwood NL. Obstet Gynecol. 2002; Weiss E. Contraception

14 Why IUC Is Underused in the United States
[Insert Lecture Name Here] Why IUC Is Underused in the United States Lack of awareness of method among women Myths about IUC safety Negative publicity Misconceptions Upfront cost Lack of positive marketing Fear of litigation Talking Points Reasons for the underuse of IUC in the United States include: Lack of awareness of method among women Myths about IUC safety Negative publicity about older methods Misconceptions among providers and public Upfront cost for patient and provider Lack of positive marketing Fear of litigation A mailed survey of 811 practicing obstetrician–gynecologists (ob/gyns) (all of whom were fellows of the American College of Obstetricians and Gynecologists) shows that ob/gyns insert few IUDs because of fear of litigation and myths about IUC safety. References Stanwood, NL, Garrett JM, Konrad TR. Obstetrician-gynecologists and the intrauterine device: a survey of attitudes and practice. Obstet Gynecol. 2002;99(2): Steinauer JE, DePineres T, Robert AM, et al. Training family practice residents in abortion and other reproductive health care: a nationwide survey. Fam Plann Perspect. 1997;29(5):222-7. Weir E. Preventing pregnancy: a fresh look at the IUD. CMAJ. 2003;169(6):585. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Stanwood NL. Obstet Gynecol. 2002; Steinauer JE. Fam Plann Perspect. 1997; Weir E. CMAJ

15 Use of IUC by Female Ob/Gyns vs. All Women in the United States
[Insert Lecture Name Here] Use of IUC by Female Ob/Gyns vs. All Women in the United States % Using IUC Talking Points This slide shows the percentage of female ob/gyns (18%) who, when surveyed, said they would choose IUC as their method of contraception if they needed birth control, compared with the use of IUC in the general population (0.7%). The women physicians were ACOG fellows (N = 301). Despite the low use of IUC among US women, those who use IUC are highly satisfied with the method. Almost all—99%—say they are “very satisfied” or “somewhat satisfied” with IUC use (Forrest JD). References Population Reference Bureau. Family Planning Worldwide 2002 Data Sheet The Gallup Organization. A survey of female ob-gyns on health issues and concerns. Conducted for the American College of Obstetricians and Gynecologists. Princeton, NJ. December Key findings reviewed in: ACOG Today. 2004;48:1, 6-7. Forrest JD. US women’s perceptions of and attitudes about the IUD. Obstet Gynecol Surv. 1996;51(12 Suppl):S30-4. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Female Ob/Gyn Physicians General Population Population Reference Bureau. 2002; The Gallup Organization

16 Considerations in Choice of Contraceptive Methods
[Insert Lecture Name Here] Considerations in Choice of Contraceptive Methods Effectiveness Side effects Convenience Duration of action and childbearing plans Patient choice Reversibility Non-contraceptive benefits Cost Privacy Talking Points This slide presents considerations in choice of contraceptive methods. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC).

17 Overview of Current IUC Methods
[Insert Lecture Name Here] Overview of Current IUC Methods Chapter 2: Overview of Current IUC Methods --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC).

18 Characteristics of IUC
[Insert Lecture Name Here] Characteristics of IUC Highest patient satisfaction among methods Rapid return of fertility Safe Immediately effective Long-term protection Highly effective Talking Points Highest patient satisfaction among methods: Patients who use IUC are most satisfied with their method compared with patients using other methods. IUC use allows spontaneity. Rapid return of fertility: Patients who use IUC have a rapid return of fertility after removal of the device. Safety: IUC is safe. Complications are rare. Immediately effective: IUC protects against pregnancy immediately after insertion of the device. Long-term protection: IUC can be used for 5–10 years. Highly effective: The efficacy of IUC is comparable to that of sterilization. References Fortney JA, Feldblum PJ, Raymond EG. Intrauterine devices: the optimal long-term contraceptive method? J Reprod Med. 1999;44(3): Belhadj H, Sivin I, Diaz S, et al. Recovery of fertility after use of the levonorgestrel 20 mcg/d or copper T 380 Ag intrauterine device. Contraception. 1986;34(3):261-7. Skjeldestad F, Bratt H. Fertility after complicated and non-complicated use of IUDs. A controlled prospective study. Adv Contracept. 1988;4(3): Arumugam K, Tai FM. Return of fertility after long-term use of the intrauterine device. Med Sci Res. 1991;19(6):183. Tadesse E, Adane M, Abiyou M. Caesarean section deliveries at Tikur Anbessa Teaching Hospital, Ethiopia. East Afr Med J. 1996;73(9): --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Fortney JA. J Reprod Med. 1999; Belhadj H. Contraception. 1986; Skjeldestad F. Adv Contracept. 1988; Arumugam K. Med Sci Res. 1991; Tadesse E. East Afr Med J

19 Dispelling Myths About IUC
In fact, IUDs: Are not abortifacients Do not cause ectopic pregnancies Do not cause pelvic infection Do not decrease the likelihood of future pregnancies Are not large in size Can be used by nulliparous women Can be used by women who have had an ectopic pregnancy Do not need to be removed for PID treatment Do not have to be removed if inflammatory changes are noted on a Pap test Talking Points IUDs are not abortifacients; they prevent fertilization. IUC does not increase the risk of ectopic pregnancy; rather, it decreases the risk of both ectopic and intrauterine pregnancy. However, IUC is more efficient at preventing uterine than ectopic pregnancy, so that compared with other methods, a higher fraction of pregnancies that occur with IUC are ectopic. A survey of ob/gyns shows that, although attitudes toward the safety and effectiveness of IUC are very positive, most respondents believe that a long-term causal relationship exists between the modern Copper T IUD and PID. The truth is that IUC use, in properly selected patients, does not increase the risk of PID. Untreated pelvic infection is the most common cause of infertility; IUC use is not associated with infertility. The 2001 New England Journal of Medicine article by Hubacher et al., as well as other studies, confirm the overall benign impact on women who use Copper T IUDs. Some women are hesitant to use IUC because they perceive the devices to be larger than they actually are. In truth, both types of IUC devices are small and can fit in the palm of the hand. A 4-year study found that IUC failure and expulsion rates were lower for nulliparous than parous women. Another study that evaluated three types of IUC in nulliparous women found low failure and expulsion rates. According to the World Health Organization’s “Medical Eligibility Criteria for Contraceptive Use,” nulliparity is considered a condition for which the advantages of using IUC generally outweigh the theoretical or proven risks. IUC use in women with a previous ectopic pregnancy is appropriate but reflects off-label use. IUC users who develop an STI or PID should be tested for relevant infections and treated with appropriate antibiotic therapy. Clinical guidelines state that removal of the IUD is not necessary unless symptoms fail to improve within 72 hours of the start of treatment. An IUD does not have to be removed if inflammatory changes are noted on a Pap test. Actinomyces-like organisms (ALO) normally exist in the female genital tract and are sometimes identified on Pap tests. Current recommendations state that symptomatic women with a finding of ALO from a Pap or other test should be treated with appropriate antibiotics and the IUD should be removed (after the patient has begun antibiotics). Asymptomatic women require neither IUD removal nor antibiotic therapy. References Duenas JL, Albert A, Carrasco F. Intrauterine contraception in nulligravid vs. parous women. Contraception. 1996;53(1):23-4. Forrest JD. U.S. women’s perceptions of and attitudes about the IUD. Obstet Gynecol Surv. 1996;51(12 Suppl):S30-4. Hubacher D, Lara-Ricalde R, Taylor D. Use of copper intrauterine devices and the risk of tubal infertility among nulligravid women. N Engl J Med. 2001;345(8):561-7. Lippes J. Pelvic actinomycosis: a review and preliminary look at prevalence. Am J Obstet Gynecol. 1999;180(2 Pt 1):265-9. Otero-Flores JB, Guerrero-Carreno FJ, Vazquez-Estrada LA. A comparative randomized study of three different IUDs in nulliparous Mexican women. Contraception. 2003;67(4):273-6. Penney G, Brechin S, de Souza A, et al. The copper intrauterine device as long-term contraception. J Fam Plann Reprod Health Care. 2004;30(1):29-41. Stanwood NL, Garrett JM, Konrad TR. Obstetrician-gynecologists and the intrauterine device: a survey of attitudes and practice. Obstet Gynecol. 2002(2);99: World Health Organization (WHO). Medical Eligibility Criteria for Contraceptive Use. 4th ed. Geneva: WHO; 2009. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Duenas JL. Contraception. 1996; Forrest JD. Obstet Gynecol Surv. 1996; Hubacher D. N Engl J Med. 2001; Lippes J. Am J Obstet Gynecol. 1999; Otero-Flores JB. Contraception. 2003; Penney G. J Fam Plann Reprod Health Care. 2004; Stanwood NL. Obstet Gynecol. 2002; WHO

20 IUC Available in the United States
[Insert Lecture Name Here] IUC Available in the United States Copper T 380A IUD Copper ions Approved for 10 years of use Talking Points Copper T 380A IUD: Currently marketed as ParaGard® by Teva Women’s Health, Inc., a subsidiary of Teva Pharmaceuticals, Inc. T-shaped polyethylene and copper unit The device has a horizontal length of 36 mm and a vertical length of 36 mm. The inserter for the Copper T 380A IUD is mm in diameter. Approved for up to 10 years of use; data demonstrate 12-year efficacy Approved by the FDA in 1984; marketed in 1988 References ParaGard® Prescribing Information. Sellersville, PA: Teva Women’s Health, Inc., a subsidiary of Teva Pharmaceuticals, Inc. Available at Retrieved April 15, 2013. Teva US Medical Information. ParaGard Insertion Tube Specifications --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). more… ParaGard® PI. 2013; Teva

21 IUC Available in the United States (continued)
[Insert Lecture Name Here] IUC Available in the United States (continued) LNG 52 IUS Releases 20 μg of LNG per day Approved for 5 years of use LNG 13.5 IUS Releases 14 μg of LNG per day Approved for 3 years of use Talking Points LNG 52 IUS: Approved for up to 5 years of use; data demonstrate 7-year efficacy Currently marketed as Mirena® by Bayer HealthCare Pharmaceuticals, Inc. Approved by the FDA in 2000; used in Europe since 1990 Contains 52 mg of LNG, released at a rate of about 20 μg/day, decreasing to half that amount over its recommended life LNG 13.5 IUS (referred to in some literature as “LCS 12”): Horizontal length = 32 mm; vertical length = 32 mm Currently marketed as SkylaTM by Bayer HealthCare Pharmaceuticals, Inc. Smaller size and lower dose than Mirena®, aimed at greater acceptability among younger, nulliparous women Nulliparous women may have smaller uterine cavities and tighter cervical os than their parous counterparts. Therefore a smaller frame may be better suited for nulliparous women. In addition, a lower systemic exposure to LNG might lead to a better side effect profile. Contains 13.5 mg of LNG, released at a rate of approximately 14 μg/day after 24 days and declining to 5 μg/day after 3 years Horizontal length = 28 mm; vertical length = 30 mm. Silver ring helps to distinguish it from the LNG 52 IUS (Mirena®) on X-ray or ultrasound. Approved for up to 3 years of use Approved by the FDA in 2013 Differences in inserters: The SkylaTM inserter is smaller than the Mirena® inserter. The SkylaTM insertion tube is 3.8 mm in diameter; the Mirena® insertion tube is 4.75 mm in diameter. The two types of inserters function similarly, except that, once the SkylaTM inserter is released, it cannot be reloaded into the inserter tube, whereas the Mirena® inserter can be reloaded. References Mirena® Prescribing Information. Wayne, NJ: Bayer HealthCare Pharmaceuticals. Available at Retrieved April 15, 2013. SkylaTM Prescribing Information. Wayne, NJ: Bayer HealthCare Pharmaceuticals. Available at Retrieved April 15, 2013. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Mirena® PI. 2013; SkylaTM PI

22 IUC Mechanism of Action
Copper T IUD LNG 52 IUS LNG 13.5 IUS Primary Prevents fertilization Reduces sperm motility and viability Inhibits development of ova Inhibits fertilization Causes cervical mucus to thicken Inhibits sperm motility and function Secondary Inhibits implantation Talking Points The exact mechanism of action of the copper IUD is not clear; however, substantial evidence suggests that the primary mechanism of action is prevention of fertilization. Inhibition of implantation would explain the high effectiveness of copper IUDs to act as emergency contraception. The mechanism of action of the LNG IUS (LNG 52 IUS [Mirena®] and LNG 13.5 IUS [SkylaTM]) is similar to that of LNG implants or LNG-containing minipills. The primary mechanisms of action are thickening of the cervical mucus and inhibition of sperm motility and function. The endometrial atrophy that is a consequence of the high endometrial levels of LNG leads to a substantial decrease in menstrual flow and absence of bleeding in some women who use this form of IUC. It is important to some patients that the LNG IUS mechanisms of action all occur before conception. The LNG IUS devices prevent fertilization rather than disrupt implantation (a common misconception). The low ectopic pregnancy rate relative to pregnancy rate suggests that an anti-implantation effect is not the primary contraceptive mechanism of action of the LNG IUS devices. References Ortiz ME, Croxatto HB. Copper-T intrauterine device and levonorgestrel intrauterine system: biological bases of their mechanism of action. Contraception. 2007;75(6 Suppl):S16-30. Alvarez F, Brache V, Fernandez E, et al. New insights on the mode of action of intrauterine contraceptive devices in women. Fertil Steril. 1988;49: Segal SJ, Alvarez-Sanchez F, Adejuwon CA, et al. Absence of chorionic gonadotropin in sera of women who use intrauterine devices. Fertil Steril. 1985;44:214-8. American College of Obstetricians and Gynecologists. Statement on Contraceptive Methods. Washington, DC: ACOG; 1998. Jonsson B, Landgren B-M, Eneroth P. Effects of various IUDs on the composition of cervical mucus. Contraception. 1991;43: Silverberg SG, Haukkamaa M, Arko H, et al. Endometrial morphology during long-term use of levonorgestrel-releasing intrauterine devices. Int J Gynecol Pathol. 1986;5(3): --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Ortiz ME. Contraception. 2007; Alvarez F. Fertil Steril. 1988; Segal SJ. Fertil Steril. 1985; ACOG. 1998; Jonsson B. Contraception. 1991; Silverberg SG. Int J Gynecol Pathol

23 [Insert Lecture Name Here]
Efficacy: First-Year Failure Rates of Selected Contraceptives (Typical Use) LNG IUS Sterilization—female Copper T IUD Injectable (DMPA) Pills/patch/ring Condom—male Talking Points First-year failure rates of reversible contraceptive methods and of no contraceptive use are indicated in the chart. For the LNG IUS, perfect use = typical use. The LNG 52 IUS (Mirena®) had a failure rate of 0.2%; the LNG 13.5 IUS (SkylaTM), 0.4%. For the Copper T IUD, perfect use has a slightly lower failure rate of 0.6%. In addition, because the failure rate for IUC is comparable to that for sterilization, IUC could be viewed in this context as reversible sterilization, not just reversible contraception. References Trussell J. Contraceptive efficacy. In: Hatcher RA, Trussell J, Nelson AL, et al., eds. Contraceptive Technology. 20th revised ed. New York: Ardent Media; 2011. World Health Organization. Mechanism of Action, Safety, and Efficacy of Intrauterine Devices. Technical Report Series 753. Geneva: WHO; 1987. Peterson HB, Xia Z, Hughes JM, et al. The risk of pregnancy after tubal sterilization: findings from the U.S. Collaborative Review of Sterilization. Am J Obstet Gynecol. 1996;174(4):1161-8; discussion, --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Spermicides No contraception Percent Trussell J. 2011; WHO. 1987; Peterson HB. Am J Obstet Gynecol

24 Return to Fertility (Reversibility)
[Insert Lecture Name Here] Return to Fertility (Reversibility) Pregnancies (%) Months After Discontinuation 20 40 60 80 100 12 18 24 30 36 42 IUC OC Diaphragm Other methods Talking Points Research indicates fertility rapidly returns after IUD removal, similar to after the discontinuation of barrier methods. References Vessey MP, Lawless M, McPherson K, Yeates D. Fertility after stopping use of intrauterine contraceptive device. Br Med J (Clin Res Ed). 1983;286(6359):106. Andersson K, Batar I, Rybo G. Return to fertility after removal of a levonorgestrel releasing intrauterine device and Nova-T. Contraception. 1992;46:575. Belhadj H, Sivin I, Diaz S, et al. Recovery of fertility after use of the levonorgestrel 20 mcg/d or copper T 380 Ag intrauterine device. Contraception. 1986;34(3):261. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Vessey MP. Br Med J. 1983; Andersson K. Contraception. 1992; Belhadj H. Contraception

25 Continuation Rates at 1 Year
84% of Copper T IUD users 55% Non-LARC* users 88% of LNG 52 IUS users VS. Talking Points In the Contraceptive CHOICE Project study, 9,256 women ages were counseled about all methods of contraception. After receiving counseling, 75% of women selected a long-acting reversible contraception (LARC) method (IUC or implant). More than 40% of women ages chose IUC. Among the women who selected IUC, 84% who chose the Copper T IUD and 88% who selected the LNG 52 IUS (Mirena®) were still using the method at 1 year. In contrast, only 55% of women who chose a non-LARC method (contraceptive pill, patch, or ring) were still using their chosen method at 1 year. When data from the first 5,087 participants enrolled in the Contraceptive CHOICE Project the study were analyzed, it was found that the most common reason for discontinuation of IUC was bleeding or cramping or both; 14% of all Copper T IUD users and 5% of all LNG 52 IUS users reported discontinuing the method for these reasons. In addition, a small percentage (3%) of LNG IUS users reported discontinuation of the method because of side effects such as acne and weight change. References Washington University School of Medicine in St. Louis: The Contraceptive Choice Project. Available from: Retrieved April 2013. Rosenstock JR, Peipert JF, Madden T, et al. Continuation of reversible contraception in teenagers and young women. Obstet Gynecol. 2012;120(6): Peipert JF, Zhao Q, Allsworth JE, et al. Continuation and satisfaction of reversible contraception. Obstet Gynecol. 2011;117(5): --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). *LARC = long-acting reversible contraception. Non-LARC methods include the contraceptive pill, patch, and ring. The Contraceptive Choice Project. 2013; Rosenstock JR. Obstet Gynecol. 2012; Peipert JF. Obstet Gynecol

26 Potential Side Effects
[Insert Lecture Name Here] Potential Side Effects Type During insertion First few days During insertion Copper T: Heavier or prolonged menses LNG IUS: Gradual decrease in menstrual flow Variable pain and/or cramping Vasovagal reactions Light bleeding Mild cramping Inter-menstrual cramping Cramping Talking Points The Copper T IUD may result in heavier or prolonged menses. During the first 3-6 months of LNG IUS use, bleeding may be irregular and the number of days with bleeding or spotting may be increased from baseline. Thereafter, bleeding generally decreases to the point that about 50% of users have amenorrhea at 12 months after insertion. In fact, the LNG IUS has been investigated for the treatment of menorrhagia. One clinical trial found that the LNG IUS was as effective as endometrial ablation at reducing blood loss when assessed 1 year after insertion. References Silverberg SG, Haukkamaa M, Arko H, et al. Endometrial morphology during long-term use of levonorgestrel-releasing intrauterine devices. Int J Gynecol Pathol. 1986;5(3): Sivin I, Stern J, Coutinho E, et al. Prolonged intrauterine contraception: a seven-year randomized study of the levonorgestrel 20 mcg/day (LNG 20) and the copper T380 Ag IUDs. Contraception. 1991;44(5): Hidalgo M, Bahamondes L, Perrotti M, et al. Bleeding patterns and clinical performance of the levonorgestrel-releasing intrauterine system (Mirena) up to two years. Contraception. 2002;65(2): Crosignani PG, Vercellini P, Mosconi P, et al. Levonorgestrel-releasing intrauterine device versus hysteroscopic endometrial resection in the treatment of dysfunctional uterine bleeding. Obstet Gynecol. 1997;90(2): --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Silverberg SG. Int J Gynecol Pathol. 1986; Sivin I. Contraception. 1991; Hidalgo M. Contraception. 2002; Crosignani PG. Obstet Gynecol

27 IUC Non-contraceptive Benefits
[Insert Lecture Name Here] IUC Non-contraceptive Benefits Protection against endometrial cancer Alternative to hysterectomy or endometrial ablation Treatment of heavy bleeding/ dysmenorrhea Copper T IUD LNG 52 IUS Talking Points Alternative to hysterectomy: 80% of women who used the LNG 52 IUS (Mirena®) cancelled surgery, compared with 9% of women who received normal care. Treatment of heavy bleeding: 97% decrease in menstrual blood loss Both the alternative to hysterectomy and treatment of heavy bleeding statements are based on data from the cited “before-after” studies. (Hurskainen R 2001; Hurskainen R 1996; Andersson JK 1990) The LNG 13.5 IUS (SkylaTM) is approved for contraception but at present does not have an FDA-approved indication for the treatment of heavy bleeding. References Andersson JK, Rybo G. Levonorgestrel-releasing intrauterine device in the treatment of menorrhagia. Br J Obstet Gynaecol. 1990;97(8):690-4. Hurskainen R, Teperi J, Rissanen P, et al. Quality of life and cost-effectiveness of levonorgestrel-releasing intrauterine system versus hysterectomy for treatment of menorrhagia: a randomised trial. Lancet. 2001;357(9252):273-7. Hurskainen R, Teperi J, Rissanen P, et al. Clinical outcomes and costs with the levonorgestrel-releasing intrauterine system or hysterectomy for treatment of menorrhagia: randomized trial 5-year follow-up. JAMA. 2004;291(12): Hill DA, Weiss NS, Voigt LF, Beresford SA. Endometrial cancer in relation to intra-uterine device use. Int J Cancer. 1997;70(3): Rosenblatt KA, Thomas DB. Intrauterine devices and endometrial cancer. The WHO Collaborative Study of Neoplasia and Steroid Contraceptives. Contraception. 1996;54(6): SkylaTM Prescribing Information. Wayne, NJ: Bayer HealthCare Pharmaceuticals. Available at Retrieved April 15, 2013. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Andersson JK. Br J Obstet Gynaecol. 1990; Hurskainen R, et al. Lancet. 2001; Hurskainen R. JAMA. 2004; Hill DA. Int J Cancer. 1997; Rosenblatt KA. Contraception. 1996; Skyla™ PI

28 LNG 52 IUS Non-contraceptive Uses
[Insert Lecture Name Here] LNG 52 IUS Non-contraceptive Uses Good evidence: Heavy menstrual bleeding* Dysmenorrhea and pain Endometrial protection during hormone or tamoxifen therapy in perimenopausal and postmenopausal women Talking Points An expanding roster of non-contraceptive benefits with the LNG 52 IUS (Mirena®) are becoming apparent. Good scientific evidence has emerged for its use to manage heavy bleeding and dysmenorrhea and menstrual pain and to protect the endometrium from overproliferation during hormone therapy or tamoxifen treatment in peri- and postmenopausal women. One trial found the LNG 52 IUS (Mirena®) to be as effective as transcervical endometrial resection for dysfunctional uterine bleeding. There is also limited evidence to suggest that the LNG 52 IUS (Mirena®) may be beneficial in women who have uterine fibroids, endometriosis, adenomyosis, or endometrial hyperplasia or cancer. Many women have concerns about the use of hormones and the risk of breast cancer. A 2005 Finnish postmarketing study of users of LNG-releasing IUDs (N = 17,360) offers reassurance that use of this form of IUC is not associated with an increased risk of breast cancer. The incidence rate per 100,000 woman-years among LNG 52 IUS (Mirena®) users ages was 120.3, while that among the average Finnish population in this age group was Similarly, the incidence rate per 100,000 woman-years among LNG 52 IUS (Mirena®) users ages was 203.6, while that among the average Finnish population in this age group was This trend was similar across younger and older age groups. References Varma R, Sinha D, Gupta JK. Non-contraceptive uses of levonorgestrel-releasing hormone system (LNG-IUS)—a systematic enquiry and overview. Eur J Obstet Gynecol Reprod Biol. 2006;125(1):9-28. Gupta B, Mittal S, Misra S, et al. Levonorgestrel-releasing intrauterine system vs. transcervical endometrial resection for dysfunctional uterine bleeding. Int J Gynecol Obstet. 2006;95(3):261-6. Backman T, Rauramo I, Jaakkola K, et al. Use of the levonorgestrel-releasing intrauterine system and breast cancer. Obstet Gynecol. 2005;106(4): --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). *FDA-approved indication. Varma R. Eur J Obstet Gynecol Reprod Biol. 2006; Gupta B. Int J Gynecol Obstet. 2006; Backman T. Obstet Gynecol

29 [Insert Lecture Name Here]
Costs for Patients Patient costs are a factor in choosing a contraceptive method. Up-front costs concern some women. The costs of side effects associated with some contraceptives are high compared with those for IUC. Public clinics and patient assistance programs offered by pharmaceutical companies can be explored for low-income or uninsured patients. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC).

30 [Insert Lecture Name Here]
Safety: Overview Recent data continue to demonstrate the safety of current methods of IUC. Talking Points Recent data continue to demonstrate the safety of current methods of IUC. References Hubacher D, Lara-Ricalde R, Taylor D. Use of copper intrauterine devices and the risk of tubal infertility among nulligravid women. NEJM. 2001;345(8):561-7. Nelson AL. The intrauterine contraceptive device. Obstet Gynecol Clin North Am. 2000;27(4): Meirik O, Farley TM, Sivin I. Safety and efficacy of levonorgestrel implant, intrauterine device, and sterilization. Obstet Gynecol. 2001;97(4): --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Hubacher D. N Engl J Med. 2001; Nelson AL. Obstet Gynecol Clin North Am. 2000; Meirik O. Obstet Gynecol

31 Safety: Medical Eligibility Criteria for Contraceptive Use
Category Risk Level 1 Method can be used without restriction. 2 Advantages generally outweigh theoretical or proven risks. 3 Method not usually recommended unless other, more appropriate methods are not available or not acceptable. 4 Method not to be used. Talking Points The World Health Organization (WHO) and CDC have developed criteria for medical eligibility for contraceptive use. Health care providers can use these categories when assessing the safety of contraceptive use for women and men with specific medical conditions or characteristics. Category 1: A condition for which there is no restriction for the use of the contraceptive method Category 2: A condition where the advantages of using the method generally outweigh the theoretical or proven risks Category 3: A condition in which the theoretical or proven risks usually outweigh the advantages of the method Category 4: A condition that represents an unacceptable health risk if the contraceptive method is used (i.e., contraindication). There are very few contraindications to the use of IUC. For complete information about relative contraindications, see the CDC criteria, available at or the WHO criteria, available at References Centers for Disease Control and Prevention. U.S. Medical Eligibility Criteria for Contraceptive Use, MMWR Recomm Rep. 2010;59(RR-4):52-63. World Health Organization. Medical Eligibility Criteria for Contraceptive Use. 4th ed. Geneva: WHO; 2009. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). CDC. MMWR Recomm Rep. 2010; WHO

32 Safety: Medical Eligibility Criteria for Contraceptive Use (continued)
Condition Qualifier for condition LNG IUS Copper T IUD Diabetes mellitus Past gestational diabetes 1 Diabetes without vascular disease 2 Diabetes with end-organ damage or >20 years’ duration Endometriosis Obesity BMI >30 kg/m2 Uterine fibroids IUC OK unless fibroids block insertion Talking Points IUC can be safely used in women with diabetes and obesity. Women with endometriosis can use IUC; however, active endometrial cancer and cervical cancer at the initiation of IUC use are contraindications (Category 4). If a woman develops endometrial cancer and cervical cancer while she is using IUC, it is a Category 2 and not a contraindication. Women with uterine fibroids can safely use IUC unless the fibroids block insertion. For complete information about relative contraindications, see the CDC criteria, available at or the WHO criteria, available at References Centers for Disease Control and Prevention. U.S. Medical Eligibility Criteria for Contraceptive Use, MMWR Recomm Rep. 2010;59(RR-4):52-63. World Health Organization. Medical Eligibility Criteria for Contraceptive Use. 4th ed. Geneva: WHO; 2009. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). CDC. MMWR Recomm Rep. 2010; WHO

33 Safety: Medical Eligibility Criteria for Contraceptive Use (continued)
Condition Qualifier for condition LNG IUS Copper T IUD Postpartum, not breastfeeding >3 weeks postpartum 1 Postpartum IUD insertion (breastfeeding or not breastfeeding) <10 minutes after placenta delivery 2 10 minutes after placenta delivery to 4 weeks postpartum >4 weeks postpartum Postpartum & breastfeeding >1 month postpartum Post-abortion First trimester Second trimester Talking Points Clinicians sometimes delay the insertion of an IUD until 12 weeks postpartum because of concerns that earlier insertion may lead to higher rates of expulsion and more complications. However, data now show that the Copper T IUD and LNG IUS (Mirena® and SkylaTM) may be inserted safely much sooner after delivery. The CDC guidelines are less restrictive than the WHO guidelines (Category 3) with regard to insertion of an IUD less than 10 minutes after delivery of the placenta after vaginal or cesarean delivery, regardless of whether the mother will be breastfeeding. For immediate post-placental insertion, the CDC guidelines assign the Copper T IUD to Category 1 and the LNG IUS devices (Mirena® and SkylaTM) to Category 2. IUDs can be inserted safely after abortion and are extremely effective. IUDs inserted after abortion are generally well tolerated; continuation and expulsion rates are comparable to those found in studies in which an IUD was inserted during or immediately after menses. IUD insertion immediately after abortion can greatly reduce the incidence of repeat abortion and unintended pregnancy. For complete information about relative contraindications, see the CDC criteria, available at or the WHO criteria, available at References Centers for Disease Control and Prevention. U.S. Medical Eligibility Criteria for Contraceptive Use, MMWR Recomm Rep. 2010;59(RR-4):52-63. Goodman S, Hendlish SK, Reeves MF, et al. Impact of immediate postabortal insertion of intrauterine contraception on repeat abortion. Contraception. 2008;78(2):143-8. Grimes DA, Lopez LM, Schulz KF, et al. Inserting an IUD right after abortion or miscarriage versus a later time. Cochrane Library. 2000;4:2. Available at: Retrieved August 16, 2013. Pakarinen P, Toivonen J, Luukkainen T. Randomized comparison of levonorgestrel- and copper-releasing intrauterine systems immediately after abortion, with 5 years' follow-up. Contraception. 2003;68(1):31-4. World Health Organization. Medical Eligibility Criteria for Contraceptive Use. 4th ed. Geneva: WHO; 2009. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). CDC. MMWR Recomm Rep. 2010; Goodman S. Contraception. 2008; Grimes DA. Cochrane Library. 2000; Pakarinen P. Contraception. 2003; WHO

34 Safety: Medical Eligibility Criteria for Contraceptive Use (continued)
Condition Qualifier for condition LNG IUS Copper T IUD HIV infection High risk or HIV+ 2 AIDS (without drug interactions) 3 PID Past, with subsequent pregnancy 1 Past, without subsequent pregnancy Current 4 STI Vaginitis/increased risk of STI Very high risk of STI Current gonorrhea, chlamydia, or purulent cervicitis Talking Points The WHO and CDC give both the Copper T IUD and LNG IUS a Category 2 medical eligibility rating, suggesting that, for women with HIV infection, the benefit of using an effective contraceptive method outweighs the potential risk of infection. Women with a history of PID can use IUC; however, active PID is a contraindication. Past infections are not a contraindication for IUC. For complete information about relative contraindications, see the CDC criteria, available at or the WHO criteria, available at References Centers for Disease Control and Prevention. US Medical Eligibility Criteria for Contraceptive Use. MMWR Recomm Rep. 2010;59(RR04):52-63. World Health Organization. Medical Eligibility Criteria for Contraceptive Use. 4th ed. Geneva: WHO; 2009. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). CDC. MMWR Recomm Rep. 2010; WHO

35 Safety: IUC Does Not Cause PID or Infertility
[Insert Lecture Name Here] Safety: IUC Does Not Cause PID or Infertility PID incidence among IUC users is similar to that among the general population Risk is increased only during the first month after insertion Preexisting STI at time of insertion, not IUC itself, increases risk Chlamydial infection, not use of IUC, is associated with increased risk of tubal occlusion Talking Points Longer duration of IUC use is associated with a lower rate of PID. The presence of a preexisting STI at the time of insertion, not IUC itself, increases the risk of PID. A review of the WHO's IUD clinical trial data found that, among approximately 20,000 women who used IUC for 21 days to 8 years, the incidence of PID was approximately 1 per 1,000 woman-years, compared with a rate of nearly 10 per 1,000 woman-years among women who used IUC for 20 days or less. In an open, randomized, comparative, multicenter Scandinavian trial by Andersson et al. (N = 2,758), women received either a Copper T IUD (Nova T) or LNG 52 IUS (Mirena®); 20 μg/24 h. No increase in the incidence of PID was seen in relation to IUD insertion. This may be due to protocol and training criteria, which included the requirement that cervicitis be excluded before insertion and aseptic technique be used at insertion. Previous studies of IUDs, many of which are no longer in use, suggested that copper IUDs might cause tubal infertility, decreasing the use of this method in nulligravid women. Hubacher et al. enrolled 1,895 women in a case-control study—358 women with primary infertility with tubal occlusion documented by hysterosalpingogram, 953 women who were infertile without tubal occlusion (infertile control subjects), and 584 primigravid women (pregnant control subjects). Information was obtained about the women’s past use of contraceptives, including copper IUDs; previous sexual relationships; and history of STIs. Each subject had antibody testing for Chlamydia trachomatis. Stratified analysis and logistic regression analyses were employed. Results: Odds ratio for tubal occlusion associated with previous use of a copper IUD was 1.0 (95% CI, ) when infertile women served as control subjects. When primigravid women served as control subjects, the odds ratio was 0.9 (95% CI, 0.5–1.6). The odds ratio for tubal occlusion associated with chlamydia was 2.4 (95% CI, 1.7–3.2). Conclusions: Previous use of a Copper T IUD is not associated with an increased risk of tubal occlusion among nulligravid women; rather, chlamydial infection is associated with this increased risk. These results have been confirmed by others: Hov GG, Skjeldestad FE, Hilstad T. Use of IUC and subsequent fertility: follow-up after participation in a randomized clinical trial. Contraception. 2007;75(2):88-92. Skjeldestad F, Bratt H. Fertility after complicated and non-complicated use of IUCs. A controlled prospective study. Adv Contracept. 1988;4(3): Wilson JC. A prospective New Zealand study of fertility after removal of copper intrauterine contraceptive devices for conception and because of complications: a four-year study. Am J Obstet Gynecol. 1989;160(2):391-6. References Sivin I, Stern J, Coutinho E, et al. Prolonged intrauterine contraception: a seven-year randomized study of the levonorgestrel 20 mcg/day (LNg 20) and the Copper T380 Ag IUDS. Contraception. 1991;44(5): Svensson L, Westrom L, Mardh PA. Contraceptives and acute salpingitis. JAMA. 1984;251(19): Farley TM, Rosenberg MJ, Rowe PJ, et al. Intrauterine devices and pelvic inflammatory disease: an international perspective. Lancet. 1992;339(8796):785-8. Andersson K, Odlind V, Rybo G. Levonorgestrel-releasing and copper-releasing (Nova T) IUDs during five years of use: a randomized comparative trial. Contraception 1994;49(1):56-72. Hubacher D, Lara-Ricalde R, Taylor DJ, et al. Use of copper intrauterine devices and the risk of tubal infertility among nulligravid women. N Engl J Med. 2001;345(8):561-7. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Svensson L. JAMA. 1984; Sivin I. Contraception. 1991; Farley TM. Lancet. 1992; Andersson K. Contraception. 1994; Hubacher D. N Engl J Med

36 Patient Screening and Counseling for IUC
[Insert Lecture Name Here] Patient Screening and Counseling for IUC Chapter 3: Patient Screening and Counseling for IUC --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC).

37 Screening & Counseling Goals for Providers
Review contraceptive options with patients Allow patients to hold devices Promote successful use of method Allow time for questions Provide written materials in the appropriate language and literacy level Talking Points The following are screening and counseling goals for providers: Review contraceptive options with patients. Allow patients to hold the devices. Promote successful use of the method. Allow time for questions. Provide written materials in the appropriate language and literacy level. Providers should try to encourage selection of a method during prenatal care. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC).

38 ≥18 pregnancies per 100 women in 1 year
Comparing Typical Effectiveness of Contraceptive Methods More effective Less effective <1 pregnancy per 100 women in 1 year ≥18 pregnancies per 100 women in 1 year Injections: Get repeat injections on time. Pills: Take a pill each day. Patch, ring: Keep in place, change on time. Diaphragm: Use correctly every time you have sex. How to make your method most effective After procedure, little or nothing to do or remember Vasectomy: Use another method for first 3 months after procedure. Condoms, sponge, withdrawal, spermicides: Use correctly every time you have sex. Fertility awareness–based methods: Abstain or use condoms on fertile days. Newest methods (Standard Days Method and Two-Day Method) may be the easiest to use and consequently more effective. Injectable Pills Female Condoms Spermicides Female Sterilization Vasectomy Ring Patch Male Condoms Implant Diaphragm Fertility Awareness–Based Methods Withdrawal IUC Sponge 6-12 pregnancies per Talking Points This slide presents a comparison of the typical effectiveness of contraceptive methods, which patients may find useful. It has been adapted from the WHO’s chart “Comparing Effectiveness of Family Planning Methods.” IUC is considered a “top-tier” or “forgettable” method because fewer than 1 pregnancy per 100 women occurs in a year with the use of this method. Extremely effective methods prevent pregnancy more than 99% of the time. These methods include male or female sterilization, IUC, and implants. Very effective methods include oral contraceptives, injectables, the patch, and the ring. These methods prevent pregnancy more than 90% of the time. The male and female condom, sponge, and diaphragm are moderately effective. Fertility awareness methods (e.g., Standard Days method, Two-Day method, ovulation method, and symptothermal method), the cervical cap, spermicides, and withdrawal are likely to prevent pregnancy about 75% of the time. This chart is available at References Trussell J. Contraceptive efficacy. In: Hatcher RA, Trussell J, Nelson AL, et al., eds. Contraceptive Technology. 20th revised ed. New York: Ardent Media; 2011. World Health Organization. Comparing Effectiveness of Family Planning Methods. Geneva: World Health Organization; 2007. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Trussell J. 2011; WHO Chart adapted from WHO 2007.

39 Outcomes for Women Referred for Sterilization
[Insert Lecture Name Here] Outcomes for Women Referred for Sterilization 15% did not attend clinic 54% had sterilization 29% chose alternative method Talking Points A retrospective study of 100 women in the United Kingdom who were referred to a gynecology clinic when they requested sterilization found that 15% did not show up at the clinic, 54% had the sterilization procedure, and 29% chose another method. Alternative methods discussed at the clinic were LNG IUS, vasectomy, and subdermal progesterone implants. At the clinic, 82% of women chose sterilization, but 21% of these women canceled the surgery. Conclusion: Almost half of women referred for sterilization did not proceed with it, suggesting that there was insufficient counseling about sterilization and alternative long-term contraception before referral to the gynecology clinic and within the clinic itself. Reference Smith RA, Martindale EA. Outcomes of women referred for sterilisation. J Fam Plann Reprod Health Care. 2006;32(3):184-5. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). N = 100 women Smith RA. J Fam Plann Reprod Health Care

40 Appropriate Candidates for IUC
[Insert Lecture Name Here] Appropriate Candidates for IUC Women of any reproductive age seeking long-term, highly effective contraception Women of any reproductive age seeking long-term, highly effective contraception Talking Points IUC is especially appropriate for: Women who are at low risk for STIs because they are in a mutually monogamous relationship or because they use condoms correctly and consistently Women who are looking for a convenient method Women who are considering sterilization However, appropriate candidates include all women of reproductive ages who are seeking a long-term, highly effective contraceptive. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC).

41 Appropriate Candidates for IUC
Copper T IUD Women who don’t want hormonal contraception Women seeking emergency contraception Nulligravid women LNG 52 IUS Women who want less menstrual flow Women who experience dysmenorrhea or dysfunctional uterine bleeding LNG 13.5 IUS Women who want a lower-dose LNG IUD Talking Points The Copper T IUD is a good method for women who don’t want hormonal contraception, and it can be used in nulligravid women. It also is a good method for women seeking a form of emergency contraception. The LNG 52 IUS (Mirena®) is a good method for women who wish to reduce their menstrual flow or who experience dysmenorrhea or dysfunctional uterine bleeding. It can be used in nulligravid women. The LNG 13.5 IUS (SkylaTM) is smaller than the LNG 52 IUS (Mirena®) and is a good method for nulligravid women or those who wish to have a lower-dose LNG IUD. References ParaGard® Prescribing Information. Sellersville, PA: Teva Women’s Health, Inc., a subsidiary of Teva Pharmaceuticals, Inc. Available at Retrieved April 15, 2013. Mirena® Prescribing Information. Wayne, NJ: Bayer HealthCare Pharmaceuticals. Available at Retrieved April 15, 2013. SkylaTM Prescribing Information. Wayne, NJ: Bayer HealthCare Pharmaceuticals. Available at Retrieved April 15, 2013. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). ParaGard® PI. 2013; Mirena® PI. 2013; SkylaTM PI

42 Contraindications to IUC
[Insert Lecture Name Here] Contraindications to IUC There are few contraindications to IUC use Known or suspected pregnancy Puerperal sepsis Immediate post- septic abortion Unexplained vaginal bleeding Uterine fibroids that interfere with placement Uterine distortion (congenital or acquired) Active purulent cervicitis/PID Talking Points Note that these screening guidelines differ from those in the manufacturer’s package insert. There are few absolute contraindications to IUC. The listed conditions are rated Category 4, according to the CDC and WHO Medical Eligibility Criteria for Contraceptive Use. Conditions assigned to Category 4 are those that represent an unacceptable health risk if the contraceptive method is used. In addition to these conditions, active endometrial cancer and cervical cancer may be a contraindication, depending on whether the condition develops at the initiation of IUC use or while the woman is already using the method. At the initiation of IUC use, active endometrial cancer and cervical cancer are contraindications (Category 4); however, if the woman develops the condition while she is using IUC, it is a Category 2 and not a contraindication. According to the CDC and WHO Medical Eligibility Criteria for Contraceptive Use, for these two conditions there is concern about the increased risk of infection and bleeding at insertion. The IUD will probably need to be removed at the time of treatment. For complete information about relative contraindications, see the CDC criteria, available at or the WHO criteria, available at References Centers for Disease Control and Prevention. U.S. Medical Eligibility Criteria for Contraceptive Use, MMWR Recomm Rep. 2010;59(RR-4):52-63. World Health Organization. Medical Eligibility Criteria for Contraceptive Use. 4th ed. Geneva: WHO; 2009. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). CDC. MMWR; WHO

43 IUC Use for Adolescents
[Insert Lecture Name Here] IUC Use for Adolescents Appropriate for properly selected and counseled adolescents Follow-up and side-effect monitoring are important Encourage use of condoms with new partners Talking Points Adolescents are typically considered poor candidates for IUC because they may have a high risk of exposure to gonorrhea or chlamydia. The Contraceptive CHOICE Project found that when financial barriers were removed and candidates were properly counseled, they overwhelmingly selected LARC methods, which include IUC. 9,256 women ages of were enrolled in this study. After receiving counseling, more than 40% of women ages chose IUC. At a 1-year follow-up visit, 80% of women who chose the Copper T IUD and 86% of women who selected the LNG 52 IUS (Mirena®) were still satisfied with their method. Only 54% of women who chose a non-LARC method (i.e., birth control pill, patch and ring) were still satisfied with their method. A Canadian study of 28 patients ages 21 and under found that when candidates are properly selected and counseled, an IUC method (in this case, the copper IUD) can be an appropriate and effective choice—especially for adolescents who have already had a pregnancy, those in whom other methods have failed, and those who have refused other contraceptive methods. In this study, 35% of the patients discontinued IUC use an average of 13.4 months after insertion, most due to increased bleeding. Eight-five percent of users were somewhat satisfied, satisfied, or very satisfied with the method. The authors stated that LNG IUS also might be appropriate for some teens because it may offer non-contraceptive benefits in the form of relief of menstrual cramping. References Washington University School of Medicine in St. Louis: The Contraceptive Choice Project. Available at Retrieved April 2013. Eisenberg D, McNicholas C, Peipert JF. Cost as a barrier to long-acting reversible contraceptive (LARC) use in adolescents. J Adolesc Health. 2013;52(4 Suppl):S59-63. Rosenstock JR, Peipert JF, Madden T, et al. Continuation of reversible contraception in teenagers and young women. Obstet Gynecol. 2012;120(6): Secura GM, Allsworth JE, Madden T, et al. The Contraceptive CHOICE Project: reducing barriers to long-acting reversible contraception. Am J Obstet Gynecol. 2010;203(2):115.e1-7. Tomas A, Jamieson MA. Revisiting the intrauterine contraceptive device in adolescents. J Pediatr Adolesc Gynecol. 2006;19(4):291-6. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). The Contraceptive Choice Project. 2013; Eisenberg D. J Adolesc Health. 2013; Rosenstock JR. Obstet Gynecol. 2012; Secura GM. Am J Obstet Gynecol. 2010; Tomas A. J Pediatr Adolesc Gynecol

44 Copper T IUD Labeling Does Not Exclude Nulliparous Women
[Insert Lecture Name Here] Copper T IUD Labeling Does Not Exclude Nulliparous Women Copper T labeling change was approved in 2005 to include more potential candidates beyond women who have had one child and are in a mutually monogamous relationship Talking Points Before a labeling change in 2005, the product information for ParaGard® stated that the device was recommended for women “who have had at least one child, are in a stable, mutually monogamous relationship, and have no history of pelvic infection.” Current labeling does not exclude nulliparous women or those who are not in a mutually monogamous relationship. The prescribing information for the LNG 52 IUS (Mirena®) recommends that this method is best suited for a woman who has had at least one child, is in a stable, mutually monogamous relationship, and has no history of pelvic infection. Clinicians sometimes choose nulliparous candidates for use of either type of IUC (ie, copper or LNG). References ParaGard® Prescribing Information. Sellersville, PA: Teva Women’s Health, Inc. a subsidiary of Teva Pharmaceuticals, Inc. Available at Retrieved April 15, 2013. ParaGard® labeling, Duramed Pharmaceuticals, Inc., May 2006. ParaGard® labeling, Ortho-McNeil Pharmaceuticals, Inc., September 2000. Mirena® Prescribing Information. Wayne, NJ: Bayer HealthCare Pharmaceuticals. Available at Retrieved April 15, 2013. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). ParaGard® PI; Mirena PI.

45 Case Presentation: Nulligravid Adolescent
“Anna,” 17-year-old high-school senior Has been sexually active with boyfriend for 3 months Has been using condoms for birth control Does not want to use hormonal method of contraception Talking Points Our first case presentation we’ll call “Anna,” a 17-year-old senior in high school who has been sexually active for 3 months. The couple has been using condoms, but Anna desires a low-maintenance, very effective method. She does not want to use a hormonal method of contraception because of associated side effects of weight gain and acne. She does not have severe dysmenorrhea. The Copper T IUD, the LNG 13.5 IUS, or the LNG 52 IUS may be an appropriate choice for Anna. All are highly effective, “forgettable” methods of contraception. Anna should be informed that, after the first few months of use of the LNG 13.5 IUS or the LNG 52 IUS, very little LNG enters the circulation. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Consider: Copper T IUD, LNG 13.5 IUS, or LNG 52 IUS* *After the first few months, very little LNG enters the circulation.

46 Nulligravid Adolescent: Clinical Considerations
Insertion may be difficult (smaller cervical os and uterus than in parous woman) Insertion pain Possible increased risk of STIs (chlamydia) and PID (because of age <25 years) Talking Points Anna is a nulligravida. Therefore, among the clinical concerns regarding her use of IUC are insertion difficulty due to a smaller cervical opening and smaller uterus than would be found in a woman who has had one or more pregnancies. These concerns are also accompanied by a greater likelihood of insertion pain. Although Anna currently has a steady boyfriend, women under age 25 (including adolescents) are statistically more likely to have more than one sexual partner over time, which raises concerns about the possibility of STI—particularly chlamydia—and the accompanying risk of upper-genital-tract infection. However, studies show that the risk of PID with IUC in the presence of a sexually transmitted infection (STI) is comparably low to the risk without IUC. References Deans EI, Grimes DA. Intrauterine devices for adolescents: a systematic review. Contraception. 2009;79(6): Grimes DA. Intrauterine device and upper-genital-tract infection. Lancet. 2000;356(9234): --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Deans EI. Contraception. 2009; Grimes DA. Lancet

47 Nulligravid Adolescent: Practice Tips
Can do same-day STI testing (with normal clinical exam): No need to wait for test results before insertion Positive tests should prompt treatment without need to remove device Clinical Pearl Talking Points Testing for chlamydia can be done on the same day of IUD insertion, if the clinical examination is normal (e.g., no cervicitis). If either test result is positive, treatment can be initiated without the need to remove the IUD. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). more…

48 Nulligravid Adolescent: Practice Tips (continued)
Non-pharmacologic pain management: Reassure patient about the procedure “Verbicain” or distraction therapy Pharmacologic pain management: NSAID before procedure Paracervical block Clinical Pearl Talking Points Clinicians have found that reassuring the patient about the procedure and letting her know that they will do everything possible to make her comfortable actually helps relieve anxiety that can increase pain and vasovagal reactions. Clinicians can employ interpersonal techniques to reduce the patient’s perception of pain. These techniques, commonly know as “verbicain” or distraction therapy, can allow the clinician to manage the patient’s anxiety verbally, which can help make the procedure easier for both the patient and the clinician. Simple steps can be taken to reduce patients' pain and anxiety: Describe what the patient will experience. Encourage muscle relaxation. Distract the patient. Recognize her pain. Regarding pharmacologic methods, there are many anecdotal and theoretical methods used to reduce insertion pain, but to date, no quality research trials have shown these methods to be effective. The patient can be instructed to take an oral nonsteroidal anti-inflammatory drug (NSAID), 400 mg orally, at insertion; however, in a randomized trial by Hubacher et al., an oral NSAID was not shown to be helpful at insertion. It is, however, helpful for pain and bleeding after the procedure. A paracervical block may be used for pain management. Many women tolerate insertion without a paracervical block, particularly at the time of menstruation. To assist with pain, some clinicians follow the “1-2-3” rule for lidocaine instillation into the endometrial cavity: Intrauterine instillation of lidocaine may be used for insertion pain; however, in a review of several randomized controlled trials, it was shown that the use of local anesthetics was not helpful in reducing pain during IUD insertion, although another study showed local anesthesia to reduce pain associated with tenaculum placement. Use 1 mL of 2% lidocaine and wait 3 minutes before starting the insertion procedure. Many clinicians routinely use 200–800 g of misoprostol, orally, buccally, or vaginally a few hours before insertion, to help dilate the cervix to facilitate insertion and decrease pain. Recent studies have called into question the routine use of misoprostol to reduce pain during insertion and indicated that its use appears to increase preinsertion side effects (cramps, nausea, low fever). In a randomized, controlled study of 108 nulliparous women, participants were asked to rate their discomfort before, during, and after IUD insertion. The only difference between women who received misoprostol and women who received placebo was that women who received misoprostol were more likely to experience discomfort before IUD insertion. Participants who received misoprostol before IUD insertion reported significantly higher pain scores before placement. In a randomized, controlled study of 35 nulliparous women, participants who received misoprostol reported significantly more preinsertion nausea (29%) and cramping (47%) than the placebo group (5% and 16%, respectively). Provider-reported ease of insertion was not significantly different between the groups; however, three participants in the placebo group required additional dilation, whereas none in the misoprostol group required additional dilation. References Czarnecki ML, Turner HN, Collins PM, et al. Procedural pain management: a position statement with clinical practice recommendations. Pain Manag Nurs. 2011;12(2): Reproductive Health Access Project. Non-pharmacologic pain management. Contraceptive Pearls. July Available at https://org2.democracyinaction.org/o/5854/content_item/pearl-july Retrieved April 15, 2013. Edelman AB, Schaefer E, Olson A, et al. Effects of prophylactic misoprostol administration prior to intrauterine device insertion in nulliparous women. Contraception. 2011;84(3):234-9. Grimes DA, Hubacher D, Lopez LM, et al. Non-steroidal anti-inflammatory drugs for heavy bleeding or pain associated with intrauterine-device use. Cochrane Database Syst Rev. 2006;(4):CD Hubacher D, Reyes V, Lillo S, et al. Pain from copper intrauterine device insertion: randomized trial of prophylactic ibuprofen. Am J Obstet Gynecol. 2006;195(5): Allen RH, Bartz D, Grimes DA, et al. Interventions for pain with intrauterine device insertion. Cochrane Database Syst Rev. 2009;(3):CD Rabin JM, Spitzer M, Dwyer AT, et al. Topical anesthesia for gynecologic procedures. Obstet Gynecol. 1989;73(6): Speroff L, Darney P. A Clinical Guide for Contraception. 4th ed. Philadelphia: Lippincott Williams & Wilkins; 2005. Swenson C, Turok DK, Ward K, et al. Self-administered misoprostol or placebo before intrauterine device insertion in nulliparous women: a randomized controlled trial. Obstet Gynecol. 2012;120(2 Pt 1):341-7. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). more… Czarnecki ML. Pain Manag Nurs. 2011; Reproductive Health Access Project. 2012; Edelman AB. Contraception. 2011; Grimes DA. Cochrane Database Syst Rev. 2006; Hubacher D. Am J Obstet Gynecol. 2006; Allen RH. Cochrane Database Syst Rev. 2009; Rabin JM. Obstet Gynecol. 1989; Speroff L. 2005; Swenson C. Obstet Gynecol

49 Nulligravid Adolescent: Counseling Points
[Insert Lecture Name Here] Nulligravid Adolescent: Counseling Points Follow-up and side effect monitoring important Counsel regarding signs of of expulsion Encourage use of condoms with new partners Talking Points Follow-up visits and monitoring of side effects are especially important in adolescents using IUC. One study showed that 35% of adolescent patients discontinued IUC use an average of 13.4 months after insertion, most due to increased bleeding. Eight-five percent of users were somewhat satisfied, satisfied, or very satisfied with the method. Patients should be taught to recognize possible signs of expulsion and instructed to contact their provider if any of these occur: Unusual vaginal discharge Severe cramping or heavy bleeding Longer-than-usual or absent strings protruding from cervix Tip of device protruding from cervix Adolescents using IUC should also be counseled to use condoms with every new sexual partner. Adolescent patients can be counseled to try using NSAIDS with the onset of menstruation and continue for a few days as needed. In an adolescent using the Copper T IUD and having heavy menstrual bleeding, NSAID use can begin a day or so in advance of menses. Not all nuisance bleeding may be due to IUC. Patients reporting this problem should be examined for infection and partial expulsion of the device. Lighter, intermittent bleeding is to be expected with IUS; patients should be counseled to expect this and that it is often self-limiting. References Hubacher D. Copper intrauterine device by nulliparous women: review of side effects. Contraception. 2007;75:S8-11. Toma A, Jamieson MA. Revisiting the intrauterine contraceptive device in adolescents. J Pediatr Adolesc Gynecol. 2006;19:291-6. Grimes DA, Hubacher D, Lopez LM, et al. Non-steroidal anti-inflammatory drugs for heavy bleeding or pain associated with intrauterine-device use. Cochrane Database Syst Rev. 2006;(4):CD --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Hubacher D. Contraception. 2007; Tomas A. J Pediatr Adolesc Gynecol. 2006; Grimes DA. Cochrane Database Syst Rev Slide 49

50 IUD Insertion After Spontaneous or Induced Abortion
[Insert Lecture Name Here] IUD Insertion After Spontaneous or Induced Abortion IUD may be safely inserted immediately after spontaneous or induced abortion IUD insertion is not recommended after septic abortion. Talking Points An IUD may be safely inserted immediately after spontaneous or induced abortion of a routine nature. Event rates following first-trimester terminationexpulsion, pregnancy, and removal for medical reasonsare comparable to those found in studies in which the device was inserted during or immediately after menses. The shorter the period of gestation at the time of spontaneous or induced abortion, the lower the event rates after IUD insertion. Insertion of a Copper T IUD is contraindicated after septic abortion. Package labeling for ParaGard® recommends that insertion of a copper T IUD be delayed until involution of the uterus is complete. References Grimes D, Schulz K, Stanwood N. Immediate post-abortal insertion of intrauterine devices. Cochrane Libr. 2000;4:2. World Health Organization Task Force on Intrauterine Devices for Fertility Regulation, Special Programme of Research, Development and Research Training in Human Reproduction. Stud Fam Plann. 1983;14(4): ParaGard® Prescribing Information. Sellersville, PA: Teva Women’s Health, Inc. a subsidiary of Teva Pharmaceuticals, Inc. Available at Retrieved April 15, 2013. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Grimes D. Cochrane Libr. 2000; WHO. Stud Fam Plann. 1983; ParaGard® PI.

51 Case Presentation: Post-Abortion IUD Insertion
“Ellen,” 28-year-old nullipara Presents for 1-week follow-up after medical abortion Wants highly effective, long-term, “forgettable” contraceptive method Talking Points “Ellen” is a 28-year-old nullipara who underwent a medical abortion 1 week ago. At her follow-up visit, she is seeking a highly effective and “forgettable” contraceptive method. Either the Copper T IUD or the LNG 13.5 IUS (SkylaTM) could be an appropriate choice for this patient. The LNG 52 IUS (Mirena®) might also be an option, but she is nulliparous and the LNG 13.5 IUS (SkylaTM) is smaller and may be a better fit for her uterus. Ellen could consider Implanon® as well, as it is a highly effective and forgettable contraceptive method. Reference Grimes DA, Lopez LM, Schulz KF, et al. Inserting an IUD right after abortion or miscarriage versus a later time. Cochrane Libr. 2000;4:2. Available at Retrieved August 30, 2013. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Consider: Copper T IUD or LNG 13.5 IUS

52 Post-Abortion IUD Insertion: Clinical Considerations
[Insert Lecture Name Here] Post-Abortion IUD Insertion: Clinical Considerations IUD may be safely inserted immediately after spontaneous or induced abortion Advantages: Patient is known not to be pregnant Motivation may be high because patient may be thinking about birth control Studies in US and Finland document significant reductions in repeat abortion Talking Points An IUD may be safely inserted after spontaneous or induced (medical or surgical) abortion. Event rates after first-trimester terminationexpulsion, pregnancy, and removals for medical reasonsare comparable to those found in studies in which the device was inserted during or immediately after menses. The shorter the period of gestation at the time of spontaneous or induced abortion, the lower the event rates after IUD insertion. The World Health Organization recommendations state that an IUD can be inserted safely after a spontaneous or induced abortion during the first trimester after ruling out current genital tract infection, hemorrhage, and genital tract injury. The potential advantages of IUD insertion immediately after elective abortion include the fact that the patient is known not to be pregnant and may be more highly motivated at this time. References Grimes DA, Lopez LM, Schulz KF, et al. Inserting an IUD right after abortion or miscarriage versus a later time. Cochrane Libr. 2000;4:2. Available at World Health Organization. Immediate postabortion insertion of intrauterine devices. Available at Retrieved July 31, 2009. World Health Organization. Task Force on Intrauterine Devices for Fertility Regulation, Special Programme of Research, Development and Research Training in Human Reproduction. Stud Fam Plann. 1983;14(4): ParaGard® Prescribing Information. Sellersville, PA: Teva Women’s Health, Inc., a subsidiary of Teva Pharmaceuticals, Inc. Available at Retrieved April 15, 2013. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Grimes D. Cochrane Libr. 2000; ParaGard® PI. 2013; WHO Slide 52

53 Post-Abortion IUD Insertion: Practice Tips
Medical abortion: Insertion can be done at 1-week follow-up visit Surgical abortion: Insertion can be done: Immediately after procedure At follow-up visit Clinical Pearl Talking Points For patients undergoing a medical abortion, IUD insertion can be done at the 1-week follow-up visit. For patients undergoing surgical abortion, an IUD can be inserted: Immediately after the procedure—this timing has the advantage of not losing a patient to follow-up At the follow-up visit Reference Grimes DA, Lopez LM, Schulz KF, et al. Inserting an IUD right after abortion or miscarriage versus a later time. Cochrane Libr. 2000;4:2. Available at --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Grimes DA. Cochrane Libr

54 Post-Abortion IUD Insertion: Counseling Points
Counsel patient about possible signs of expulsion: Unusual vaginal discharge Severe cramping or heavy bleeding Longer-than-usual or absent strings protruding from cervix Tip of device protruding from cervix Talking Points Because of the possible increased risk of expulsion after post-abortion IUD insertion, patients should be taught to check for the strings of the device and should be counseled about the possible warning signs of expulsion. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC).

55 [Insert Lecture Name Here]
IUC for Postpartum Use May be safely inserted in postpartum women Both LNG IUS and Copper T IUD can be inserted safely within 10 minutes of placental delivery All three IUDs can be used between 10 minutes and 4 weeks Some evidence to suggest higher expulsion rates should not deter insertion in the postpartum period Talking Points Many clinicians postpone the insertion of IUC devices until 12 weeks postpartum because of concerns that earlier insertion may lead to higher rates of expulsion and more complications. However, data now show that the Copper T IUD (ParaGard®) and LNG IUS (Mirena® and SkylaTM) may be inserted safely much earlier. In contrast to WHO guidelines (Category 3), CDC guidelines are less restrictive in regard to insertion of an IUD less than 10 minutes after delivery of the placenta after vaginal or cesarean delivery in women who will, or will not, be breastfeeding. For immediate postplacental insertion, CDC guidelines assign the Copper T IUD to Category 1 and the LNG IUS (Mirena® and SkylaTM) to Category 2. Prescribing information recommends that IUDs should not be inserted until involution of the uterus is complete. References Centers for Disease Control and Prevention. Update to CDC's U.S. Medical Eligibility Criteria for Contraceptive Use, 2010: Revised Recommendations for the Use of Contraceptive Methods During the Postpartum Period. MMWR. 2011;60(26); World Health Organization. Medical Eligibility Criteria for Contraceptive Use. 4th ed. Geneva: WHO --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). CDC. MMWR. 2011; WHO

56 IUC Use During Lactation
[Insert Lecture Name Here] IUC Use During Lactation Effectiveness not decreased Uterine perforation risk unchanged Expulsion rates unchanged Decreased insertional pain Reduced rate of removal for bleeding and pain LNG 52 IUS is comparable to Copper T in breastfeeding parameters Talking Points Chi et al. assessed Copper T IUD use during lactation in 559 breastfeeding women and 590 non-breastfeeding women. Results indicate that the device is at least as effective in women who are breastfeeding as in those who are not. Expulsion rates are similar in lactating and non-lactating women. However, pain at insertion as well as removals for pain and bleeding are lower in women who are breastfeeding than in those who are not. A more recent study found that LNG IUS is comparable to the Copper T IUD in rates of breastfeeding continuation, complete weaning, full breastfeeding, and partial breastfeeding and did not affect infant growth or development. In this study, no cases of uterine perforation occurred in either group. According to the prescribing information, the LNG 13.5 IUS (SkylaTM) and the LNG 52 IUS (Mirena®) are safe to use while breastfeeding, “provided more than 6 weeks have passed since [the patient has given birth].” The prescribing information states that: Clinical trials excluded women who were breastfeeding. Small amounts of progestins pass into the breast milk, resulting in detectable steroid levels in infant serum. The risk of uterine wall perforation is greater in women who are breastfeeding. References Chi I-C, Potts M, Wilkens L, et al. Performance of the TCu-380A device in breast-feeding and non-breastfeeding women. Contraception. 1989;39: Shaamash AH, Sayed GH, Hussein MM, et al. A comparative study of the levonorgestrel-releasing intrauterine system Mirena® versus the Copper T380A intrauterine device during lactation: breast-feeding performance, infant growth and infant development. Contraception. 2005;72(5): SkylaTM Prescribing Information. Wayne, NJ: Bayer HealthCare Pharmaceuticals. Available at Retrieved April 15, 2013. Mirena® Prescribing Information. Wayne, NJ: Bayer HealthCare Pharmaceuticals. Available at Retrieved April 15, 2013. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Chi I-C. Contraception. 1989; Shaamash AH. Contraception. 2005; Skyla™ PI. 2013; Mirena® PI. 2013

57 Case Presentation: Heavy Menstrual Bleeding
“Diane,” 24-year-old nulligravida Medical history: heavy menstrual bleeding, dysmenorrhea Presents for relief of heavy bleeding and cramping Talking Points “Diane” is a 24-year-old nulligravida who reports a history of very heavy periods with severe cramping that interfere with daily functioning for 2–4 days each month. She has taken oral contraceptives (OCs) in the past but dislikes having to remember to take a pill every day. The LNG 52 IUS (Mirena®) may be an appropriate choice for Diane, if the cause of the heavy menstrual bleeding can first be ruled out (see next slide). She could also consider depot-medroxyprogesterone, which would help both the heavy bleeding and the severe cramping. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Has tried OCs in the past, dislikes having to take a daily pill Consider: LNG 52 IUS

58 Heavy Menstrual Bleeding: Clinical Considerations
Evaluate for underlying cause of heavy bleeding Differential diagnoses: Coagulopathy Endometrial lesion, fibroid, or polyp Anovulation Talking Points In a patient with heavy menstrual bleeding, the underlying cause should be determined before IUD placement is considered: Coagulopathy—this is not typically a contraindication for IUC Endometrial lesion, fibroid, or polyps—IUC may be considered depending on the number, size, nature, and location of intrauterine growths. Chronic anovulation References James AH, Kouides PA, Abdul-Kadir R, et al. Von Willebrand disease and other bleeding disorders in women: consensus on diagnosis and management from an international expert panel. Am J Obstet Gynecol. 2009;201(1):12.e1-8. Epub 2009 May 30. Kingman CEC, Kadir RA, Lee CA, et al. The use of levonorgestrel-releasing intrauterine system for treatment of menorrhagia in women with inherited bleeding disorders. Br J Obstet Gynaecol. 2004;111: Mansour D. Modern management of abnormal uterine bleeding—the levonorgestrel intra-uterine system. Best Pract Res Clin Obstet Gynecol. 2007;21(6): --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). James AH. Am J Obstet Gynecol. 2009; Kingman CEC. Br J Obstet Gynaecol. 2004; Mansour D. Best Pract Res Clin Obstet Gynecol

59 Heavy Menstrual Bleeding Case: Practice Tips
Evaluate cause: Menstrual history History of other types of bleeding suggesting coagulopathy Endometrial biopsy Possible vaginal ultrasound Sonohysterogram Clinical Pearl Talking Points Obtaining a menstrual history is key to rule out an underlying cause of heavy menstrual bleeding. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC).

60 Heavy Menstrual Bleeding Case: Counseling Points
To be expected: Lower volume of menstrual bleeding Dysmenorrhea may improve Breakthrough spotting Unpredictable bleeding 3–6 months for LNG 52 IUS to have full effect on endometrium Talking Points The patient should be counseled that: A decrease in menstrual bleeding and in dysmenorrhea can be expected. Some breakthrough spotting may be experienced. Irregular and/or unpredictable bleeding is common. It may take 3–6 months for the LNG 52 IUS (Mirena®) to have its full effect n the endometrium, so dysmenorrhea may continue until this time. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC).

61 Case Presentation: Uterine Fibroids
“Barbara,” 42-year-old G3P3 Medical history: Uterine fibroids Obesity (BMI = 35) Heavy menstrual bleeding, dysmenorrhea Has completed childbearing, does not desire sterilization Seeks nonsurgical treatment for fibroids Talking Points The next case is about “Barbara,” a woman in her 40s with three children. She has been diagnosed with uterine fibroids. She is obese, with a body mass index (BMI) of 35. She reports heavy menstrual bleeding and severe cramping during her periods. Barbara has completed her childbearing and does not wish to undergo a sterilization procedure. She seeks information about nonsurgical treatments for her fibroids. If certain conditions are met (see next slide), the LNG 52 IUS (Mirena®) may be an appropriate choice for Barbara to reduce fibroid-associated heavy bleeding and pain. If the LNG IUS is appropriate in Barbara’s case, she may opt to continue this form of IUC into the perimenopausal period to ameliorate menopausal symptoms. References Kaunitz AM. Progestin-releasing intrauterine systems and leiomyoma. Contraception. 2007;75(6 Suppl):S130-3. World Health Organization. Medical Eligibility Criteria for Contraceptive Use. 4th ed. Geneva: WHO --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Consider: LNG 52 IUS more… Kaunitz AM. Contraception. 2007; WHO

62 Uterine Fibroids: Clinical Considerations
Obesity may complicate location of uterus and/or cervical os Fibroids must not obstruct cervical os Fibroids distal to uterine cavity do not preclude IUC use Talking Points Neither uterine fibroids nor obesity is an absolute contraindication to IUC, but some special considerations need attention: In obese (BMI ≥ 30) individuals, it may be difficult to locate and/or access the cervical os. Fibroids should not obstruct the cervical opening or distort the uterine cavity. [WHO 2009] Fibroids that are not near the uterine cavity need not preclude the use of IUC. References Kaunitz AM. Progestin-releasing intrauterine systems and leiomyoma. Contraception 2007;75(6 Suppl):S130-3. World Health Organization. Medical Eligibility Criteria for Contraceptive Use. 4th ed. Geneva: WHO --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Kaunitz AM. Contraception. 2007; WHO

63 Uterine Fibroids: Practice Tips for Obese Patients
To determine fibroid size and location: Transvaginal ultrasound Use clinical judgment Clinical Pearl Talking Points Transvaginal ultrasound may be used to determine the size and location of fibroids. Clinical judgment should be used. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). more…

64 Uterine Fibroids: Practice Tips for Obese Patients (continued)
To visualize cervix: Clinical Pearl Talking Points To gain a clear view of the cervical opening in obese patients: A speculum with four blades (available at or an extra-large Graves speculum can be used, as can lateral vaginal retractors and assistants to retract the vaginal walls. If the vaginal walls obscure the opening of the cervix, cut off the tip of a condom and place it over the speculum to retract the vaginal walls. Sometimes all that is needed is a better light source. The patient can be positioned in the McRoberts position (on her back with her knees drawn up toward her chest) or on her hands and knees. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC).

65 Uterine Fibroids: Counseling Points
Expulsion rates possibly higher for women with fibroids Counsel patient about possible signs of expulsion: Unusual vaginal discharge Severe cramping or heavy bleeding Longer-than-usual or absent strings protruding from cervix Tip of device protruding from cervix Talking Points Reports show a possible increase in expulsion rate of IUDs in the presence of uterine fibroids. LNG IUS expulsion rates appear to be slightly higher in menorrhagic women with fibroids than in those without fibroids. Patients should be taught to check for the strings of the IUD and should be counseled about the possible warning signs of expulsion. Reference Kaunitz AM. Progestin-releasing intrauterine systems and leiomyoma. Contraception. 2007;75(6 Suppl):S130-3. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Kaunitz AM. Contraception

66 Case Presentation: Cervical Stenosis
“Cathy,” 32-year-old G1P1 Medical history: Cervical stenosis after LEEP Seeking long-term, “forgettable” contraceptive method Talking Points “Cathy” is a 32-year-old woman who has one child. After an abnormal Pap smear, she underwent a loop electrosurgical excision procedure (LEEP). She has since been diagnosed with uterine cervical stenosis. She has a history of high blood pressure, which precludes the use of hormonal contraception. She seeks a long-term, “forgettable” contraceptive option. The Copper T IUD, LNG 13.5 IUS (SkylaTM), or LNG 52 IUS (Mirena®) may be appropriate choices for Cathy. The LNG 13.5 IUS (SkylaTM) is smaller in size than the LNG 52 IUS (Mirena®) and therefore may be preferable. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Consider: Copper T IUD, LNG 13.5 IUS, or LNG 52 IUS

67 Cervical Stenosis: Clinical Considerations
Insertion difficulty Insertion pain Talking Points Uterine cervical stenosis is not an absolute contraindication to IUD insertion. The chief considerations are difficulty of insertion and pain with insertion. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC).

68 Cervical Stenosis: Practice Tips
Os finder as needed Cervical dilation: Start with lacrimal duct probe Increase size until regular dilators will pass Consider ultrasound guidance Needs experienced hands Pain management options: Oral NSAIDs Paracervical block Consider parenteral analgesia (midazolam and fentanyl) Clinical Pearl Talking Points Cervical stenosis after LEEP is primarily an issue of external cervical os stenosis. An os finder may be useful in some cases. Gradual dilation of the cervix may be necessary, starting with a lacrimal duct probe and increasing the dilator size until regular dilators will pass. This procedure is best performed by experienced hands. Ultrasound guidance may be considered. Some clinicians find that misoprostol can be helpful with cervical dilation. However, recent studies have called into question the routine use of misoprostol to reduce pain during insertion and have indicated that its use appears to increase preinsertion side effects (cramps, nausea, or low fever). Additionally, in these studies provider-reported ease of insertion was not significantly different between the participants who received the misoprostol and the participants who received a placebo. NSAIDs or paracervical block may be used for pain management. Parenteral analgesia with midazolam and fentanyl may also be considered. References Güney M, Oral B, Mungan T. Efficacy of intrauterine lidocaine for removal of a “lost” intrauterine device. Obstet Gynecol. 2006;108(1): Edelman AB, Schaefer E, Olson A, et al. Effects of prophylactic misoprostol administration prior to intrauterine device insertion in nulliparous women. Contraception. 2011;84(3):234-9. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Güney M. Obstet Gynecol. 2006; Edelman AB. Contraception

69 Cervical Stenosis: Counseling Points
Counsel patient about the chance of insertion failure Potential for vasovagal reaction Have patient get up from horizontal position slowly and in stages If future colposcopy is needed, IUD can remain in place Continue Pap screening per recommended schedule Talking Points Patients with cervical stenosis should also be counseled that there is a possibility that insertion will fail. After insertion, there is the potential for vasovagal reaction, even if paracervical block has been used. The patient should get up from a horizontal position slowly and in stages. If needed in the future, colposcopy can be performed with the IUD remaining in place. A woman with uterine cervical stenosis should continue with her regular Pap screening schedule according to her clinician’s recommended schedule. The IUD does not cause abnormal Pap test results. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC).

70 [Insert Lecture Name Here]
IUC Use for Older Women LNG 52 IUS can be an appropriate choice for perimenopausal women, especially those with dysfunctional uterine bleeding LNG 52 IUS can be used off- label as an adjunct to estrogen therapy for postmenopausal women Talking Points The LNG 52 IUS (Mirena®) may be an appropriate contraceptive for a perimenopausal woman with heavy bleeding, because it reduces menstrual flow. After menopause, the LNG 52 IUS (Mirena®) may be used as an adjunct to estrogen therapy. This is an off-label use. References Penney G, Brechin S, de Souza A, et al. FFPRHC Guidance (January 2004). The copper intrauterine device as long-term contraception. J Fam Plann Reprod Health Care. 2004;30(1):29-42. Varila E, Wahlstrom T, Rauramo I. A 5-year follow-up study on the use of a levonorgestrel intrauterine system in women receiving hormone replacement therapy. Fertil Steril. 2001;76(5): Peled Y, Perri T, Pardo Y, et al. Levonorgestrel-releasing intrauterine system as an adjunct to estrogen for the treatment of menopausal symptoms—a review. Menopause. 2007;14(3 Pt 1):550-4. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Penney G. J Fam Plann Reprod Health Care. 2004; Varila E. Fertil Steril. 2001; Peled Y. Menopause

71 LNG 52 IUS Can Be Combined with Oral Estrogen During Menopause
[Insert Lecture Name Here] LNG 52 IUS Can Be Combined with Oral Estrogen During Menopause High intrauterine/low systemic progestin reduces vaginal bleeding while minimizing progestin side effects Endometrium remains in nonproliferative state with no hyperplasia Talking Points Continuous oral progestin given to oppose estrogen during menopause is often accompanied by the side effect of irregular bleeding, which many women find unacceptable. Localized, intrauterine progestin ameliorates the unwanted side effects of systemic progestin while reducing irregular vaginal bleeding. Patients should be counseled regarding the pattern of unscheduled spotting or bleeding that might be expected with the ordinary presence of the IUD immediately after insertion. Continued use of the device in menopause leads to a more profound endometrial suppression and no bleeding. In women using the LNG 52 IUS (Mirena®) for contraception, the endometrium remained in a nonproliferative, atrophic state with no hyperplasia. References Boon J, Scholten PC, Oldenhave A, et al. Continuous intrauterine compared with cyclic oral progestin administration in perimenopausal HRT. Maturitas. 2003;46(1):69-77. Peled Y, Perri T, Pardo Y, et al. Levonorgestrel-releasing intrauterine system as an adjunct to estrogen for the treatment of menopausal symptoms—a review. Menopause. 2007;14(3):550-4. Suvanto-Luukkonen E, Kauppila A. The levonorgestrel intrauterine system in menopausal hormone replacement therapy: five-year experience. Fertil Steril. 1999;72(1):161-3. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Boon J. Maturitas. 2003; Peled Y. Menopause. 2007; Suvanto-Luukkonen E. Fertil Steril

72 LNG 52 IUS Can Reduce Other Progestin-Related Side Effects
Studies of LNG 52 IUS as progestin component of hormone replacement therapy: Endometrial changes—Decreased or no proliferation; no cases of premalignant transformation Breast cancer—Possible reduced risk with non- systemic progestin administration Both older IUCs (Copper T and LNG 52 IUS) have shown an association with reduced incidence of endometrial cancer Talking Points In addition to reducing vaginal bleeding or spotting, the LNG 52 IUS (Mirena®) appears to reduce other progestin-related side effects. A number of studies have evaluated the effects of the LNG 52 IUS (Mirena®) used as the progestin component of hormone replacement therapy: Women using the LNG 52 IUS (Mirena®) showed reduced or no endometrial proliferation compared with those taking oral progestins. Oral or transdermal progestin has been associated with an increased risk of breast cancer. This risk appears to be linked to high circulating plasma levels of progestins. The LNG 52 IUS (Mirena®) and the LNG 13.5 IUS (SkylaTM) result in much lower plasma levels of circulating LNG. A reduced risk of breast cancer is possible but is still speculative at this time. Both older IUCs (Copper T IUD and LNG 52 IUS) have shown an association with reduced incidence of endometrial cancer. Two studies have shown a 40% reduction in cervical cancer with IUDs; although intriguing, this finding was not statistically significant. Reference Peled Y, Perri T, Pardo Y, et al. Levonorgestrel-releasing intrauterine system as an adjunct to estrogen for the treatment of menopausal symptoms—a review. Menopause. 2007;14(3):550-4. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Peled Y. Menopause

73 IUC Counseling Topics Effectiveness Mechanism of action
Characteristics of method, including changes in menstrual flow Insertion and removal procedures Side effects and possible complications Instructions on follow- up Non-contraceptive benefits Use of condoms with new partners Talking Points Effectiveness Mechanism of action Characteristics of method, including changes in menstrual flow Insertion and removal procedures Side effects and possible complications Instructions on follow-up Non-contraceptive benefits Use of condoms with new partners IUC does not protect against STIs. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC).

74 Three-Prong Approach to Contraception Education
Discuss efficacy, benefits, and side effects Employ “Teach-Back” method to demonstrate the patient’s understanding Provide time for patient to review and sign informed consent form for LARC procedure Talking Points The three-prong approach allows for three different opportunities for patients to hear and comprehend the benefits and side effects of a LARC method. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC).

75 “Teach-Back” Method Talking Points
BENEFITS Tell me about some of the benefits of this method. How will this method have a positive impact for you? SIDE EFFECTS Tell me the three most common normal side effects women have when they start this method. Tell me what you will use if you experience cramps. FOLLOW-UP What would be abnormal symptoms with this method? Tell me what you will do if you experience spotting that is bothering you. Talking Points Employ the “Teach-Back” method to demonstrate that the patient understands what to expect with use of the method. The Teach-Back method asks the client pointed questions to verify that essential information has been processed. Here are some examples of questions you may want to ask clients about their contraceptive method. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC).

76 [Insert Lecture Name Here]
IUC Use and Follow-up Schedule follow-up visits at: Around 3–6 weeks, at clinician’s discretion Routine well-woman care Advise return visit if there is: Possible expulsion or displacement Severe cramping or bleeding No data on routine thread checks by patient Talking Points Schedule follow-up visits at: Around 3–6 weeks, at clinician’s discretion Routine well-woman care Advise return visit if there is: Possible expulsion or displacement Severe cramping or bleeding No data on routine thread checks by patient Reference Penney G, Brechin S, de Souza A, et al. FFPRHC Guidance (January 2004). The copper intrauterine device as long-term contraception. J Fam Plann Reprod Health Care. 2004;30(1):29-42. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Penney G. J Fam Plann Reprod Health Care

77 Plan Follow-Up for Side Effects
Ensure that patient knows to call or return if having bothersome side effects Create a plan with patient about “preemptive” treatment options in the event of bothersome spotting Reassure that there will be an adjustment period the first few months Discuss a non-prescription treatment plan in the event of cramping Talking Points Following are steps that the clinician should take to ensure that the patient has a plan for follow-up for side effects: Ensure that the patient knows to call or return to see you for bothersome side effects. Create a plan with the patient about “preemptive” treatment options in the event of bothersome spotting. Reassure the patient that there will be an adjustment period for the first few months. Discuss an over-the-counter treatment plan in the event of cramping. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC).

78 [Insert Lecture Name Here]
Patient Follow-up Ask follow-up questions: Are you satisfied with your contraceptive method? Consider speculum string check Is there anything you would change? Are you having bleeding problems or other side effects? Address primary care/annual appointments and STI counseling Talking Points After a woman initiates a new method of contraception, short-term follow-up can increase the likelihood that she will use the method successfully. During a re-check visit occurring within 6 weeks of the time when the patient begins using the new method, health care providers can review concerns about side effects (particularly bleeding changes) and, in the case of IUC users, to ensure that the device remains in place. The visit can be done as a 15-minute “express” (i.e., no examination) office visit in which the patient is asked: Is she satisfied with her contraceptive method? Is there anything she would change? Is she having bleeding problems or any other side effects? This follow-up visit is especially useful for adolescent patients, who often use contraception sporadically and may be ambivalent about pregnancy. Women who are restarting a contraceptive method may not need this short-term follow-up. Sometimes the follow-up can be conducted by telephone or . Depending on the patient, a postcard can be sent as a reminder that it has been 3 months since her visit and that she should call the office if she has any questions or concerns. Nurses and medical assistants should be trained to deal with basic questions about the use of all contraceptive methods. These can be documented in the patient’s chart, and the clinician can be consulted as needed. Reference Association of Reproductive Health Professionals. Clinical Proceedings: Periodic Well-Woman Visit: Individualized Contraceptive Care. April 2004. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). ARHP. Clinical Proceedings

79 IUC Insertion and Management
[Insert Lecture Name Here] IUC Insertion and Management Chapter 4: IUC Insertion and Management --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC).

80 Timing of Insertion for Copper T IUD
First day of LMP: ≤5 days ago >5 days ago Urine pregnancy test negative Insert IUD today First instance of unprotected sex since LMP: Talking Points This algorithm for the Copper T IUD allows insertion to be done on the day that the patient presents for IUC, if certain conditions are met, or within 5 days of the next period. It must be ensured that the patient is not pregnant. Pregnancy testing should be done, especially since adolescents may not recognize the early signs of pregnancy. Use of the algorithm bypasses an overly long waiting period in which the patient may become pregnant. If the pregnancy test is positive, counseling about options should be provided. Oral contraceptives, patch, or ring may be started as a “bridge” to the copper IUD in cases where the IUD should be inserted within 5 days of the next menstrual period. References Centers for Disease Control and Prevention. US selected practice recommendations for contraceptive use, MMWR. 2013;62(5):1-64. Hatcher RA, Zieman M, et al. A Pocket Guide to Managing Contraception. New York: Ardent Media; 2005. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). ≤5 days ago >5 days ago None Insert IUD within 5 days of next menses Insert IUD today Insert IUD today CDC. MMWR. 2013; Hatcher RA

81 Timing of Insertion for LNG IUS
First day of LMP: >5 days ago Insert LNG IUS today Urine pregnancy test negative Unprotected sex since LMP? Insert LNG IUS within 5 days of next menses Yes No Offer pill/patch/ring as bridge to LNG IUS ≤5 days ago Patient accepts pill/patch/ring Patient declines pill/patch/ring, uses barrier method instead 2 weeks later, pregnancy test is negative Talking Points Timing of insertion for the LNG 52 IUS (Mirena®) and the LNG 13.5 IUS (SkylaTM) References Centers for Disease Control and Prevention. US selected practice recommendations for contraceptive use, MMWR. 2013;62(5):1-64. Hatcher RA, Zieman M, Cwiak C, et al. A Pocket Guide to Managing Contraception. New York: Ardent Media; 2005. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Insert LNG IUS today CDC. MMWR. 2013; Hatcher RA

82 Timing of Insertion of IUDs
[Insert Lecture Name Here] Timing of Insertion of IUDs Timing Pros Cons With menses Ensures patient not pregnant Scheduling; interim pregnancy Midcycle, any time Convenience; low rate of expulsion Must rule out pregnancy Emergency contraception (Copper T IUD) Convenience; pregnancy prevention Pregnancy Talking Points IUDs can be inserted at any time during the menstrual cycle, as long as the provider is reasonably certain that the woman is not pregnant. The practice of inserting an IUD only during menses is unnecessary and inconvenient for the patient. When the Copper T IUD is used as emergency contraception (off-label use), existing pregnancy should be ruled out by history and testing for human chorionic gonadotropin, if indicated. The LNG IUS should not be used as emergency contraception. References Alvarez Pelavo J, Borbolla Sala ME. IUD insertion during cesarean section and its most frequent complications. (Spanish.) Ginecol Obstet Mex. 1994;62:330-5. Hatcher RA, Zieman M, Cwiak C, et al. A Pocket Guide to Managing Contraception. New York: Ardent Media; 2005. O’Hanley K, Huber DH. Postpartum IUDs: keys for success. Contraception. 1992;45(4): --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). more… Alvarez Pelavo J. Ginecol Obstet Mex. 1994; Hatcher RA. 2005; O’Hanley K. Contraception

83 Timing of Insertion of IUDs (continued)
[Insert Lecture Name Here] Timing of Insertion of IUDs (continued) Timing Pros Cons Cesarean delivery Convenience; low rate of expulsion Strings may not be visible or palpable at cervix Postplacental Convenience Increased rate of expulsion (7%–15%) Talking Points In the Alvarez Pelavo study, the expulsion rate when an IUD was placed at the time of cesarean delivery was 1.2%. Endometritis occurred in 5.4% of women. This rate was the same as that in women having cesarean delivery without IUD placement. Ultrasound at 6 weeks is recommended for cesarean delivery and postplacental placement to verify that the IUD is retained. Postpartum placement is defined as insertion that occurs less than 48 hours after delivery. IUD placement techniques after placental expulsion in the immediate postpartum period vary, and experienced supervision is suggested if the provider does not have experience in this method. The device can be placed in the fundus by hand or with a ring forceps. Because the risk of spontaneous expulsion is higher after immediate postplacental placement, an assessment of the placement of the device is recommended at the postpartum visit. IUD insertion immediately after abortion or vaginal delivery requires special assessment of the depth of the uterus. After first-trimester abortion when the uterus is firmly contracted, the depth of the uterus can be assessed and the IUD placed using the standard technique. After second-trimester abortion, the uterus is larger and the IUD may be placed at the fundus with the standard inserter or with ring forceps. References Alvarez Pelavo J, Borbolla Sala ME. IUD insertion during cesarean section and its most frequent complications. (Spanish.) Ginecol Obstet Mex. 1994;62:330-5. O’Hanley K, Huber DH. Postpartum IUDs: keys for success. Contraception. 1992;45(4): --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Alvarez Pelavo J, et al. Ginecol Obstet Mex ; O’Hanley K, et al. Contraception

84 Copper T IUD as Emergency Contraception
[Insert Lecture Name Here] Copper T IUD as Emergency Contraception Can be inserted up to 5 days after unprotected intercourse to prevent pregnancy More effective than emergency oral contraceptives Talking Points Insertion of a Copper T IUD is much more effective than the use of emergency oral contraceptives, or mini-pills. The Copper T IUD reduces the risk of pregnancy after unprotected intercourse by more than 99%. Oral emergency contraceptives have the potential to reduce unintended pregnancy by 75%–89%. Side effects after postcoital insertion of an IUD are similar to those seen after routine insertion at other times and include abdominal discomfort and vaginal bleeding or spotting. An LNG IUS should not be used for emergency contraception. D'Souza et al. showed a high overall continuation rate of emergency IUDs at 6 weeks (approximately 80%). References Trussell J, Schwarz EB. Emergency contraception. In: Hatcher RA, Trussell J, Nelson AL, et al., eds. Contraceptive Technology. 20th revised ed. New York: Ardent Media; 2011. D'Souza RE, Masters T, Bounds W, et al. Randomised controlled trial assessing the acceptability of GyneFix versus Gyne-T380S for emergency contraception. J Fam Plann Reprod Health Care. 2003;29(2):23-9. Erratum in: J Fam Plann Reprod Health Care. 2003;29(3):159. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Trussell J. 2011; D’Souza RE

85 Prophylactic Antibiotics Before Insertion
[Insert Lecture Name Here] Prophylactic Antibiotics Before Insertion Antibiotics have not been shown to reduce risk of PID when given prophylactically Talking Points Antibiotics to prevent pelvic infection are not routinely recommended before IUD insertion. References Grimes D, Schulz KF. Prophylactic antibiotics for intrauterine device insertion: A meta-analysis of the randomized controlled trials. Contraception. 1999;60(2):57-63. Grimes DA, Lopez LM, Schulz KF. Antibiotic prophylaxis for intrauterine contraceptive device insertion. Cochrane Database Syst Rev. 1999; Issue 3; Article No. CD Dajani AS, Taubert KA, Wilson W, et al. Prevention of bacterial endocarditis. Recommendations by the American Heart Association. JAMA. 1997;277(22): Penney G, Brechin S, de Souza A, et al. FFPRHC Guidance (January 2004). The copper intrauterine device as long-term contraception. J Fam Plann Reprod Health Care. 2004;30(1):29-41. World Health Organization. Selected Practice Recommendations for Contraceptive Use. Geneva: WHO, 2002. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Grimes D. Contraception. 1999; Grimes DA. Cochrane Database Syst Rev. 1999;Dajani AS. JAMA. 1997; Penney G. J Fam Plann Reprod Health Care. 2004; WHO

86 Signs of Possible Complications
[Insert Lecture Name Here] Signs of Possible Complications Symptom Possible Explanation Severe bleeding or abdominal cramping 3–5 days after insertion Perforation, infection Irregular bleeding and/or pain every cycle Dislocation or perforation Fever, chills, unusual vaginal discharge Infection Talking Points Severe bleeding or abdominal cramping 3–5 days after insertion could be a sign of perforation and or infection. Irregular bleeding and/or pain every cycle can be an indication of dislocation or perforation. Having a fever, chills, and/or unusual vaginal discharge may be a symptom of an infection. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). more…

87 Signs of Possible Complications (continued)
[Insert Lecture Name Here] Signs of Possible Complications (continued) Symptom Possible Explanation Pain during intercourse Infection, perforation, partial expulsion Missed period, other signs of pregnancy, expulsion Pregnancy (uterine or ectopic) Shorter, longer, or missing threads Partial or complete expulsion, perforation Talking Points Pain during intercourse could be a sign of infection, perforation, or partial expulsion. A missed period, other signs of pregnancy and/or expulsion could be an indication of pregnancy (uterine or ectopic). Shorter, longer, or missing threads may indicate partial or complete expulsion or perforation. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC).

88 Management of Cramping
[Insert Lecture Name Here] Management of Cramping Mild: recommend NSAIDs Severe or prolonged: Examine for partial expulsion, perforation, or PID Remove IUD if severe cramping is unrelated to menses or is unacceptable to patient Talking Points For women who experience mild cramping: Recommend NSAIDs For severe or prolonged cramping: Examine for partial expulsion, perforation, or PID Remove IUD if severe cramping is unrelated to menses or is unacceptable to patient Reference Centers for Disease Control and Prevention. US selected practice recommendations for contraceptive use, MMWR. 2013;62(5):1-64. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). CDC. MMWR

89 Management of Heavy Bleeding with IUC
Heavy bleeding lasting >6 months: Evaluate for infection, fibroids, or displaced device Consider ultrasound/x-ray to evaluate bleeding Replace device if displaced For Copper T IUD: Check for anemia and treat if indicated Prescribe NSAIDS If bleeding cannot be managed or is unacceptable to patient, consider removal Talking Points Heavy bleeding may signal pregnancy or device expulsion, but it is more commonly simply a side effect of IUC. Heavy bleeding may lessen over time. Heavy bleeding or cramping is more likely to occur with the Copper T IUD than with the LNG IUS. Users of LNG IUS may become amenorrheic over time. Use of prophylactic NSAIDs can help reduce symptoms. For women who experience heavy bleeding that lasts more than 6 months while using IUC : Check for infection, fibroids, or displaced device Consider ultrasound and/or x-ray to evaluate bleeding Replace device if displaced Specifically for Copper T IUD: Check for anemia and treat if indicated Prescribe NSAIDS If heavy bleeding cannot be managed or is unacceptable to the patient, the device should be removed. Reference Association of Reproductive Health Professionals. Insertion and Management of Intrauterine Contraception. September Available at Retrieved October 2, 2009. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). ARHP

90 LNG 52 IUS: Management of Late Abnormal Bleeding
[Insert Lecture Name Here] LNG 52 IUS: Management of Late Abnormal Bleeding Matched-pair, case-control study 15 users with unacceptable bleeding after >6 months of use vs. 15 control users with no abnormal bleeding Device displacement or leiomyomas detected more commonly in cases than controls Talking Points A study was conducted to determine the causes of abnormal bleeding patterns occurring after at least 6 months of successful use of the LNG IUS. Ultrasonography and hysteroscopy detected more abnormalities (either device displacement or leiomyomas) in case subjects than in controls. Reference Ronnerdag M, Odlind V. Late bleeding problems with the levonorgestrel-releasing intrauterine system: evaluation of the endometrial cavity. Contraception. 2007;75(4): --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). more… Ronnerdag M. Contraception

91 LNG 52 IUS: Management of Late Abnormal Bleeding (continued)
[Insert Lecture Name Here] LNG 52 IUS: Management of Late Abnormal Bleeding (continued) Conclusion: Consider ultrasonography and hysteroscopy to evaluate bleeding in long- term users of LNG IUS Replace device if it is displaced Talking Points The authors reported that the device could be replaced with a new device if displacement was the problem. However, “the data are too limited to provide general guidance about management of bleeding with myomas of various sizes and locations” in regard to replacement or removal. Reference Ronnerdag M, Odlind V. Late bleeding problems with the levonorgestrel-releasing intrauterine system: evaluation of the endometrial cavity. Contraception. 2007;75(4): --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Ronnerdag M. Contraception

92 Bleeding with the Copper T IUD
[Insert Lecture Name Here] Bleeding with the Copper T IUD Bleeding and/or pain rates are highest during first year of use Rates of expulsion and removal for bleeding and/or pain are higher in nulliparous than in parous women Bleeding appears to decrease over time with most users Talking Points In an unpublished study by the World Health Organization, reports of bleeding and/or pain were at their highest within the first year of use of the Copper T IUD. A review of the literature indicates that increased menstrual bleeding is higher among nulliparous than parous women using the Copper T IUD. In a secondary analysis, a review of more than 6,000 patient follow-up forms indicated that the percentage of patients reporting increased menstrual blood loss gradually decreased over time. References Hubacher D. Copper intrauterine device use by nulliparous women: review of side effects. Contraception. 2007;75(suppl):S8-11. Hubacher D, Chen P-L, Park S. Side effects from the copper T IUD: do they decrease over time? Contraception. 2009;79(5): Sivin I. Utility and drawbacks of continuous use of a copper T IUD for 20 years. Contraception. 2007;75(suppl):S70-5. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Hubacher D. Contraception. 2007, 2009; Sivin I. Contraception

93 [Insert Lecture Name Here]
Expulsion Partial or unnoticed expulsion may present as irregular bleeding and/or pregnancy Risk of expulsion related to: Provider’s skill at fundal placement Age and parity of woman Time since insertion Timing of insertion Talking Points The risk of expulsion is lower when the device is inserted less than 48 hours after delivery. Immediate postpartum insertion of the Copper T IUD, particularly when insertion occurs immediately after delivery of the placenta, is associated with lower expulsion rates than delayed postpartum insertion (up to 72 hours postpartum). Post-placental placement at the time of caesarean section is associated with lower rates of expulsion than post-placental placement at the time of vaginal delivery. The risks of insertion complications of perforation and infection are not increased by IUD placement at any time during the postpartum period. References World Health Organization. Medical Eligibility Criteria for Contraceptive Use. 4th ed. Geneva: WHO Centers for Disease Control and Prevention. US Medical Eligibility Criteria for Contraceptive Use. MMWR Recomm Rep. 2010;59(RR04);52-63. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). WHO. 2009; CDC. MMWR

94 Management of Missing Threads
[Insert Lecture Name Here] Management of Missing Threads Rule out pregnancy Probe for threads in cervical canal Prescribe back-up contraceptive method Obtain ultrasound or x-ray, as needed Promptly remove a displaced Copper T IUD in the abdomen Talking Points Options for probing the cervical canal for threads: Use an endocervical brush or a uterine sound to probe for strings in the cervical canal. If this is not effective, try using a thread retractor to snag the strings or alligator forceps to search within the uterine cavity, using a tenaculum to stabilize the uterus before intrauterine manipulation. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC).

95 [Insert Lecture Name Here]
Management of STIs If STI is diagnosed: IUD removal not necessary if symptoms improve within 72 hours of treatment Treat infection Counsel patient about prevention of STI transmission Talking Points IUC users who develop STIs or PID should be tested for relevant organisms and treated with appropriate antibiotic therapy. Clinical guidelines state that removal of the IUD is not necessary unless symptoms fail to improve within 72 hours of the start of treatment. References Penney G, Brechin S, de Souza A, et al. The copper intrauterine device as long-term contraception. J Fam Plann Reprod Health Care. 2004;30(1):29-41. World Health Organization. Selected Practice Recommendations for Contraceptive Use. Geneva: WHO; 2002. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Penney G. J Fam Plann Reprod Health Care. 2004; WHO

96 [Insert Lecture Name Here]
Management of PID If PID is diagnosed: IUD removal may not be necessary Treat infection Recommendations to remove IUD are not evidence based Talking Points If PID is diagnosed: IUD removal may not be necessary Treat infection Recommendations to remove IUD are not evidence based Reference Grimes D. Intrauterine device and upper-genital tract infection. Lancet. 2000;356)9234): --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Grimes D. Lancet

97 Risk of Uterine Perforation
[Insert Lecture Name Here] Risk of Uterine Perforation Rare:1 per 1,000 insertions Perforation risk is linked to: Uterine position and consistency Provider’s skill and experience with technique required Time of insertion after childbirth Risk doubled within first 12 weeks postpartum Perforation risk is reduced through directed training and observation Talking Points Perforation is rare, especially when insertion is performed by experienced providers. The timing of IUD insertion is related to the risk of uterine perforation. The risk is doubled, to approximately 2 per 1,000 insertions, for postpartum insertions performed between 48 hours and 12 weeks after delivery. In a study of more than 8,000 women, Caliskan et al. found that Copper T IUD insertion up to 6 months postpartum increased the risk of uterine perforation. In a study of the LNG IUS, Van Houdenhoven et al. found that insertion in lactating women, even beyond 6 weeks after delivery, was an important risk factor for perforation. References Caliskan E, Ozturk N, Bilbaz BO, et al. Analysis of risk factors associated with uterine perforation by intrauterine devices. Eur J Contracept Reprod Health Care. 2003;8(3):150-5. Van Houdenhoven K, van Kaam KJAF, van Grootheest AC, et al. Uterine perforation in women using a levonorgestrel-releasing intrauterine system. Contraception. 2006;73(3): Prema K, Malhotra U, Choudhury SD, et al. Uterine perforations with copper T IUDs. Contracept Deliv Syst. 1981;2(4):327-9. Markovitch O, Klein Z, Gidoni Y, et al. Extrauterine mislocated IUD: is surgical removal mandatory? Contraception. 2002;66(2):105-8. Harrison-Woolrych M, Ashton J, Coulter D. Uterine perforation on intrauterine device insertion: is the incidence higher than previously reported? Contraception. 2003;67(1):53-6. World Health Organization. Mechanisms of action, safety and efficacy of intrauterine devices: Technical report series 753. Geneva: WHO; 1987. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Caliskan E. Eur J Contracept Reprod Health Care. 2003; Van Houdenhoven K. Contraception. 2006; Prema K. Contracept Deliv Syst. 1981; Markovitch O. Contraception. 2002; Harrison-Woolrych M. Contraception. 2003; WHO

98 Management of Perforation at Insertion
[Insert Lecture Name Here] Management of Perforation at Insertion If perforation occurs at insertion: Remove device Provide alternative contraception Monitor for excessive bleeding Follow-up as appropriate Can insert another device after next menses Talking Points If perforation occurs at insertion: Remove device Provide alternative contraception Monitor for excessive bleeding Follow-up as appropriate Can insert another device after next menses --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC).

99 Pregnancy with IUD in Place
[Insert Lecture Name Here] Pregnancy with IUD in Place Determine site of pregnancy Intrauterine or ectopic Remove IUD if threads are accessible Removal decreases risk of: Spontaneous abortion Premature delivery Talking Points If pregnancy occurs with an IUD in place, it is necessary to determine whether the pregnancy is intrauterine or ectopic. If the threads are visible, remove the IUD as early as possible in the first trimester. Studies indicate that spontaneous abortions are more common in women whose IUDs remain in place than in those whose IUDs are removed in the first trimester. Early IUD removal decreases the risks of first-trimester spontaneous abortion, second-trimester spontaneous abortion, and premature delivery. If ectopic pregnancy occurs, the IUD does not need to be removed. References ParaGard® Prescribing Information. Sellersville, PA: Teva Women’s Health, Inc. a subsidiary of Teva Pharmaceuticals, Inc. Available at Retrieved April 15, 2013. Mirena® Prescribing Information. Wayne, NJ: Bayer HealthCare Pharmaceuticals. Available at Retrieved April 15, 2013. SkylaTM Prescribing Information. Wayne, NJ: Bayer HealthCare Pharmaceuticals. Available at Retrieved April 15, 2013. UK Family Planning Research Network. Pregnancy outcome associated with use of IUDs. Br J Fam Plann. 1989;15:7-10. Foreman H, Stadel BV, Schlesselman S. Intrauterine device usage and fetal loss. Obstet Gynecol. 1981;58(6): Atrash HK, Frye A, Hogue CJR. Incidence of morbidity and mortality with IUD in situ in the 1980s and 1990s. In: Bardin CW, Mishell DR Jr, eds. Proceedings from the Fourth International Conference on IUDs. Boston, MA: Butterworth-Heinemann; 1994:76-87. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). ParaGard® PI. 2013; Mirena® PI. 2013; SkylaTM PI. 2013; UK Family Planning Research Network. Br J Fam Plann. 1989; Foreman H. Obstet Gynecol. 1981; Atrash HK

100 Risk of Fetal Abnormality
[Insert Lecture Name Here] Risk of Fetal Abnormality IUC is extra-amniotic No increase in birth defects for Copper T IUD Talking Points As shown in case-series reports, there is no increase in the incidence of birth defects in infants born at term when the mother has had a copper or progesterone IUD left in place for the duration of the pregnancy. There are no data for the LNG IUS. In a case-control study reported by CDC, IUDs left in place during pregnancy were not associated with an increased incidence of limb reduction defects in infants. This evidence suggests that there is no causal association between the retention of an IUD during pregnancy and an increased risk of birth defects. References Atrash HK, Frye A, Hogue CJR. Incidence of morbidity and mortality with IUD in situ in the 1980s and 1990s. In: Bardin CW, Mishell DR Jr, eds. Proceedings from the Fourth International Conference on IUDs. Boston, MA: Butterworth-Heinemann; 1994:76-87. Layde PM, Goldberg MF, Safra MJ, et al. Failed intrauterine device contraception and limb reduction deformities: a case-control study. Fertil Steril. 1979;31(1):18-20. Simpson JL. Do contraceptive methods pose fetal risks? Res Front Fertil Regul. 1985;3(6):1-11. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Atrash HK. 1994; Layde PM. Fertil Steril. 1979; Simpson JL. Res Front Fertil Regul

101 [Insert Lecture Name Here]
Hands-on Practicum Chapter 5: Hands-on Practicum --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC).

102 Steps for Insertion: Technique Varies According to Product
Perform pelvic exam to assess size and position of uterus Apply speculum, antiseptic, and tenaculum Sound the uterus Load the device Place the device Cut the threads Add documentation to patient’s chart (string length, uterine device, lot number, etc.) Talking Points This slide contains generic instructions for both intrauterine products (the Copper T IUD and the LNG IUS) currently available on the US market. The two products are designed to be inserted using different techniques. The clinician must be familiar with the appropriate insertion technique for the specific device being used. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC).

103 Talking Points To view the Copper T IUD insertion video visit http://www.youtube.com/watch?v=FuPFbgSm0QQ. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC).

104 Animated Insertion: LNG 52 IUS
Talking Points To view the LNG 52 IUS (Mirena®) insertion video, visit http://www.youtube.com/watch?v=hlfV8tKgw6E. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC).

105 Animated Insertion: LNG 13.5 IUS
Talking Points A video of the LNG 13.5 IUS (SkylaTM) insertion can be viewed on the manufacture’s website at --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC).

106 Summary Three forms of IUC approved in U.S.
Copper T IUD, LNG 52 IUS, and LNG 13.5 IUS IUC is the most effective reversible method available There are few contraindications to IUC use Potential side effects of IUC use include changes in menses and cramping Counseling and discussion/management of side effects help increase uptake Talking Points Three forms of IUC are currently available in the United States: the Copper T IUD (ParaGard®), the LNG 52 IUS (Mirena®), and the LNG 13.5 IUS (SkylaTM). These methods are the most effective, reversible methods available in the United States. There are few contraindications to IUC use. Despite misperceptions about IUC, this form of contraception can be a safe, effective, and appropriate choice in: Adolescents Women who have never been pregnant The potential side effects of IUC use include changes in menses and cramping: The Copper T IUD may result in heavier or prolonged menses and increased cramps. During the first 3–6 months of LNG IUS use, bleeding may be irregular and the number of days with bleeding or spotting may be increased from baseline. Increased cramping can also be a side effect with both the LNG 52 IUS (Mirena®) and the LNG 13.5 IUS (SkylaTM). For women who experience mild cramping, recommend NSAIDs For severe or prolonged cramping: Examine for partial expulsion, perforation, or PID Remove IUD if severe cramping is unrelated to menses or unacceptable to patient Up-front counseling and discussion and management of side effects help to increase uptake. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for “A Clinical Update on Intrauterine Contraception: Special Cases” in July Original funding received from Bayer HealthCare Pharmaceuticals through an unrestricted educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC).

107 Resources Association of Reproductive Health Professionals (www.arhp.org) WHO/CDC Medical Eligibility Criteria planning/ /en/index.html ncy/USMEC.htm) Family Pact (www.familypact.org) BEDSIDER (www.bedsider.org) Talking Points The following are resources to obtain information about IUC and contraception in general: Association of Reproductive Health Professionals (ARHP) (www.arhp.org): Hosts a large variety of clinical and patient education fact sheets, Clinical Quick Reference Guides (QRGs), and other tools that provide information about IUC and contraception in general WHO/CDC Medical Eligibility Criteria (http://www.who.int/reproductivehealth/publications/family_planning/ /en/index.html and Gives summary of evidence-based criteria scale On the CDC site there is a useful app called “CDC contraception” Family Pact (www.familypact.org ): Good clinical practice alerts and summary guides Bedsider (www.bedsider.org), an online birth control support network for women operated by The National Campaign to Prevent Teen and Unplanned Pregnancy --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for “A Clinical Update on Intrauterine Contraception: Special Cases” in July Original funding received from Bayer HealthCare Pharmaceuticals through an unrestricted educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC).

108 Supplemental Slides: 109–123
--- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC).

109 LNG 52 IUS vs. OCs in Nulligravid Women: Discontinuation Rates
[Insert Lecture Name Here] LNG 52 IUS vs. OCs in Nulligravid Women: Discontinuation Rates Reason LNG 52 IUS discontinuation rate per 100 OC discontinuation rate per 100 Pain* 6.66 Hormonal 4.95 9.75 Bleeding 2.52 Spotting 1.25 Expulsion 1.20 NA Other medical 2.13 1.09 Talking Points A 1-year randomized Finnish study compared the safety and acceptability of the LNG 52 IUS (Mirena®) (n = 94) and OCs (n = 99) in young, nulliparous women. Nineteen women (20%) in the LNG 52 IUS (Mirena®) group discontinued the study, as did 27 (27%) of the OC group. The most common reason for discontinuation (31%) in the IUC group was pain. The most common reason for discontinuation in the OC group was hormonal side effects. Conclusion: The safety and acceptability of the LNG 52 IUS (Mirena®) for contraception in nulliparous women are as good as with OCs; both methods have high continuation rates. Reference Suhonen S, Haukkamaa M, Jakobsson T, et al. Clinical performance of a levonorgestrel-releasing intrauterine system and oral contraceptives in young nulliparous women: a comparative study. Contraception. 2004;69(5): --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). *Statistically significant difference Suhonen S. Contraception

110 [Insert Lecture Name Here]
Percentage of Women with Fertilized Eggs in Oviducts After Midcycle Coitus Group Normal development (%) No development (%) Abnormal development (%) Control (n = 20) 50 15 35 IUC* (n = 14) 64 36 Talking Points In a study designed to recover ova from the fallopian tubes of 56 women using IUC and 115 women using no contraception, 20 control subjects and 14 IUC users had coitus during the preovulatory period of the study. IUDs studied included Copper T 200 (4 women), Lippes loop (5 women), and progestin IUDs (5 women). Microscopic features indicative of normal preimplantation development were observed in 50% of the ova from control subjects but in 0% of the ova recovered from IUC users. Sixty-four percent of the eggs recovered from the IUC group showed no signs of development, as did 15% of the eggs recovered from the control group. Reference Alvarez F, Brache V, Fernandez E. New insights on the mode of action of intrauterine contraceptive devices in women. Fertil Steril. 1988;49(5): --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). *IUDs studied included Copper T 200 (4 women), Lippes loop (5 women), and progestin IUDs (5 women) Alvarez F. Fertil Steril

111 IUC Efficacy Is Comparable to Sterilization
[Insert Lecture Name Here] IUC Efficacy Is Comparable to Sterilization 5-year gross cumulative failure rate Cu T 380 1.4 All sterilization 1.3 Postpartum salpingectomy 0.5 Talking Points Because the failure rate for IUC is comparable to that for sterilization, IUC could be viewed in this context as reversible sterilization, not just reversible contraception. References World Health Organization. Mechanism of Action, Safety, and Efficacy of Intrauterine Devices. Technical Report Series 753. Geneva: WHO; 1987. Peterson HB, Xia Z, Hughes JM, et al. The risk of pregnancy after tubal sterilization: findings from the U.S. Collaborative Review of Sterilization. Am J Obstet Gynecol. 1996;174(4): --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). WHO. 1987; Peterson HB. Am J Obstet Gynecol

112 Discontinuation and Continuation Rates per 100 Women
Event LNG 52 IUS LNG 13.5 IUS 1 Year 5 Years 1 Year and 3 Years* Pregnancy 0.1 0.3 0.4 (1 year) 0.9 (3 year) Bleeding 5.8 10.9 4.6 Device expulsion 3.4 4.9 3.2 Pain (not further specified) 1.6 4.2 Pain, abdominal 2.5 Pain, pelvic 1.8 Continuation 80 47 82 Talking Points A 1994 Scandinavian study of a copper-releasing IUD (Nova T) and an LNG-releasing (20 μg/24 h) IUD (i.e., LNG 52 IUS) included 1,821 women who used the LNG 52 IUS. Premature discontinuations due to adverse events and continuation rates are shown in this table. Two clinical trials of LNG 13.5 IUS (SkylaTM) enrolled 1,672 patients, including 1,383 who used the contraceptive for 1 year and 993 who completed a 3-year study. The women were healthy, ages years, and predominantly Caucasian (83%). Eighteen percent discontinued due to an adverse event. The most common adverse events leading to discontinuation are shown in this table. These are the combined results from the 1- and 3-year studies, with the exception of pregnancy results. References Andersson K, Odlind V, Rybo G. Levonorgestrel-releasing and copper-releasing (Nova T) IUDs during five years of use: a randomized comparative trial. Contraception 1994;49(1):56-72. SkylaTM Prescribing Information. Wayne, NJ: Bayer HealthCare Pharmaceuticals. Available at Retrieved April 15, 2013. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). *Combined data; 1,383 patients for 1 year, 993 for 3 years

113 Safety: Rate of PID by Duration of IUC Use
[Insert Lecture Name Here] Safety: Rate of PID by Duration of IUC Use N = 20,000 women Talking Points Longer duration of IUC use is associated with a lower rate of PID. Among approximately 20,000 women who used an IUD for 21 days to 8 years, the incidence of PID was approximately 1 per 1,000 woman-years, compared with a rate of nearly 10 in 1,000 woman-years among women who used IUC for 20 days or fewer. Reference Farley T, Rowe P, Meirik O, et al. Intrauterine devices and pelvic inflammatory disease: an international perspective. Lancet. 1992;339(8796):785-8. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Farley T. Lancet

114 Safety: IUC 5-Year Cumulative Gross Removal Rate for PID
[Insert Lecture Name Here] Safety: IUC 5-Year Cumulative Gross Removal Rate for PID Per 100 women Nova-T LNG 52 Talking Points In this open, randomized, comparative, multicenter, Scandinavian trial by Andersson et al. (N = 2,758), women received either a Copper T IUD (Nova T) or LNG 52 IUS. No increase in PID was seen in relation to the insertion. This may be due to protocol and training criteria, which included the requirement that cervicitis be excluded before insertion and aseptic technique be used at insertion. Reference Andersson K, Odlind V, Rybo G. Levonorgestrel-releasing and copper-releasing (Nova T) IUDs during five years of use: a randomized comparative trial. Contraception 1994;49(1):56-72. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Andersson K. Contraception

115 Safety: IUC Does Not Cause Infertility
[Insert Lecture Name Here] Safety: IUC Does Not Cause Infertility IUC is not related to infertility Chlamydia is related to infertility Tubal infertility by previous Copper T IUD use and presence of chlamydia antibodies, nulligravid women Talking Points Background: Previous studies of IUDs, many of which are no longer in use, suggested that copper IUDs might cause tubal infertility, decreasing the use of this method in nulligravid women. Hubacher et al. enrolled 1,895 women in a case-control study: 358 women with primary infertility with tubal occlusion documented by hysterosalpingogram, 953 women who were infertile without tubal occlusion (infertile controls), and 584 primigravid women (pregnant controls). Information was obtained about the women’s past use of contraceptives, including copper IUDs; previous sexual relationships; and history of STIs. Each subject had antibody testing for Chlamydia trachomatis. Stratified analysis and logistic regression analyses were employed. Results: Odds ratio for tubal occlusion associated with previous use of a copper IUD: 1.0 (95% CI, 0.6–1.7) using infertile controls. When the primigravid women served as controls, the odds ratio was 0.9 (95% CI, 0.5–1.6). Odds ratio for tubal occlusion associated with chlamydia was 2.4 (95% CI, 1.7–3.2). Conclusions: Previous use of a copper IUD is not associated with increased risk of tubal occlusion among nulligravid women; rather, chlamydial infection is. These results have been confirmed by others: Hov GG, Skjeldestad FE, Hilstad T. Use of IUC and subsequent fertility: Follow-up after participation in a randomized clinical trial. Contraception. 2007;75(2):88-92. Skjeldestad F, Bratt H. Fertility after complicated and non-complicated use of IUCs. A controlled prospective study. Adv Contracept. 1988;4(3): Wilson JC. A prospective New Zealand study of fertility after removal of copper intrauterine contraceptive devices for conception and because of complications: A four-year study. Am J Obstet Gynecol. 1989;160(2):391-6. Reference Hubacher D, Lara-Ricalde R, Taylor D, et al. Use of copper intrauterine devices and the risk of tubal infertility among nulligravid women. N Engl J Med. 2001;345(8):561-7. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Hubacher D. N Engl J Med

116 Safety: IUC May Be Used by HIV- Positive Women
[Insert Lecture Name Here] Safety: IUC May Be Used by HIV- Positive Women No increased risk of complications compared with HIV-negative women No increased cervical viral shedding WHO and CDC Category 2 rating Talking Points A 1999 study in Kenya found that copper IUD insertion did not significantly change the shedding of HIV-infected cervical cells. WHO and CDC give both the Copper T and the LNG IUS a Category 2 medical eligibility rating, suggesting that for women with HIV infection, the benefit of using an effective contraceptive method outweighs the potential risk of infection. Category 1: A condition for which there is no restriction for the use of the contraceptive method. Category 2: A condition where the advantages of using the method generally outweigh the theoretical or proven risks. Category 3: A condition in which the theoretical or proven risks usually outweigh the advantages of the method. Category 4: A condition which represents unacceptable health risk if the method is used (i.e., contraindications). References World Health Organization. Medical Eligibility Criteria for Contraceptive Use. 4th ed. Geneva: WHO; 2009. Centers for Disease Control and Prevention. United States Medical Eligibility Criteria for Contraceptive Use. MMWR Recomm Rep. 2010;59(RR04);52-63. Morrison CS, Sekadde-Kigondu C, Miller WC. Is the intrauterine device appropriate contraception for HIV-infected women? Br J Obstet Gynaecol. 2001;108(8): Richardson B, Morrison C, Sekadde-Kigondu C. Effect of intrauterine device use on cervical shedding of HIV-1 DNA. AIDS. 1999;13(15): --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). WHO. 2009; CDC. MMWR Recomm Rep. 2010; Morrison CS. Br J Obstet Gynaecol. 2001; Richardson B. AIDS

117 Safety: IUC May Be Used in Nulligravid Women
[Insert Lecture Name Here] Safety: IUC May Be Used in Nulligravid Women No evidence of increased infertility in nulliparous users of IUC Risk of PID and subsequent infertility is dependent on non-IUC factors Talking Points The data are also reassuring that IUC use does not increase the risk of infertility in nulliparous women. The risk of PID and subsequent infertility is dependent on non-IUC factors (e.g., a woman’s exposure to STIs). References World Health Organization. Medical Eligibility Criteria for Contraceptive Use. 4th ed. Geneva: WHO; 2009. Hubacher D, Lara-Ricalde R, Taylor D, et al. Use of copper intrauterine devices and the risk of tubal infertility among nulligravid women. N Engl J Med. 2001;345(8):561-7. Delbarge W, Batar I, Bafort M, et al. Return to fertility in nulliparous and parous women after removal of the GyneFix intrauterine contraceptive system. Eur J Contracept Reprod Health Care. 2002;7(1):24-30. Hov GG, Skjeldestad FE, Hilstad T. Use of IUD and subsequent fertility—follow-up after participation in a randomized clinical trial. Contraception. 2007;75(2):88-92. Penney G, Brechin S, de Souza A, et al. FFPRHC Guidance (January 2004). The copper intrauterine device as long-term contraception. J Fam Plann Reprod Health Care. 2004;30(1):29-42. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). WHO. 2009; Hubacher D. N Engl J Med. 2001; Delbarge W. Eur J Contracept Reprod Health Care. 2002; Hov GG. Contraception. 2007; Penney G. J Fam Plann Reprod Health Care

118 Nulligravid Adolescent: Practice Tips (continued)
Os finder Uterine dilators Timing of Insertion algorithm Talking Points An os finder can be used to locate the cervical opening, especially if the cervical os is very small. Uterine dilators may be useful to enlarge the cervical opening prior to insertion. Reference Westhoff C, Kernsa J, Morronia C, et al. Quick Start: a novel oral contraceptive initiation method. Contraception. 2002;66(3):141-5. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). more… Westhoff C. Contraception

119 Pain Decreases with Time After Insertion
Talking Points In a secondary analysis of a large, prospective study, the percentage of 1,947 women reporting pain after insertion of a Copper T IUD decreased over time. When measured at more than 39 weeks after insertion, pain rates had dropped to almost half of the initial proportion. Reference Hubacher D, Chen P-L, Park S. Side effects from the copper IUD: do they decrease over time? Contraception 2009;79(5):356–362. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Hubacher D. Contraception

120 [Insert Lecture Name Here]
Young Pregnant Women Need More Counseling About IUC Safety and Efficacy How safe/effective is IUC compared with pills, injections, or tubal sterilization? Unsure of safety Unsure of efficacy 71% 58% Talking Points A study of 190 women ages 14–25 presenting for prenatal or abortion care inquired about contraceptive history, plans, and knowledge. The majority of subjects wanted to postpone another pregnancy for 4 or more years and wanted a safe and effective method of contraception to reach this goal. The women were 20 years old on average; 27% had education past high school, and 47% had delivered a child. Ninety-one percent had not planned their current pregnancy. Fifty percent had heard of IUC, 71% did not know about its safety, and 58% did not know about its efficacy. Respondents who knew of IUC were older (21 vs. 19 years; P < 0.001) and more likely to be parous (55% vs. 39%; P = 0.04). The study suggests that “young women choosing contraception after a pregnancy would benefit from counseling about the relative safety and efficacy of IUC, allowing them to make fully informed contraceptive choices.” Reference Stanwood NL, Bradley KA. Young pregnant women’s knowledge of modern intrauterine devices. Obstet Gynecol ;108(6): --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Stanwood NL. Obstet Gynecol

121 What Do Women Find Unacceptable About IUC?
[Insert Lecture Name Here] What Do Women Find Unacceptable About IUC? Lack of objective information Reported side effects Anxiety about IUD insertion Infection risk Lack of personal control of IUC after insertion Talking Points In a British study, structured interviews were conducted with 10 women of various ages and parity who had never used IUC but had used contraception in the past 6 months. The study found five main themes that make women IUC non-users: Lack of objective information about IUC Reported side effects Anxiety about IUD insertion (including worries about mess and embarrassment during the fitting) Risk of infection Lack of personal control of IUC once the device is inserted (i.e., concern that the “hidden” nature of IUC might mean that it is unreliable) Reference Asker C, Stokes-Lampard H, Beavan J, et al. What is it about intrauterine devices that women find unacceptable? Factors that make women non-users: a qualitative study. J Fam Plann Reprod Health Care. 2006;32(2):89-94. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Asker C. J Fam Plann Reprod Health Care

122 [Insert Lecture Name Here]
IUC Is Cost Effective Higher one-time startup cost, but incurs substantially lower cost over time Both IUC manufacturers offer patient payment plan options Bulk discounts are available to clinicians Talking Points Compared with no method of contraception, every method of birth control achieves major savings. Over time, IUC is more cost effective than other forms of contraception. Other methods require more staff time and follow-up visits over time compared with the length of time each method will protect a woman. Discount programs and costs for IUC vary by state. References Darney P. Time to pardon the IUD? N Engl J Med. 2001;345(8): Trussell J, Leveque JA, Koenig JD, et al. The economic value of contraception: a comparison of 15 methods. Am J Public Health. 1995;85(4): Chiou CF, Trussell J, Reyes E, et al. Economic analysis of contraceptives for women. Contraception. 2003;68(1):3-10. --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC). Darney P. NEJM. 2001; Trussell J. Am J Public Health. 1995; Chiou CF. Contraception

123 IUC Side Effects vs. Complications
[Insert Lecture Name Here] IUC Side Effects vs. Complications Side Effects Menstrual effects Complications Infection Perforation Pregnancy Expulsion Missing threads Talking Points Menstrual effects Copper T IUD increases the duration and amount of menstrual flow. LNG IUC reduces flow, often leading to amenorrhea. Possible complications Infection Perforation Pregnancy Expulsion Missing threads --- Original content for this slide submitted by ARHP’s Clinical Advisory Committee for A Clinical Update on Intrauterine Contraception in March Original funding received from Bayer HealthCare Pharmaceuticals through an educational grant. This slide was updated in April Updates to this slide were made possible by funding received from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals through an educational grant. These slides are available through a collaboration between ARHP, the Curricula Organizer for Reproductive Health Education (CORE), and Medical Students for Choice (MSFC).


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