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Provider Education and Training to Increase Use of Intrauterine Contraception Association of Reproductive Health Professionals

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Presentation on theme: "Provider Education and Training to Increase Use of Intrauterine Contraception Association of Reproductive Health Professionals"— Presentation transcript:

1 Provider Education and Training to Increase Use of Intrauterine Contraception Association of Reproductive Health Professionals

2 Acknowledgment This program was made possible through educational grants from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals.

3 Disclosure Declarations NameDisclosure 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)Nothing to disclose. Aleya Horn Kennedy, MPP (Planner) Nothing to disclose. Beth Jordan Mynett, MD (Planner)Nothing to disclose. Amy Swann, MA (Planner) Nothing to disclose.

4 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 more…

5 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

6 Terms for Intrauterine Contraception IUCIUDIUS

7 6.8 MILLION PREGNANCIES over one year Unintended Pregnancy in the US Unintended: 49% Unintended births Elective abortions Fetal losses Intended: 51% 51% 23% 21% 5% Finer LB. Contraception. 2011; Finer LB. Fertil Steril. 2012; Finer LB. Perspect Sex Reprod Health. 2006; Henshaw SK. Fam Plann Perspect. 1998.

8 Presentation Outline 1.Contraceptive Use Globally and in the United States 2.Overview of Current IUC Methods 3.Patient Screening and Counseling for IUC ▪ Case presentations 4.IUC Insertion and Management 5.Hands-on Practicum

9 Contraceptive Use Globally and in the United States

10 Worldwide Use of IUC Use for Married Women of Reproductive Age Asia % Using IUCs EuropeLatin America & Caribbean AfricaOceania North America Population Reference Bureau. 2002; Mosher WD. Vital Health Stat. 2010.

11 History of Successful IUC Use 1909: Grafenberg develops ring- shaped IUC device 1962: First international conference on IUC; designs for plastic spiral and plastic loop presented 1967: T-shaped device developed 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. 2004. 1968: Contraceptive action of intrauterine copper reported 1976: Copper T 200 becomes first copper IUD 1980: LNG IUC tested in randomized clinical trials 1988: Copper T 380 IUD available in the United States 2001: LNG 52 IUS available in the United States 2013: LNG 13.5 IUS available in the United States

12 Need for Effective Reversible Methods 1 in 520% pregnancies ends in abortion of women selecting sterilization at age 30 years or younger express regret later Finer LB. Perspect Sexual Reprod Health. 2003; Stanwood NL. Obstet Gynecol. 2002; Hillis SD. Obstet Gynecol. 1999. There is a need for effective contraceptive methods that are “forgettable”

13 Why an Update on IUC? Myths exist about IUC Selection of candidates is unduly restrictive Misinformation about IUC among providers and patients is common Stanwood NL. Obstet Gynecol. 2002; Weiss E. Contraception. 2003.

14 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 Stanwood NL. Obstet Gynecol. 2002; Steinauer JE. Fam Plann Perspect. 1997; Weir E. CMAJ. 2003.

15 Use of IUC by Female Ob/Gyns vs. All Women in the United States Female Ob/Gyn Physicians General Population Population Reference Bureau. 2002; The Gallup Organization. 2004. % Using IUC

16 Considerations in Choice of Contraceptive Methods Effectiveness Side effects Convenience Duration of action and childbearing plans Patient choice Reversibility Non-contraceptive benefits Cost Privacy

17 Overview of Current IUC Methods

18 Characteristics of IUC Highest patient satisfaction among methods Rapid return of fertility Safe Immediately effective Long-term protection Highly effective 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. 1996.

19 Dispelling Myths About IUC 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 In fact, IUDs: 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. 2009.

20 IUC Available in the United States ParaGard ® PI. 2013; Teva. 2013. more… Copper T 380A IUD ▪ Copper ions ▪ Approved for 10 years of use

21 IUC Available in the United States (continued) Mirena ® PI. 2013; Skyla TM PI. 2013. 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

22 Mechanism of Action Copper T IUDLNG 52 IUSLNG 13.5 IUS PrimaryPrevents fertilization Reduces sperm motility and viability Inhibits development of ova Inhibits fertilization Causes cervical mucus to thicken Inhibits sperm motility and function SecondaryInhibits implantation IUC Mechanism of Action 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. 1986.

23 Efficacy: First-Year Failure Rates of Selected Contraceptives (Typical Use) Trussell J. 2011; WHO. 1987; Peterson HB. Am J Obstet Gynecol. 1996. LNG IUS Copper T IUD Injectable (DMPA) Pills/patch/ring Condom—male Spermicides No contraception Sterilization—female Percent

24 Return to Fertility (Reversibility) Pregnancies (%) Months After Discontinuation 0 20 40 60 80 100 0 121824303642 IUC OC Diaphragm Other methods Vessey MP. Br Med J. 1983; Andersson K. Contraception. 1992; Belhadj H. Contraception. 1986.

25 Continuation Rates at 1 Year The Contraceptive Choice Project. 2013; Rosenstock JR. Obstet Gynecol. 2012; Peipert JF. Obstet Gynecol. 2011. 84% of Copper T IUD users 55% of Non-LARC* users 88% of LNG 52 IUS users *LARC = long-acting reversible contraception. Non-LARC methods include the contraceptive pill, patch, and ring. VS.

26 Potential Side Effects Silverberg SG. Int J Gynecol Pathol. 1986; Sivin I. Contraception. 1991; Hidalgo M. Contraception. 2002; Crosignani PG. Obstet Gynecol. 1997. Type Copper T: Heavier or prolonged menses LNG IUS: Gradual decrease in menstrual flow During insertion Variable pain and/or cramping Vasovagal reactions First few days Light bleeding Mild cramping During insertion Inter- menstrual cramping Cramping

27 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 √√√ 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. 2013.

28 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 Varma R. Eur J Obstet Gynecol Reprod Biol. 2006; Gupta B. Int J Gynecol Obstet. 2006; Backman T. Obstet Gynecol. 2005. *FDA-approved indication.

29 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.

30 Safety: Overview Recent data continue to demonstrate the safety of current methods of IUC. Hubacher D. N Engl J Med. 2001; Nelson AL. Obstet Gynecol Clin North Am. 2000; Meirik O. Obstet Gynecol. 2001.

31 Safety: Medical Eligibility Criteria for Contraceptive Use CategoryRisk Level 1Method 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. 4Method not to be used. CDC. MMWR Recomm Rep. 2010; WHO. 2009.

32 Safety: Medical Eligibility Criteria for Contraceptive Use (continued) ConditionQualifier for conditionLNG IUSCopper T IUD Diabetes mellitus Past gestational diabetes 11 Diabetes without vascular disease 21 Diabetes with end-organ damage or >20 years’ duration 21 Endometriosis 12 ObesityBMI >30 kg/m 2 11 Uterine fibroids IUC OK unless fibroids block insertion 11 CDC. MMWR Recomm Rep. 2010; WHO. 2009.

33 Safety: Medical Eligibility Criteria for Contraceptive Use (continued) ConditionQualifier for conditionLNG IUSCopper T IUD Postpartum, not breastfeeding >3 weeks postpartum 11 Postpartum IUD insertion (breastfeeding or not breastfeeding) <10 minutes after placenta delivery 21 10 minutes after placenta delivery to 4 weeks postpartum 22 >4 weeks postpartum 11 Postpartum & breastfeeding >1 month postpartum 11 Post-abortion First trimester 11 Second trimester 22 CDC. MMWR Recomm Rep. 2010; Goodman S. Contraception. 2008; Grimes DA. Cochrane Library. 2000; Pakarinen P. Contraception. 2003; WHO. 2009.

34 Safety: Medical Eligibility Criteria for Contraceptive Use (continued) ConditionQualifier for conditionLNG IUSCopper T IUD HIV infection High risk or HIV+ 22 AIDS (without drug interactions) 33 PID Past, with subsequent pregnancy 11 Past, without subsequent pregnancy 22 Current 44 STI Vaginitis/increased risk of STI 22 Very high risk of STI 33 Current gonorrhea, chlamydia, or purulent cervicitis 44 CDC. MMWR Recomm Rep. 2010; WHO. 2009.

35 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 Svensson L. JAMA. 1984; Sivin I. Contraception. 1991; Farley TM. Lancet. 1992; Andersson K. Contraception. 1994; Hubacher D. N Engl J Med. 2001.

36 Patient Screening and Counseling for IUC

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

38 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 100 women in 1 year Comparing Typical Effectiveness of Contraceptive Methods Trussell J. 2011; WHO. 2007. Chart adapted from WHO 2007.

39 Outcomes for Women Referred for Sterilization Smith RA. J Fam Plann Reprod Health Care. 2006. N = 100 women 15% did not attend clinic 54% had sterilization 29% chose alternative method

40 Appropriate Candidates for IUC Women of any reproductive age seeking long-term, highly effective contraception

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 Nulligravid women LNG 13.5 IUS Nulligravid women Women who want a lower- dose LNG IUD ParaGard ® PI. 2013; Mirena ® PI. 2013; Skyla TM PI. 2013.

42 Contraindications to IUC CDC. MMWR; 2010. WHO. 2009. 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 There are few contraindications to IUC use

43 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 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. 2006.

44 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 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 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) Deans EI. Contraception. 2009; Grimes DA. Lancet. 2000.

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 more… Clinical Pearl

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 more… Clinical Pearl 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. 2012.

49 Nulligravid Adolescent: Counseling Points Follow-up and side effect monitoring important Counsel regarding signs of of expulsion Encourage use of condoms with new partners Hubacher D. Contraception. 2007; Tomas A. J Pediatr Adolesc Gynecol. 2006; Grimes DA. Cochrane Database Syst Rev. 2006.

50 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. 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 Consider: Copper T IUD or LNG 13.5 IUS

52 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 Grimes D. Cochrane Libr. 2000; ParaGard ® PI. 2013; WHO. 1983.

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 Grimes DA. Cochrane Libr. 2000. Clinical Pearl

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

55 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 CDC. MMWR. 2011; WHO. 2009.

56 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 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 Consider: LNG 52 IUS Has tried OCs in the past, dislikes having to take a daily pill

58 Heavy Menstrual Bleeding: Clinical Considerations Evaluate for underlying cause of heavy bleeding Differential diagnoses: ▪ Coagulopathy ▪ Endometrial lesion, fibroid, or polyp ▪ Anovulation James AH. Am J Obstet Gynecol. 2009; Kingman CEC. Br J Obstet Gynaecol. 2004; Mansour D. Best Pract Res Clin Obstet Gynecol. 2007.

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

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

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 more… Consider: LNG 52 IUS Kaunitz AM. Contraception. 2007; WHO. 2009.

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 Kaunitz AM. Contraception. 2007; WHO. 2009.

63 Uterine Fibroids: Practice Tips for Obese Patients To determine fibroid size and location: Transvaginal ultrasound Use clinical judgment more… Clinical Pearl

64 Uterine Fibroids: Practice Tips for Obese Patients (continued) To visualize cervix: Clinical Pearl

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 Kaunitz AM. Contraception. 2007.

66 Case Presentation: Cervical Stenosis “Cathy,” 32-year-old G1P1 Medical history: ▪ Cervical stenosis after LEEP Seeking long-term, “forgettable” contraceptive method Consider: Copper T IUD, LNG 13.5 IUS, or LNG 52 IUS

67 Cervical Stenosis: Clinical Considerations Insertion difficulty Insertion pain

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) Güney M. Obstet Gynecol. 2006; Edelman AB. Contraception. 2011. Clinical Pearl

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

70 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 Penney G. J Fam Plann Reprod Health Care. 2004; Varila E. Fertil Steril. 2001; Peled Y. Menopause. 2007.

71 LNG 52 IUS Can Be Combined with Oral Estrogen During Menopause Boon J. Maturitas. 2003; Peled Y. Menopause. 2007; Suvanto-Luukkonen E. Fertil Steril. 1999. High intrauterine/low systemic progestin reduces vaginal bleeding while minimizing progestin side effects Endometrium remains in nonproliferative state with no hyperplasia

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 Peled Y. Menopause. 2007.

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

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

75 FOLLOW-UP What would be abnormal symptoms with this method? Tell me what you will do if you experience spotting that is bothering 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. BENEFITS Tell me about some of the benefits of this method.How will this method have a positive impact for you? “Teach-Back” Method

76 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 Penney G. J Fam Plann Reprod Health Care. 2004.

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

78 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 ARHP. Clinical Proceedings. 2004.

79 IUC Insertion and Management

80 Timing of Insertion for Copper T IUD First day of LMP:>5 days ago Insert IUD today Urine pregnancy test negative First instance of unprotected sex since LMP: ≤5 days ago >5 days agoNoneInsert IUD today Insert IUD within 5 days of next menses Insert IUD today CDC. MMWR. 2013; Hatcher RA. 2005.

81 Timing of Insertion for LNG IUS Insert LNG IUS today 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 Insert LNG IUS today Patient accepts pill/patch/ring Patient declines pill/patch/ring, uses barrier method instead 2 weeks later, pregnancy test is negative CDC. MMWR. 2013; Hatcher RA. 2005.

82 Timing of Insertion of IUDs TimingProsCons 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 Alvarez Pelavo J. Ginecol Obstet Mex. 1994; Hatcher RA. 2005; O’Hanley K. Contraception. 1992. more…

83 Timing of Insertion of IUDs (continued) TimingProsCons Cesarean delivery Convenience; low rate of expulsion Strings may not be visible or palpable at cervix PostplacentalConvenience Increased rate of expulsion (7%–15%) Alvarez Pelavo J, et al. Ginecol Obstet Mex. 1994.; O’Hanley K, et al. Contraception. 1992.

84 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 Trussell J. 2011; D’Souza RE. 2003.

85 Prophylactic Antibiotics Before Insertion 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. 2002. Antibiotics have not been shown to reduce risk of PID when given prophylactically

86 Signs of Possible Complications SymptomPossible 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 more…

87 Signs of Possible Complications (continued) SymptomPossible 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

88 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 CDC. MMWR. 2013.

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 ARHP. 2004.

90 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 Ronnerdag M. Contraception. 2007. more…

91 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 Ronnerdag M. Contraception. 2007.

92 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 Hubacher D. Contraception. 2007, 2009; Sivin I. Contraception. 2007.

93 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 WHO. 2009; CDC. MMWR. 2010.

94 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

95 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 Penney G. J Fam Plann Reprod Health Care. 2004; WHO. 2002.

96 Management of PID If PID is diagnosed: IUD removal may not be necessary Treat infection Recommendations to remove IUD are not evidence based Grimes D. Lancet. 2000.

97 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 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. 1987.

98 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

99 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 ParaGard ® PI. 2013; Mirena ® PI. 2013; Skyla TM PI. 2013; UK Family Planning Research Network. Br J Fam Plann. 1989; Foreman H. Obstet Gynecol. 1981; Atrash HK. 1994.

100 Risk of Fetal Abnormality IUC is extra-amniotic No increase in birth defects for Copper T IUD Atrash HK. 1994; Layde PM. Fertil Steril. 1979; Simpson JL. Res Front Fertil Regul. 1985.

101 Hands-on Practicum

102 Steps for Insertion: Technique Varies According to Product 1. Perform pelvic exam to assess size and position of uterus 2. Apply speculum, antiseptic, and tenaculum 3. Sound the uterus 4. Load the device 5. Place the device 6. Cut the threads 7. Add documentation to patient’s chart (string length, uterine device, lot number, etc.)


104 Animated Insertion: LNG 52 IUS

105 Animated Insertion: LNG 13.5 IUS

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

107 Resources Association of Reproductive Health Professionals ( WHO/CDC Medical Eligibility Criteria ▪ planning/9789241563888/en/index.html planning/9789241563888/en/index.html ▪ ncy/USMEC.htm) ncy/USMEC.htm Family Pact ( BEDSIDER (

108 Supplemental Slides: 109–123

109 LNG 52 IUS vs. OCs in Nulligravid Women: Discontinuation Rates Suhonen S. Contraception. 2004. Reason LNG 52 IUS discontinuation rate per 100 OC discontinuation rate per 100 Pain*6.660 Hormonal4.959.75 Bleeding2.520 Spotting01.25 Expulsion1.20NA Other medical2.131.09 *Statistically significant difference

110 Percentage of Women with Fertilized Eggs in Oviducts After Midcycle Coitus Group Normal development (%) No development (%) Abnormal development (%) Control (n = 20) 501535 IUC* (n = 14) 06436 Alvarez F. Fertil Steril. 1988. *IUDs studied included Copper T 200 (4 women), Lippes loop (5 women), and progestin IUDs (5 women)

111 IUC Efficacy Is Comparable to Sterilization 5-year gross cumulative failure rate WHO. 1987; Peterson HB. Am J Obstet Gynecol. 1996. Cu T 380 1.4 All sterilization 1.3 Postpartum salpingectomy 0.5

112 Discontinuation and Continuation Rates per 100 Women *Combined data; 1,383 patients for 1 year, 993 for 3 years EventLNG 52 IUSLNG 13.5 IUS 1 Year5 Years1 Year and 3 Years* Pregnancy0.10.30.4 (1 year) 0.9 (3 year) Bleeding5.810.94.6 Device expulsion3.44.93.2 Pain (not further specified) 1.64.2— Pain, abdominal——2.5 Pain, pelvic——1.8 Continuation804782

113 Safety: Rate of PID by Duration of IUC Use N =  20,000 women Farley T. Lancet. 1992.

114 Safety: IUC 5-Year Cumulative Gross Removal Rate for PID Per 100 women Andersson K. Contraception. 1994. LNG 52 Nova-T

115 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 Hubacher D. N Engl J Med. 2001.

116 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 WHO. 2009; CDC. MMWR Recomm Rep. 2010; Morrison CS. Br J Obstet Gynaecol. 2001; Richardson B. AIDS. 1999.

117 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 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. 2004.

118 Nulligravid Adolescent: Practice Tips (continued) Os finder Uterine dilators Timing of Insertion algorithm more… Westhoff C. Contraception. 2002.

119 Pain Decreases with Time After Insertion Hubacher D. Contraception. 2009.

120 Young Pregnant Women Need More Counseling About IUC Safety and Efficacy Stanwood NL. Obstet Gynecol. 2006. How safe/effective is IUC compared with pills, injections, or tubal sterilization? 71% 58% Unsure of safety Unsure of efficacy

121 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 Asker C. J Fam Plann Reprod Health Care. 2006.

122 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 Darney P. NEJM. 2001; Trussell J. Am J Public Health. 1995; Chiou CF. Contraception. 2003.

123 IUC Side Effects vs. Complications Side Effects Menstrual effects Complications Infection Perforation Pregnancy Expulsion Missing threads

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