Intrauterine Contraception; A Method That Will Prevail! IUC/EMB/PCB

Intrauterine Contraception; A Method That Will Prevail! IUC/EMB/PCB
Patty Cason, MS, FNP-BC UCLA School of Nursing

Disclosure Expert Input Forum HPV Vaccine; Merck
Speaker Merck; Gardasil, NuvaRing Trainer Merck; Nexplanon, Implanon Advisory board; ParaGard Teva Speaker & trainer; ParaGard Teva

Outline Attributes of LARC Methods Characteristics of the IUC’s
Reducing barriers to IUC use Management of side effects and complications Step-by step insertion Tips for difficult insertions

“Politically Correct” Terminology
Old name IUD: Intrauterine Device New names IUC: Intrauterine Contraception Applied to Cu-T380 (ParaGard®) Generic term for both types IUS: Intrauterine System Applied to LNG-IUC (Mirena®) Multiple terms reflect the history of intrauterine contraception: Intrauterine devices (IUCs) were first described by their shape and size, material composition or property, by inventor or manufacturer, i.e. Mazlin spring, framed IUC, Copper 7®, Lippes Loop. As the science and community of reproductive health developed, other terms were introduced to better describe the method. Levonorgestrel intrauterine system (LNG IUC) describes an IUC which delivers levonorgestrel to the endometrium enhancing its mechanism of action. Its developers felt that it was more than a device, but a two part system, the device and the levonorgestrel depository. Intrauterine Contraception (IUC) is the recently introduced term that better describes all forms of this method—the LNG IUC and the Copper T IUC. [Note to faculty: some faculty members have suggested that the terminology gets confusing within the slide set. If you find this to be the case when you are giving presentations, you may “search and replace” the term “IUC” with “IUC” throughout the slide set.]

The Case for LARC Methods
More than 1/3 of all U.S. women will have had an induced abortion by age 45 20% of women selecting sterilization at age < 30 years later express regret Need for effective contraceptive methods that are “forgettable” If current rates of unintended pregnancy were to continue, the U.S. would have the highest abortion rate in the developed world. These are, by definition, unintended pregnancies that could have been prevented with effective contraception. Many women selecting 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: Henshaw SK. Unintended pregnancy in the United States. Fam Plann Perspect 1998 Jan-Feb;30(1):24. Hillis SD, Marchbanks PA, Tylor LR, Peterson HB. Poststerilization regret: findings from the United States Collaborative Review of Sterilization. Obstet Gynecol 1999 Jun;93(6):889. Stanwood, NL, Garrett JM, Konrad TR. Obstetrician-Gynecologists and the Intrauterine Device: A Survey of Attitudes and Practice. Obstet Gynecol 2002;99: Henshaw. Fam Plann Perspect 1998 Hillis et al. Obstet Gynecol 1999 Stanwood, NL. Obstet Gynecol 2002

U.S. Pregnancies: Unintended vs. Intended
Slide 7 Intended 51% Unintended 49% Unintended births 22.5% Unintended pregnancy, which threatens the health of women, is a persistent, serious problem in the United States. To call unintended pregnancy an on-going epidemic just hints at the magnitude of the problem. Half of all pregnancies are unintended. Half of these end in elective abortion. This enormous rate of unintended pregnancies persists despite a number of contraceptive methods that have a failure rate of less than 1% in typical use. The only explanations are that women are not being adequately informed about the availability of effective contraceptive methods or women are not using effective methods consistently. The data suggest that there is an important failure of the interaction between health care providers and women to provide protection against unintended pregnancy. Elective Abortions 26.5% Henshaw: Fam Plann Perspect 1998;30:24-29.

Contraceptive Use During Month of Unintended Pregnancy
Slide 13 43% used contraception 5% consistent method use: method failure Many women with an unwanted pregnancy report that they used contraception in the month that they became pregnant. The proportion who make this claim is even higher among those who terminated pregnancy through elective abortion. Again, these data suggest that women are not selecting a highly effective method of contraception or that highly effective methods are not being used consistently. 52% did not use contraception Guttmacher Institute In Brief Series

What are LARC Methods? Long Acting Reversible Contraception
IUCs: LNG-IUC ,Cu-T380 Implants: Etonogestrel Implant Long term continuous protection 24/7/365 protection… for 3-10 years Do not require episodic patient initiative for use Not daily Not weekly Not monthly Not even every 12 weeks

Why LARC Methods? They are “forgettable”
Require just one motivational act The most effective reversible methods available Superior continuation rates Are among the safest contraceptive methods…very few US-MEC category 3 or 4 grades Highest patient satisfaction among methods No need to take time to refill prescriptions An alternative to surgical sterilization The most cost saving method of contraception

Contraceptive Efficacy
Top Tier: Most Effective Female/male sterilization; IUC, Implant Middle Tier: Effective DMPA, Oral Contraceptive (OC), Patch, Ring Bottom Tier: Less Effective Barriers, Spermicides, Behavioral methods

Contraceptive Effectiveness and Continuation Rates
Perfect Use Typical Use Continuation rate Implant (Implanon) 0.05 84% Male sterilization 0.10 0.15 100% IUC LNG-IUC (Mirena) Cu-T 380 (ParaGard) 0.2 0.6 0.8 80% 78% Female sterilization 0.5 DMPA 0.3 3.0 56% OCs, Patch, Ring 8.0 68% For methods that require the user to remember daily or do something at the time of intercourse, the most important determinant of success is consistent and correct use. Methods that require less of the user, such as IUC, Depo Provera, Norplant and Sterilization are minimally influenced by consistent use; they also have higher inherent efficacy. Source: Hatcher, RA et al; Contraceptive Technology 18th Edition, New York, Ardent: 2004. Hatcher, RA et al; Contraceptive Technology 19th Edition,: 2007

Cost savings per dollar expenditure by contraceptive method, Family PACT 2003
Foster, D. G. et al. Am J Public Health 2009;99:

Intrauterine Contraception in the U.S.
Copper T-380 LNG-IUC Mechanism Spermicidal effect of copper Thickening of cervical mucus Duration Up to 10 years Up to 5 years Efficacy 0.8 failures/hwy 0.2 failures/hwy Benefit No hormones Less bleeding Non-contraceptive use None Menorrhagia Menstrual pain Cost (retail) $598/568 $703

Client Choice of IUC Type
Copper T IUC Good method for women who don’t want hormonal contraception LNG IUC Good method for women who request less menstrual flow or who experience dysmenorrhea

Copper T IUC: Mechanism of Action
Primary mechanism is prevention of fertilization Reduce motility and viability of sperm Inhibit development of ova Inhibition of implantation is a secondary mechanism The exact mechanism of action of IUC 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 IUCs to act as emergency contraception. References: Alvarez F, Brache V, Fernandez E, et al. New insights on the mode of action of intrauterine contraceptive devices in women. Fertil Steril. 1988;49:768. 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. American College of Obstetricians and Gynecologists. Statement on Contraceptive Methods. Washington, DC: American College of Obstetricians and Gynecologists, July 1998. Alvarez F, Brache V, Fernandez E, et al. Fertil Steril. 1988;49:768 Segal SJ, Alvarez-Sanchez F, et al. Fertil Steril. 1985;44:214. ACOG. Statement on Contraceptive Methods, Washington DC:ACOG, July 1998 Rivera R, Yacobson I, Grimes D, Am J Obstet Gynecol 1999;181:1263-9 Stanford JB, Mikolajczyk RT, Am J Obstet Gynecol 2002; 187: Alvarez Fertil Steril. 1988; Segal. Fertil Steril ACOG. Statement on Contraceptive Methods. 1998

LNG-IUC Physical Characteristics
Steroid reservoir 32 mm Talking Points The product is as wide (32mm) as it is long with its arms fully extended. Small T shaped frame with a LNG containing cylinder. Potent progestin found in many combination oral contraceptive, progestin only pills, and implants. The LNG system releases LNG from the cylinder at 20 mcg per day into the uterine cavity for at least 5 years. Highly effective contraceptive protection. Published studies provide data on 12,000 women years of use . Two million women have used this method world-wide to date. levonorgestrel 20 g/day

LNG-IUC: Contraceptive Mechanism
Cervical mucus thickened Sperm motility and function inhibited Endometrium suppressed Ovulation inhibited (in some cycles) Talking Points The picture on the slide is just a schematic, so it is not anatomically proportional. The mechanism of action of the levonorgestrel intrauterine system is similar to that of LNG implants or LNG containing mini-pills. As with other methods, thickening of the cervical mucus (1), and inhibition of sperm motility and function are the primary role (2). The LNG intrauterine system does not usually inhibit ovulation (3), but the pregnancy rate and the ectopic rate are extremely low, suggesting that a primary endometrial effect as the mechanism of action is unlikely. The endometrial atrophy which is a consequence of the high endometrial levels of LNG leads to the substantial decrease in menstrual flow and absence of bleeding in some women noted in users of this form of intrauterine contraception. A weak foreign-body effect is also noted. It is important to some patients that the LNG IUC mechanisms of action are all pre-conception. They prevent fertilization rather than disrupt implantation (a common misconception). Source Jonsson B, Landgren B-M, Eneroth P. Effects of various IUCs on the composition of cervical mucus. Contraception 1991;43:447. Nilsson CG, Lahteenmaki PLA, Luukkainen T, et al. Ovarian function in amenorrheic and menstruating users of a levonorgestrel-releasing intrauterine device. Fertil Steril 1984;41:52. Videla-Rivero L, Etchepareborda J, Desseru E. Early chorionic activity in women bearing intert IUC, copper IUC and levonorgestrel-releasing IUC. Contraception 1987;36:217. Jonsson et al. Contraception 1991;43:447 Videla-Rivero et al. Contraception 1987;36:217 Rivera R, Yacobson I, Grimes D, Am J Obstet Gynecol 1999;181:1263-9 Stanford JB, Mikolajczyk RT, Am J Obstet Gynecol 2002; 187:

Plasma Concentrations of Levonorgestrel
Talking Points The graph on the slide is a schematic that contrasts the plasma concentrations of “bolus” administration of oral minipills and combined OCs with the sustained release of LNG that occurs in the IUC and the LNG implant. At this level of plasma concentration, ovarian hormonal function is maintained. About 85% of cycles are ovulatory at the end of one year, and estrogen levels are normal. As noted earlier, while plasma concentrations are low, endometrial concentrations are high. The effects of the hormone are thus targeted to where they are needed, not spread systemically. With the low dose LNG IUC, LNG is detected in the serum 15 minutes after insertion. After an initial higher concentration, LNG reaches a steady-state in several weeks. LNG IUC has a lower plasma concentration than implants. For short periods, combined OCs produce serum concentrations 50 times those of the low dose products. Source Diaz S, Pavez M, Miranda P, Johansson ED, Croxatto HB. Long-term follow-up of women treated with Norplant implants. Contraception 1987 Jun;35(6):551. Kuhnz W, al-Yacoub G, Fuhrmeister A. Pharmacokinetics of levonorgestrel and ethinylestradiol in 9 women who received a low-dose oral contraceptive over a treatment period of 3 months and, after a wash-out phase, a single oral administration of the same contraceptive formulation. Contraception 1992 Nov;46(5):455. Luukkainen T, Lahteenmaki P, Toivonen J. Levonorgestrel-releasing intrauterine device. Ann Med 1990;22:85-90. Nilsson C G, Lahteenmaki P, Robertson D N, Luukkainen T. Plasma concentrations of levonorgestrel as a function of the release rate of levonorgestrel from medicated intra-uterine devices. Acta Endocrinol 1980;93:380. Nilsson et al. Acta Endocrinol 1980;93:380 Diaz et al. Contraception 1987;35:551

Meta-Analysis: Mirena® vs. Ablation for Heavy Menstrual Bleeding
No difference between rates of treatment failures 21.2% LNG-IUC vs. 17.9% endometrial ablation Both resulted in similar improvements in quality of life Less need for analgesia/anesthesia in LNG-IUC group Ablation requires additional effective contraception Kaunitz, et al. OG May;113(5): b.

Why Aren’t They Used More Frequently in the US?
So….if IUCs are so good… Why Aren’t They Used More Frequently in the US?

Contraception by Age (2008)
Mosher WD. National Survey of Family Growth. Series 23, Number 29 August 2010

Increased Use of Intrauterine Contraception in California, 1997 to 2007
Modern intrauterine contraception is safe and highly effective, but is used by fewer than 4% of women in the United States. Previously recommended only for women with at least one child, now recommended for most women regardless of parity or age. 10 years of the California Women's Health Survey Womens Health Issues Jun 30. [Epub ahead of print] Increased Use of Intrauterine Contraception in California, 1997 to 2007. Thompson KM, Foster DG, Harper CC. Thompson KM, et al. Womens Health Issues. 2011

Use of IUC in California almost doubled over the study period from 4.0% to 7.2% Women with the greatest increases were: younger born in the US without a college degree Asian IUC use among nulliparous women did not increase and IUC users were 71% less likely to be nulliparous Womens Health Issues Jun 30. [Epub ahead of print] Increased Use of Intrauterine Contraception in California, 1997 to 2007. Thompson KM, Foster DG, Harper CC. Thompson KM, et al. Womens Health Issues. 2011

CONCLUSION: IUC use in California is higher than the national average and growing Disproportionately low use among nullips Efforts to inform women of IUC's effectiveness and safety, as well as efforts to ensure that health care providers have the necessary clinical skills, are timely and important. Womens Health Issues Jun 30. [Epub ahead of print] Increased Use of Intrauterine Contraception in California, 1997 to 2007. Thompson KM, Foster DG, Harper CC. Thompson KM, et al. Womens Health Issues. 2011

Why is the IUC Underutilized in the United States?
Dearth of trained and willing professionals to insert devices Negative publicity about method in ’70s Misconceptions by health care providers and the public Fear of litigation The majority of residents responding to a 1995 survey of program directors and chief residents at 244 family medicine residency programs in the United States reported they had no clinical experience in IUC insertion and removal. 31% of chief residents and 22% of program directors reported no oral instruction about IUCs. 43% of chief residents at family practice programs received no training on IUC insertion; 41% received no removal training. A mailed survey of 811 practicing ob/gyns (all ACOG members) shows that ob/gyns insert few IUCs because of myths about IUC safety and fear of litigation. References: Stanwood, NL, Garrett JM, Konrad TR. Obstetrician-Gynecologists and the Intrauterine Device: A Survey of Attitudes and Practice. Obstet Gynecol 2002;99: Steinauer JE, DePineres, T, Robert AM, Westfall J, Darney P. Training family practice residents in abortion and other reproductive health care: a nationwide survey. Family Planning Perspectives 1997;29:222-7. Weir E. Preventing pregnancy: a fresh look at the IUC. CMAJ. 2003;169(6):585. Weir. CMAJ 2003 Stanwood, NL. Obstet Gynecol 2002 Steinauer JE. Family Planning Perspectives 1997

Family PACT Provider Practices With IUCs
Survey of 1,246 providers with at least one IUC insertion claim in 2005; response rate 65% (n=813) Providers who think an IUC should not be inserted in clients if: Nulliparous: 50% Adolescent: 58% History of ectopic pregnancy: 63% Provider’s concern about PID affected willingness to recommend IUC “A lot” (29%) “Some” (61%) Family PACT Provider Practices With IUCs Harper C, et. al. OB GYN 2008; 111: 1359 Harper C, et. al. OB GYN 2008

IUC Use By Female Ob/Gyns vs. All Women in the U.S.
18% % of population This slide shows the likelihood of IUC use among female physicians (18%) v. general population (0.7%). 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. U.S. women’s perceptions of and attitudes about the IUC. Obstet Gynecol Surv Dec;51(12 Suppl):S30-4. 0.7% Female Ob/Gyn Physicians General Population Population Reference Bureau, 2002.; The Gallup Organization, 2004.

Dearth of trained and willing professionals to insert devices Misconceptions by health care providers and the public Negative publicity about method in ’70s Fear of litigation The majority of residents responding to a 1995 survey of program directors and chief residents at 244 family medicine residency programs in the United States reported they had no clinical experience in IUC insertion and removal. 31% of chief residents and 22% of program directors reported no oral instruction about IUCs. 43% of chief residents at family practice programs received no training on IUC insertion; 41% received no removal training. A mailed survey of 811 practicing ob/gyns (all ACOG members) shows that ob/gyns insert few IUCs because of myths about IUC safety and fear of litigation. References: Stanwood, NL, Garrett JM, Konrad TR. Obstetrician-Gynecologists and the Intrauterine Device: A Survey of Attitudes and Practice. Obstet Gynecol 2002;99: Steinauer JE, DePineres, T, Robert AM, Westfall J, Darney P. Training family practice residents in abortion and other reproductive health care: a nationwide survey. Family Planning Perspectives 1997;29:222-7. Weir E. Preventing pregnancy: a fresh look at the IUC. CMAJ. 2003;169(6):585. Weir. CMAJ 2003 Stanwood, NL. Obstet Gynecol 2002 Steinauer JE. Family Planning Perspectives 1997

Rate of PID by Duration of IUC Use
Rate per Woman-Years 20 days 21 days - 8 years Duration of Use n=20,000 women. Baseline PID risk: 1-2 cases /TWY Longer duration of IUC use is associated with a lower rate of pelvic inflammatory disease. Among approximately 20,000 women using the device for 21 days to 8 years, incidence of the disease was approximately 1 per 1000 woman-years, as opposed to a rate of nearly 10 in 1000 woman-years among women using the IUC for 20 days or less. Reference: Farley T, Rowe P, Meirik O, Rosenber MJ, Chen J-H. Intrauterine devices and pelvic inflammatory disease: an international perspective. Lancet 1992;339:1904. Adapted from Farley T, et al. Lancet. 1992;339:

[Insert Lecture Name Here]
IUCs Do Not Cause PID PID incidence for IUC users is similar to that of the general population Risk is increased only during the first month after insertion Preexisting STI at time of insertion, not the IUC itself, increases risk No reason to restrict use based on sexual behaviors Talking Point The presence of a preexisting sexually transmitted infection (STI) at time of insertion, not the IUC itself, increases the risk of PID. References Svensson L, Westrom L, Mardh PA. Contraceptives and acute salpingitis. JAMA. 1984;251(19): 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 IUCS. Contraception. 1991;44(5): Farley T, Rowe P, Meirik O, et al. Intrauterine devices and pelvic inflammatory disease: an international perspective. Lancet. 1992;339:1904. Grimes DA. Intrauterine device and upper-genital-tract infection. Lancet 2000;16:356:1013–9. Hubacher D, Lara-Ricalde R, Taylor DJ, Guerra-Infante F, Guzmán-Rodríguez R R. Use of copper intrauterine devices and the risk of tubal infertility among nulligravid women. N Engl J Med 2001;345:561–7 - - - Original content for this slide submitted by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in April Original funding received from Bayer HealthCare Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in May 2007. Svensson L, et al. JAMA Sivin I, et al. Contraception Farley T, et al. Lancet Grimes DA, Lancet 2000. Hubacher D, et al. Engl J Med 2001 Slide 30

Dearth of trained and willing professionals to insert devices Misconceptions by health care providers and the public Negative publicity about method in ’70s Fear of litigation The majority of residents responding to a 1995 survey of program directors and chief residents at 244 family medicine residency programs in the United States reported they had no clinical experience in IUC insertion and removal. 31% of chief residents and 22% of program directors reported no oral instruction about IUCs. 43% of chief residents at family practice programs received no training on IUC insertion; 41% received no removal training. A mailed survey of 811 practicing ob/gyns (all ACOG members) shows that ob/gyns insert few IUCs because of myths about IUC safety and fear of litigation. References: Stanwood, NL, Garrett JM, Konrad TR. Obstetrician-Gynecologists and the Intrauterine Device: A Survey of Attitudes and Practice. Obstet Gynecol 2002;99: Steinauer JE, DePineres, T, Robert AM, Westfall J, Darney P. Training family practice residents in abortion and other reproductive health care: a nationwide survey. Family Planning Perspectives 1997;29:222-7. Weir E. Preventing pregnancy: a fresh look at the IUC. CMAJ. 2003;169(6):585. Weir. CMAJ 2003 Stanwood, NL. Obstet Gynecol 2002 Steinauer JE. Family Planning Perspectives 1997

Dalkon Shield

Dalkon Shield- multi-filament string

Fertility Rates in Parous Women After Discontinuation of Contraceptive
[Insert Lecture Name Here] Fertility Rates in Parous Women After Discontinuation of Contraceptive Pregnancies (%) Months After Discontinuation 20 40 60 80 100 12 18 24 30 36 42 IUC OC Diaphragm Other methods Talking Point Research indicates that return of fertility after IUC removal is rapid, similar to that after 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 the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in April Original funding received from Bayer HealthCare Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in May 2007. Vessey MP, et al. Br Med J Andersson K, et al. Contraception Belhadj H, et al. Contraception Slide 34

Use of the levonorgestrel releasing-intrauterine system in nulliparous women
To evaluate the insertion procedure and continuation rates of the levonorgestrel releasing-intrauterine system (LNG-IUS) in nulliparous women who, due to fear of complications, are often denied this very effective contraceptive method. Eur J Contracept Reprod Health Care Apr;16(2): Use of the levonorgestrel releasing-intrauterine system in nulliparous women--a non-interventional study in Sweden. Marions L, Lövkvist L, Taube A, Johansson M, Dalvik H, Øverlie I Marions L, et al. Eur J Contracept Reprod Health Care. 2011

Use of the levonorgestrel releasing-intrauterine system in nulliparous women
The insertions were considered easy by 72% of inserters * Only 5% of pts were dissatisfied No perforations No pregnancies CONCLUSION: Our results support the current practice in Sweden of offering LNG-IUS routinely to nulliparous women Eur J Contracept Reprod Health Care Apr;16(2): Use of the levonorgestrel releasing-intrauterine system in nulliparous women--a non-interventional study in Sweden. Marions L, Lövkvist L, Taube A, Johansson M, Dalvik H, Øverlie I * mostly carried out by midwives Marions L, et al. Eur J Contracept Reprod Health Care. 2011

US Medical Eligibility Criteria
Category Definition Recommendation 1 No restriction in contraceptive use Use the method 2 Advantages generally outweigh theoretical or proven risks More than usual follow-up needed 3 Theoretical or proven risks outweigh advantages of the method Clinical judgment that this patient can safely use 4 The condition represents an unacceptable health risk if the method is used Do not use the method

Indications for IUC Use
Both IUC products Long term contraception in fertile women 2010 US Medical Eligibility Criteria Menarche to age 20 Category-2 Age 20 and older Category-1 Nulliparity Category-2 Parous Category-1

SFP on Nullips Lyus R, Lohr P, Prage S, Board of the Society of Family Planning. Use of the Mirena LNG-IUS and Paragard CuT380A intrauterine devices in nulliparous women. Contraception 2010;81:367–71

Both IUC Products: US MEC 2010
Managing Difficult IUC Cases Both IUC Products: US MEC 2010 Category 4 Category 3 Distorted uterine cavity Post-partum endometritis Post-abortion endometritis Malignant GTD or ↑ hCG Cervical/endometrial cancer Current GC/CT/purulent cervicitis/PID Initiate: 4; Continue: 2 Pelvic TB Initiate: 4; Continue: 3 Postpartum (48h-4 wk) Benign GTD with ↓ hCG Increased risk of STIs Initiate**: 2/3; Continue: 2 Clarification for initiation: If a woman has a very high individual likelihood of exposure to gonorrhoea or chlamydial infection, the condition is a Category 3. Evidence: Using an algorithm to classify STI risk status among IUD users, one study reported that 11% of high STI-risk women experienced IUD related complications compared with 5% of those not classified as high risk. Morrison CS et al. Use of sexually transmitted disease risk assessment algorithms for selection of intrauterine device candidates. Contraception, 1999, 59: ** very high individual risk of exposure to GC or Ct is 3 41

US Medical Eligibility Criteria 2010
Managing Difficult IUC Cases US Medical Eligibility Criteria 2010 Category 4 Category 3 LNG-IUS only Current breast cancer Breast cancer (> 5 yrs NED) Liver tumors, severe cirrhosis Current MI or angina Migraines with aura AIDS (ARV drug interactions) Complicated transplant Lupus with anti-PL antibody Copper IUC only Lupus with thrombocytopenia Clarification for initiation: If a woman has a very high individual likelihood of exposure to gonorrhea or chlamydial infection, the condition is a Category 3. Evidence: Using an algorithm to classify STI risk status among IUD users, one study reported that 11% of high STI-risk women experienced IUD related complications compared with 5% of those not classified as high risk. Morrison CS et al. Use of sexually transmitted disease risk assessment algorithms for selection of intrauterine device candidates. Contraception, 1999, 59: 42

Timing of Insertion of Intrauterine Contraception
[Insert Lecture Name Here] Timing of Insertion of Intrauterine Contraception Timing Pros Cons With menses Ensures patient not pregnant Scheduling Interim pregnancy Any time Convenience Low expulsion rate Must exclude pregnancy Emergency contraception (Cu T only) Pregnancy prevention Not cost effective if used only for EC Talking Points Intrauterine contraception can be inserted at any time during the menstrual cycle, as long as the provider is reasonably certain the woman is not pregnant. The practice of inserting intrauterine contraception only during menses is unnecessary and inconvenient for the patient. When the copper T is used as emergency contraception (off-label use), rule out existing pregnancy by history and HCG, if indicated. The LNG IUC should not be used as emergency contraception. References: Alvarez PJ. [IUC insertion during cesarean section and its most frequent complications]. Ginecol Obstet Mex. 1994;62:330-5. O’Hanley K, Huber DH. Postpartum IUCs: keys for success. Contraception. 1992;45: - - - Original content for this slide submitted by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in April Original funding received from Bayer HealthCare Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in May 2007. Alvarez PJ. Ginecol Obstet Mex O’Hanley K, et al. Contraception Slide 43

Copper T380A intrauterine device for emergency contraception: a prospective, multicentre, cohort clinical trial. Eighteen family planning clinics in China 1963 women requesting EC within 120 hours of unprotected intercourse. followed at 1, 3 and 12 months after insertion of CuT380A. No pregnancies occurred prior to or at the first follow-up visit, making CuT380A 100% effective as emergency contraception in this study. BJOG Sep;117(10): Epub 2010 Jul 7. Copper T380A intrauterine device for emergency contraception: a prospective, multicentre, cohort clinical trial. Wu S, Godfrey EM, Wojdyla D, Dong J, Cong J, Wang C, von Hertzen H Wu S, et al. BJOG 2010

Copper T380A intrauterine device for emergency contraception: a prospective, multicentre, cohort clinical trial. The pregnancy rate over the 12-month period was 0.23 per 100 women 1.5% women experienced a difficult IUD insertion requiring local anesthesia or prophylactic antibiotics. No uterine perforations occurred. The 12-month postinsertion continuation rate was 94.0 per 100 woman-years. CuT380A is a safe and effective method for emergency contraception. The advantages of CuT380A include its ability to provide effective, long-term contraception. BJOG Sep;117(10): Epub 2010 Jul 7. Copper T380A intrauterine device for emergency contraception: a prospective, multicentre, cohort clinical trial. Wu S, Godfrey EM, Wojdyla D, Dong J, Cong J, Wang C, von Hertzen H Wu S, et al. BJOG 2010

A survey of women obtaining EC: are they interested in using the Cu IUD?
34.0% of 941 said they would be interested in an EC method that was long term, highly effective and reversible. Interested women were not significantly different from non-interested women in relation to age, marital status, education, household income, gravidity, previous abortions, previous STIs or relationship status. 37.5% of those interested or 12.8% of all those surveyed would wait an hour, undergo a pelvic exam to get the method and would still want the method knowing it was an IUD. Only 12.3% of these women could also pay $350 or more for the device. Turok DK, Gurtcheff SE, Handley E, Simonsen SE, Sok C, North R, Frost C, Murphy PA. Contraception May;83(5): Epub 2010 Sep 29. Turok DK, et al. Contraception. 2011

A pilot study of the Copper T380A IUD and oral levonorgestrel for emergency contraception.
(60%) chose oral LNG and (40%) chose the copper IUD. Contraception Dec;82(6): Epub 2010 Jul 15. A pilot study of the Copper T380A IUD and oral levonorgestrel for emergency contraception. Turok DK, Gurtcheff SE, Handley E, Simonsen SE, Sok C, Murphy P. Turok DK, et al. Contraception. 2010

Postpartum IUC Insertion US MEC 2010
Vaginal delivery or C/S Breast-feeding or non-lactating LNG-IUS Cu-IUD <10 min after delivery of placenta 2 1 10 min after delivery of placenta to <4 wks >4 wks post partum Puerperal sepsis 4

How Is Postpartum IUC Placement Performed?
IUC placement after vaginal delivery Insert IUC within 10 minutes of placental delivery Use sponge forceps on cervical lip 2nd forceps to place IUC at uterine fundus Cut string flush with external cervical os Trim strings at postpartum visit

How Is Postpartum IUC Placement Performed?
IUC placement at of caesarean section After delivery of placenta Manually place IUC at fundus tuck strings thru cervix Repair uterus Trim strings at postpartum visit

IUC Use During Lactation
[Insert Lecture Name Here] IUC Use During Lactation Effectiveness not decreased No increased risk of uterine perforation Expulsion Decreased insertional pain Reduced rate of removal for bleeding and pain LNG comparable to copper T in breastfeeding parameters Talking Points: Chi et al. assessed copper T IUC 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. In this study, no cases of uterine perforation occurred in either group. A more recent study found that the LNG IUC is comparable to the copper T in rates of breastfeeding continuation, complete weaning, full breastfeeding, and partial breastfeeding and did not affect infant growth or development. 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: Manufacturer’s labeling. 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): Chi I-C, et al. Contraception. 1989 Shaamash AH, et al. Contraception Slide 51

Post Abortion IUC Insertion (WHO MEC, Cochrane Review)
No difference in complications for immediate versus delayed insertion of an IUC after abortion There were no differences in safety or expulsions after insertion of an LNG-IUC compared to Cu-IUC Expulsion slightly greater when inserted after a 2nd trimester vs. a 1st trimester abortion US Medical Eligibility Criteria 2010 First trimester abortion: USMEC-1 Second trimester abortion: USMEC-2 52

Excellent Time for IUC Insertion- Post Abortion
Most women ovulate by 21 days post abortion (range 8-37 days) This is true for 1st trimester, 2nd trimester, medical abortion and spontaneous abortion S. Sober, S. Ratcliffe, M.D. Creinin and C. Schreiber, Ovulation resumption after medical abortion with mifepristone and misoprostol, Contraception 82 (2010), p. 207 R.P. Marrs, D.A. Kletzky, W.F. Howard and D.R. Mishell Jr, Disappearance of human chorionic gonadotropin and resumption of ovulation following abortion, Am J Obstet Gynecol 135 (1979), pp. 731–736 M.L. Donnet, P.W. Howie, M. Marnie, W. Cooper and M. Lewis, Return of ovarian function following spontaneous abortion, Clin Endocrinol (Oxf) 33 (1990), pp. 13–20 I.T. Cameron and D.T. Baird, The return to ovulation following early abortion: a comparison between vacuum aspiration and prostaglandin, Acta Endocrinol (Copenh) 118 (1988), pp. 161–167 Sober S, et al. Contraception 2010 Donnet ML, et al. Clin Endocrinol (Oxf) 1990 Cameron IT, et al. Acta Endocrinol 1988 R.P. Marrs, et al. Am J Obstet Gynecol 1979

Excellent Time for IUC Insertion- Post Abortion
Of 1.3 million abortions annually in US, about half are repeat procedures 40% of women scheduled for delayed IUC insertion did not return for the procedure Immediate post-abortal IUC insertion is a safe, effective, practical, and underutilized intervention that can reduce repeat unintended pregnancy and repeat abortion by two-thirds A.M. Stanek, P.H. Bednarek, M.D. Nichols, J.T. Jensen and A.B. Edelman, Barriers associated with the failure to return for intrauterine device insertion following first-trimester abortion, Contraception 79 (2009), pp. 216–220. P Bednarek, et al N Engl J Med 2011; 364: M Cremer, et al Contraception 2011; 83: P Bednarek, et al N Engl J Med 2011; 364: M Cremer, et al Contraception 2011; 83: Stanek AM, et al. Contraception 2009

Why Do A Post-Abortion IUC Placement?
Advantages One procedure rather than two Less or no pain with insertion, since cervix is dilated Immediate protection Reduce repeat unintended pregnancy risk 2nd visit often delayed or doesn’t occur Disadvantages Slightly higher expulsion rate 2nd tri TAB: 3-10%, 1st trimester TAB: 5-6% No TAB: 1-4% Is the decision to use an IUC biased while pregnant? P Bednarek, et al N Engl J Med 2011; 364: M Cremer, et al Contraception 2011; 83:

Intrauterine device insertion after medical abortion
The day a woman presents for verification of a completed medical abortion may be an ideal time to insert intrauterine contraception 4.1% expulsions No diagnosed pelvic infections, pregnancies, or uterine perforations The continuation rate at 3 months was 80%. Contraception Jun;83(6): Epub 2010 Dec 3. Intrauterine device insertion after medical abortion. Betstadt SJ, Turok DK, Kapp N, Feng KT, Borgatta Betstadt SJ, et al.Contraception. 2011

Pre-IUC Insertion Screening
Evidence supports no routine screening tests CT, GC: if high risk sexual behaviors or < age 26 and due for annual screening CT Pregnancy test: only if pregnancy suspected Pap smear: only if due for a routine Pap Any indicated screening test can be done on the day of IUC insertion Sufrin C, Postlewaite D, Armstrong MA, Merchant M, Steinhauer Comparison of the Incidence of PID in IUD users by GC & CT screening stategies. Oral Abstract Contraception 2010;82:186 Secura G, Allsworth J, Madden T, Mullersman JL, Piepert J. The Contraceptive CHOICE Project: reducing barriers to long-acting reversible contraception Am J Obstet Gynecol 2010;203:115.e1-7. U.S. Preventive Services Task Force. Screening for chlamydial infection: U.S. Prevnetive Services Task Force recommendation statement. Ann Intern Med 2007;147:128–34. U.S. Preventive Services Task Force. Screening for gonorrhea: recommendation statement. Ann Fam Med 2005;3:263–7 Skjeldestad FE, Halvorsen LE, Kahn H, Nordbø SA, Saake K. IUD users in Norway are at low risk for genital C. trachomatis infection. Contraception 1996;54:209–12. Faúndes A, Telles E, Cristofoletti ML, Faúndes D, Castro S, Hardy E. The risk of inadvertent intrauterine device insertion in women carriers of endocervical Chlamydia trachomatis. Contraception 1998;58:105–9. Acta Obstet Gynecol Scand. 2009;88(3): Infection risk and intrauterine devices. Martínez F, López-Arregui E Intrauterine Contraceptives (IUCs), Family PACT Clinical Practice Alert Sufrin C, et al. Contraception 2010 Secura G, et al. Am J Obstet Gynecol 2010 Martínez F, et al. Acta Obstet Gynecol Scand. Faúndes A, et al.Contraception 1998

Pre-Insertion Guidelines
Prophylactic antibiotics No value for routine administration May reduce PID in high prevalence GC/CT sites Premedication NSAID minutes before insertion is common, but no effect on pain or discontinuation Consider paracervical block if history of cervical os or canal stenosis Grimes AD, Schulz K. Prophylactic antibiotics for intrauterine device insertion: a metaanalysis of the randomized controlled trials. Contraception 1999; 60: 57–63 Martínez F, et al. Acta Obstet Gynecol Scand. Lancet Apr 4;351(9108): Randomised controlled trial of prophylactic antibiotics before insertion of intrauterine devices. IUD Study Group. Walsh T, Grimes D, Frezieres R, Nelson A, Bernstein L, Coulson A, Bernstein G. 58

Is A Follow Up Visit Necessary?
Practices vary Two studies by WHO in Africa with non-medicated IUCs conclude that a follow-up visit is unnecessary Arguments Pro: Detect early asymptomatic expulsion Further counseling Medico-legal “standard of practice”? Arguments con: Almost all adverse events have symptoms Patient knows to return if string cannot be felt

Post-IUC Insertion Counseling
The client should return if String cannot be located (use barrier method) Symptoms of pregnancy Symptoms of infection Pain, deep dysparunia, fever, foul discharge Sudden unexplained pelvic pain occurs Excessively heavy bleeding Prepare the patient for the insertion procedure by explaining that, as with any pelvic procedure, a woman may feel some cramp-like discomfort. Reassure her that you will take care to minimize discomfort and that the insertion procedure is brief. Advise the patient to call the office afterward if she cannot locate the string; her menstrual period returns to its pre-insertion pattern of flow or duration; she notices symptoms suggesting pregnancy - nausea, breast tenderness, etc.; or if she experiences sudden onset of unexplained pelvic pain.

Ectopic pregnancy risk when contraception fails. A review.
Furlong LA, Ectopic pregnancy risk when contraception fails. A review. J Reprod Med Nov;47(11):881-5. Furlong , Reprod Med. 2002

IUC Removal Post Menopause?
Strings seen: remove No strings: weigh benefit vs. hazard of removal Tail-less IUC (e.g., stainless steel coil ring) does not require removal unless requested by the client

IUCs: Bleeding Days Per Month
6 Copper IUC 4 2 Talking Points Note the dramatic reduction in bleeding days that occurs with LNG IUC over time vis-à-vis the copper IUC. This is a substantial benefit for many women. Source Luukkainen T, Toivonen J. Progestin IUC - its benefit for women´s health. In Sitruk R, Bardin CW, eds. Contraception: Newer Pharmacological Agents, Devices, and Delivery Systems. New York: Marcel Dekker 1992;90. LNG-IUC 4 8 12 16 20 24 Months Luukkainen and Toivonen. 1992;90

LNG-IUC: “Resting State” Endometrium
Lower volume of menstrual bleeding Shorter, lighter menses Less iron deficiency anemia Therapeutic for menorrhagia Less dysmenorrhea Suppression of endometriosis, adenomyosis BUT… 3-6 months for full effect on the endometrium Spotting is common during this time

Menstrual Effects of IUCs: LNG-IUC
Hypomenorrhea; intermenstrual bleeding Management Exclude PID, pregnancy, coagulopathy Supplemental estradiol for 2-3 wks NSAID’s If persistent bleeding, check for anemia Remove IUC if abnormal bleeding is unacceptable to patient Evidence shows NSAIDs decrease intermenstrual bleeding in women using hormonal implants. Anecdotal reports indicate NSAIDs are also effective in reducing intermenstrual bleeding and heavy bleeding in IUC users.

Menstrual Effects of IUCs: Copper IUC
Heavier or longer menses (or dysmenorrhea) Exclude PID, pregnancy, coagulopathy NSAIDs prophylactically WITH FOOD Pre-emptive use for first 3 cycles Start before onset or with onset of menses for anti- prostaglandin effect Naproxen sodium 220mg x2 BID (max 1100mg/day) Ibuprofen mg TID (max 2400mg/day) If heavy or persistent bleeding, check for anemia Remove IUC if bleeding is unacceptable to patient Evidence shows NSAIDs decrease intermenstrual bleeding in women using hormonal implants. Anecdotal reports indicate NSAIDs are also effective in reducing intermenstrual bleeding and heavy bleeding in IUC users.

IUCs: Management of Cramping
[Insert Lecture Name Here] IUCs: 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 unacceptable to patient

Ms B: “I Faint Easily” Ms B is a 25 year old G0 P0 woman requesting IUC placement She states that she has had a number of fainting episodes in the past…most recently at the dentist and another during a HPV vaccine injection She has told her PCP about this problem…heart auscultation and an ECG were normal. Are there any special precautions for her IUC placement? 68

Lightheadedness and Syncope: Vasovagal Attack
Mechanism Due to bradycardia + peripheral vasodilation AKA: non-cardiogenic syncope, cervical shock Association with IUC insertion Syncope in 2% of insertions Convulsions in 1 per 2,000 insertions More likely with Pain with cervical manipulation Nulliparity Previous episodes of vaso-vagal fainting Dehydration or NPO

Prodromal symptoms Lightheadedness, diaphoresis, nausea, anxiety Prodromal physical signs Facial pallor, yawning, pupillary dilation Convulsive syncope occasionally follows faint Seizure-like movements Rapid recovery with little or no post-ictal state Followed by pallor, headache, weakness

Prevention Good hydration (electrolyte/ sports drink) Eat before insertion Isometric muscle tensing during procedure “Grip your hands together, then pull hard” “Squeeze your leg muscles as hard as you can” Management Continue isometric muscle tensing Elevate patient’s legs while remaining supine If HR remains <60 bpm or convulsive syncope, give atropine 0.4 mg IV push Grubb BP N Engl J Med :1004 Grubb BP N Engl J Med 2005

Lightheadedness and Syncope: Other Causes
Hyperventilation Due to low CO2 levels (respiratory alkalosis) Heart rate normal or tachycardia Treat with shallow breaths or re-breathing bag Local anesthetic toxicity (if cervical block) CNS: lightheadedness, restlessness, anxiety, tinnitus, tremor, twitch, perioral numbness, visual changes, seizure, respiratory arrest CV: bradycardia, arrythmia, hypotension 72

Bleeding from Tenaculum Site
Remove tenaculum slowly Apply pressure for at least 60 seconds Chemical cautery Silver nitrate Monsel’s solution Suturing very rarely is necessary

Sivin I, Stern J.Fertil Steril 1994
Managing Difficult IUC Cases IUC Complications Absolute risk Comment Perforation 1/1,000 Mostly benign Expulsion 1-6/100 Most are self-recognized Unsuccessful placement 9/ 100 6% when different device is used after unsuccessful attempt Pregnancy <1/HWY Minimal impact if removed early in pregnancy PID 1-2/TWY Same as gen’l population Sivin I, Stern J. Health during prolonged use of levonorgestrel 20 micrograms/d and the copper TCu 380Ag intrauterine contraceptive device: a multicenter study. International Committee for Contraception Research (ICCR). Fertil Steril 1994;61:70 HWY: per 100 women per year TWY: per 1,000 women per year Sivin I, Stern J.Fertil Steril 1994

Sivin I, Stern J.Fertil Steril 1994
Managing Difficult IUC Cases IUC Complications Absolute risk Comment Perforation 1/1,000 Mostly benign Expulsion 1-6/100 Most are self-recognized Unsuccessful placement 9/ 100 6% when different device is used after unsuccessful attempt Pregnancy <1/HWY Minimal impact if removed early in pregnancy PID 1-2/TWY Same as gen’l population Sivin I, Stern J.Fertil Steril 1994

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 more…

Signs of Possible Complications
[Insert Lecture Name Here] Signs of Possible Complications 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

Genital Tract Infections
If cervical or vaginal infection diagnosed IUC removal not necessary Treat infection Counsel re: prevention of STI transmission If PID diagnosed IUC removal usually not necessary Recommendations to remove IUC are not evidence-based Consider removal if no improvement hours after starting treatment Intrauterine contraception 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 intrauterine contraception is not necessary unless symptoms fail to improve within 72 hours of treatment initiation. References: Penney G, Brechin S, de Souza A, et al; Faculty of Family Planning and Reproductive Health Care Clinical Effectiveness Unit. Penney 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. Penney G. J Fam Plann Reprod Health Care. 2004 WHO. Selected Practice Recommendations for Contraceptive Use

Actinomyces-Like Organisms (ALO)
Actinomyces israelii has characteristics of both bacteria and fungus; part of GI flora May asymptomatically colonize the frame of the IUC, which in itself is not dangerous Very small percentage of women with IUC + actinomyces will develop pelvic actinomycosis Presentation is similar to severe PID Women with ALO on Pap smear Should be examined to exclude PID If none, don’t treat actinomyces or remove IUC

Uterine Perforation More likely to occur in relation to
Managing Difficult IUC Cases Uterine Perforation More likely to occur in relation to Posterior uterine position Extreme flexion Skill/experience of provider Insertion 2 days-4 weeks after childbirth Typical location is midline at uterine fundus…if so, perforation often is asymptomatic, benign Suspect if sounding is much deeper than expected Greater for post-partum insertions performed between 48 hours and 6 weeks post delivery. In a study of over 8,000 women, Caliskan found that IUD insertion up to 6 months postpartum increased the risk of uterine perforation. References: Grimes, et al. Cochrane Library, 2001, Issue 2. Markovitch O, Klein Z, Gidoni Y, Holzinger M, Beyth Y. Extrauterine mislocated IUD: is surgical removal mandatory? Contraception 2002;66:105-8. Caliskan E, Ozturk N, Bilbaz BO, Dilbaz S. Analysis of risk factors associated with uterine perforation by intrauterine devices. The European Journal of Contraception and Reproductive Health Care 2003;8: Harrison-Woolrych M, Ashton J, Coulter D. Uterine perforation on intrauterine device insertion: is the incidence higher than previously reported? Contraception 2003;67:53-6. Grimes, et al. Cochrane Library, 2001, Issue 2. Markovitch O, et al. Contraception 2002 Caliskan E, et al. The European Journal of Contraception and Reproductive Health Care 2003 Harrison-Woolrych M, et al. Contraception 2003; 80 80

Management of Uterine Perforation
Managing Difficult IUC Cases Management of Uterine Perforation If before insertion of IUC, stop procedure If during insertion of IUC, remove IUC Monitor for 30 min for excessive bleeding, pain Provide alternative method of contraception Can insert another device after next menses Greater for post-partum insertions performed between 48 hours and 6 weeks post delivery. In a study of over 8,000 women, Caliskan found that IUD insertion up to 6 months postpartum increased the risk of uterine perforation. References: Grimes, et al. Cochrane Library, 2001, Issue 2. Markovitch O, Klein Z, Gidoni Y, Holzinger M, Beyth Y. Extrauterine mislocated IUD: is surgical removal mandatory? Contraception 2002;66:105-8. Caliskan E, Ozturk N, Bilbaz BO, Dilbaz S. Analysis of risk factors associated with uterine perforation by intrauterine devices. The European Journal of Contraception and Reproductive Health Care 2003;8: Harrison-Woolrych M, Ashton J, Coulter D. Uterine perforation on intrauterine device insertion: is the incidence higher than previously reported? Contraception 2003;67:53-6. 81 81

Prevention of Uterine Perforation
Why sound the uterus at all? Determine the “pathway” to the fundus Preliminary dilation of the internal os Establish depth to fundus to set flange Ensure depth within 6-10 cm limits Bend sound to mimic uterine flexion Brace fingertips on speculum to achieve control of force while advancing the sound EMB device can be used instead of metal sound Open IUC package after sounding completed 82

IUC Expulsion Occurs in 1-10% IUC insertions within first year
Managing Difficult IUC Cases IUC Expulsion Occurs in 1-10% IUC insertions within first year Risk of expulsion related to Provider’s skill at fundal placement Age, parity, BMI,uterine configuration Time since insertion (↑ within first 6 mos) Timing of insertion (menses, postpartum, post-abortion) Asymptomatic expulsion often presents with an (unanticipated) pregnancy Partial expulsion may present with Pelvic pain, cramps, intermenstrual bleeding Pregnancy Risk of expulsion is greater when device is inserted more than minutes and less than 48 hours after delivery of the placenta. Reference: CDCMedical Eligibility Criteria for Contraceptive Use P Bednarek, et al N Engl J Med 2011; 364: M Cremer, et al Contraception 2011; 83: 83

Missing IUC String: Diagnosis
Possibilities… Expulsion, pregnancy, embedment, translocation Initial management Probe for strings in cervical canal Cytology brush to tease from canal Endocervical speculum or forceps Rule out pregnancy Prescribe back-up contraceptive method until intrauterine location is confirmed Options for probing cervical canal for string: Use endocervical brush or 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. Contraception Feb;83(2): Epub 2010 Aug 23. In-office retrieval of intrauterine contraceptive devices with missing strings. Prabhakaran S, Chuang A Prabhakaran S. et, al. Contraception.2011

Missing IUC String: Management
No IUC string in canal Pregnancy test negative Desires retention Desires removal OR + initial UTZ Attempt extraction UTZ KUB In Situ Absent Absent Absent Present Extracted KUB UTZ Embedded Not felt Op hysteroscopy Present Absent In Situ Absent Extracted Translocated Expelled Translocated

Missing IUC String: Treatment
In situ (intrauterine) placement: desires continuation Leave in place for remainder of IUC lifespan In situ placement: desires removal Use straight or “alligator” forcep, + simultaneous real time pelvic ultrasound Crochet hook best for circular IUCs; less helpful with T-shaped IUCs If unsuccessful, extract via operative hysteroscopy Translocation (IUC in peritoneal cavity) Extract via operative laparoscopy Options for probing cervical canal for string: Use endocervical brush or 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.

Pregnancy With IUC In Situ
Determine site of pregnancy (IUP or ectopic) If intrauterine pregnancy confirmed Termination planned: await procedure Continue pregnancy: remove IUC if strings visible Removal decreases risk of spontaneous abortion, premature delivery Retention of IUC (if strings not visible) Increase surveillance for SAB, pre-term birth No greater risk of birth defects (extra-amniotic) If pregnancy occurs with an IUC in place, it is necessary to determine whether the pregnancy is intrauterine or ectopic. If the IUC strings are visible, the IUC should be removed as early as possible in the first trimester. Studies indicate that spontaneous abortions are more common in women whose IUCs remain in place than in those whose IUCs are removed in the first trimester. Early IUC removal decreases risks of first-trimester spontaneous abortion, second-trimester spontaneous abortion, and premature delivery. If ectopic, IUC does not need to be removed. References: UK Family Planning Research Network. Br J Fam Plann. 1989;15:7. Foreman H, Stadel BV, Schlesselman S. Intrauterine device usage and fetal loss. Obstet Gynecol Dec;58(6): Atrash HK, et al. In: Proceedings from the Fourth International Conference on IUCs. 1994:76.

Family PACT IUC Policy: Purchase and Records
Managing Difficult IUC Cases Family PACT IUC Policy: Purchase and Records IUCs must be FDA-approved devices, labeled for US use, and obtained from FDA approved distributors Providers must record the lot number in the med record and keep a written or electronic log of all IUCs inserted for at least 3 years from insertion Maintain invoices > 3 years from date of invoice Patients must be provided with a record of the dates of insertion and expiration Key points: IUCs are ideally suited for women who desire long-term contraception, including women who have not been pregnant and women who are unable or unwilling to use a combined hormonal method of contraception. An IUC user has no greater risk of PID or tubal infertility than a woman who uses no method of contraception, other than a small transient increased risk of infection in the first few weeks of insertion. Women who currently do not have PID and do not engage in risky sexual behaviors are appropriate candidates for IUC use, regardless of age, parity, or a history of PID. Providers must include complete medical record documentation in a client’s medical record to support services claimed for reimbursement. Providers should keep a log or an electronic record of all IUCs inserted for at least three years from the insertion date including the client’s name, medical record number, date of insertion, type of IUC, and the lot number of the IUC. All IUCs inserted through the Family PACT Program must be FDA-approved devices, labeled for use in the United States and obtained from an appropriately registered, permitted, or licensed manufacturer, wholesaler, or distribute. Providers must maintain invoices for IUCs billed to Family PACT for at least three years in accordance with Title 22, California Code of Regulations (CCR), Code 51476(a). 88

Billing Instructions for IUCs Primary Diagnosis Codes
S401: Evaluation prior to initiation of the method, whether or not the IUC is inserted that day Use S401 when performing the insertion of the first IUC for this client S402: Maintain adherence and surveillance for a current user of an IUC, whether or not the client is new to the provider Use S402 when replacing an IUC with another of the same type or a different type Both insertion and removal may be billed on the same date of service

Billing Instructions for IUCs Insertion or Removal Procedures
CPT 58300: Insertion of IUC 58300-ZM: Insertion supplies Kit: X1522 (ParaGard) or X1532 (Mirena) E&C: contraceptive counseling visit Removal CPT 58301: Removal of IUC 58301-ZM: Removal supplies

IUC Complication Coverage
New Family PACT benefits for IUCs CPT-4 code 76857: Ultrasound, pelvic (nonobstetric) CPT-4 code 76830: Ultrasound, transvaginal Billing requirements for code are revised 3 codes billed in conjunction with primary diagnosis code S402 and secondary diagnosis code V45.51 (intrauterine contraceptive device). A Treatment Authorization Request is not required. S4032 will no longer be a valid Family PACT PDC effective for dates of service on or after June 1, 2011. Effective for dates of service on or after June 1, 2011, the following codes are new Family PACT benefits in connection with missing intrauterine contraceptives (IUCs): CPT-4 code 76857: Ultrasound, pelvic (nonobstetric), real time with image documentation; limited or follow-up CPT-4 code 76830: Ultrasound, transvaginal Additionally, billing requirements for code (radiologic examination, abdomen; single anteroposterior view) are revised. All three codes are reimbursable only when billed in conjunction with primary diagnosis code (PDC) S402 (IUC, maintain adherence and surveillance) and secondary diagnosis code V45.51 (intrauterine contraceptive device). A Treatment Authorization Request is not required. PDC S4032 will no longer be a valid Family PACT PDC effective for dates of service on or after June 1, 2011.

IUC Complication Coverage
IUC complications S403 Vaso-vagal episode S4031 Pelvic infection (secondary to IUC) S4032 “Missing” IUC- no longer a valid code S4033 Perforated or translocated IUC Covered complication services include Hysteroscopy, dilation and curettage Laparoscopy/ laparotomy All complication services must be approved by TAR Please consult familypact.org

IUC Insertion Practicum
Insertion of LNG-IUC Insertion of Cu-T IUC The “Difficult” IUC Insertion

Steps for IUC Insertion
Perform bimanual pelvic exam to determine anterior or retro- flexion Inspect cervix for mucopus Cleanse cervix with antiseptic Use of sterile gloves vs. “no-touch” technique Apply tenaculum Routine vs. selective local anesthetic injection Hold hand in palm-up position “Squeeze” closed; don’t “snap” ratchet Horizontal or vertical application (purchase) Routine vs. selective use of cervical block

Steps for IUC Insertion
Sound the uterus Purposes Determine the “pathway” to the fundus Preliminary dilation of the internal os Establish depth to fundus to set flange Ensure depth within 6-9 cm limits Bend sound to mimic uterine flexion Brace fingertips on speculum to achieve control of force while advancing the sound EMS* device can be used instead of metal sound EMS*: endometrial sampling

Mirena: The Inserter “Never let go of the Slider!!”

* Excerpted from package insert
Steps for Mirena Insertion* 1. Open sterile package 2. Release the threads 3. Make sure the slider is ….in the furthest position ….away from you 4. Check that the arms of the IUC are horizontal * Excerpted from package insert

Steps for Mirena Insertion*
Pull on both threads to draw IUC system into insertion tube Both knobs at ends of IUC arms are now within the inserter

7. Fix threads tightly into the cleft at near end of inserter shaft

8. Set upper edge of movable green flange to the depth of uterine sound

9. Hold slider with forefinger, or thumb, firmly in furthermost position Move inserter thru cervical canal until flange is about cm from cervix - allows sufficient space for IUC arms to open

11. While holding inserter steady, release arms of IUC by pulling slider back until it reaches the raised mark on inserter

12. Push inserter gently until flange touches cervix. The IUC should be in fundal position

13. Pull down on slider all the way; threads will uncleat automatically and release IUC system Double check that the strings are uncleated before withdrawing the inserter

14. Remove inserter and cut threads about 2 to 3 cm from cervix 15. Measure and record in patient’s chart 16. Have patient feel for IUC threads

* Excerpted from package insert
ParaGard Insertion* Load arms into inserter * Excerpted from package insert

ParaGard Insertion Load arms into inserter

ParaGard Insertion Advance insertion tube to fundus
Fundal resistance should be coincident with the marker reaching the exocervix

ParaGard Insertion Pull back on inserter tube while holding white rod steady to deposit IUC in cavity Most important step

ParaGard Insertion Push inserter tube until resistance to seat the arms of the IUC in the fundus

ParaGard Insertion Withdraw the white rod while holding inserter tube steady

ParaGard Insertion Optional
Slowly withdraw the inserter from the cervical canal Trim threads to 3-4 cm. Optional Repeat bimanual exam or perform ultrasound to check placement

IUC Insertion: Tricks of the Trade A Clinical Update on Intrauterine For pain management Oral NSAID Naproxen sodium mg Ibuprofen mg Instill lidocaine in uterine cavity with an endometrial sampler The sampler can be used instead of sound to measure depth of uterus Talking Points These tips from clinicians can assist with insertion. For a woman with a narrow cervical canal Prime the cervix with misoprostol 400 mcg a few hours before or the night before insertion For pain management Take an oral NSAID 400 mg PO by itself, or also Apply lidocaine to the uterine cavity with an endometrial sampler while advancing to the fundus With skill, the sampler also can be used instead of sound to measure the depth of the uterus - - - Original content for this slide submitted by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in April Original funding received from Bayer HealthCare Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in May 2007. more… Slide 113

IUC Insertion: Tricks of the Trade A Clinical Update on Intrauterine To visualize cervix Use large speculum If vaginal walls obscure cervix, cut off end of condom or finger of a glove and slip over metal speculum Get better light For women with narrow cervical canal Misoprostol 400 mcg SL 1+ hours before insertion Talking Points These tips from clinicians can assist with insertion. To visualize the cervix: Use a large speculum If vaginal walls obscure the cervix, cut off the end of a condom and slip it over the metal speculum or use vaginal lateral retractors Get better light - - - Original content for this slide submitted by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in April Original funding received from Bayer HealthCare Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in May 2007. Slide 114

Reduce expulsion rate by waiting for strings to be released from cleft before withdrawal
OBG Management | Vol. 21 No. 2 | February 2009

What Should I Do if the LNG-IUC Isn’t at the Fundus?
There can be significant migration of the LNG-IUC within the uterine cavity Fundal placement insures that the tail strings will be long enough to remove the device A device that settles within the lower uterine segment is still effective Removal of the device is necessary only if A portion of it protrudes from the cervix, or There is excessive cramping with a low-lying IUC OBG Management | Vol. 21 No. 2 | February 2009

What Should I Do if the Cu 380A Isn’t at the Fundus?
Fundal placement is necessary for optimal efficacy A copper IUC in the lower uterine segment is less effective Removal of the device and re-insertion of a new device at the fundus is necessary to insure efficacy Do not “push” a partially expelled or low lying device up to the fundus

Intervention Steps in the “Difficult IUC Insertion”
Use greater outward traction on the tenaculum to minimize canal-to-endometrial cavity angulation Place paracervical or intracervical block to relax cervical smooth muscle and reduce pain Use os finder device, if available Dilate internal os with metal dilators to #13F (4.1 mm) If unsuccessful, return at a later date with use of misoprostol cervical priming

Os Finder Device Pratt Dilators
Cervical Os Finders (Disposable Box/25) $ Cervical Os Finder Set (Reusable Set of 3) $ 69.00 Pratt Dilators

Paracervical Block Target is uterosacral ligaments
Inject at reflection of cervico-vaginal epithelium 2 (5, 7 o’cl) or 4 sites (4,5,7,8 o’cl) submucosally to depth of 5 mm Use spinal needle or 25g, 1 ½” needle + extender Moore-Graves speculum allows for more movement Tips Start with ½-1 cc. at tenaculum site Disguise pain of needle insertion with cough WAIT 1-2 minutes for set up before procedure

Paracervical Block X X X 7 o’clock 5 o’clock

Paracervical Block X X X X 5 o’clock 7 o’clock X 6 o’clock

Intra-cervical Block Targets the paracervical nerve plexus
1 ½ inch 25g needle with 12 cc “finger lock” syringe Inject ½- 1 cc. local anesthetic at 12 o’clock, then apply tenaculum Angulate needle at the hub to 45o lateral direction At 3 or 9, insert needle into cervix to the hub 1 cm lateral to external os, aspirate Inject 4 cc of local, then last 1 cc while withdrawing Rotate barrel 180o, then inject opposite side

Intracervical Block X X X 9 o’clock 3 o’clock 5 o’clock 7 o’clock

Effects of prophylactic misoprostol administration prior to intrauterine device insertion in nulliparous women Nulliparous women 400 mcg of buccal misoprostol or placebo 90 min prior to IUD insertion. No significant differences in patient-reported pain with IUD placement (misoprostol 65 mm , placebo 55 mm) at any other time point. The misoprostol group reported significantly more preinsertion nausea (29% vs. 5%) and cramping (47% vs. 16%) than the placebo group. While provider-reported ease of insertion was not significantly different between groups, three placebo patients required additional dilation vs. none in the misoprostol group. All 35 subjects underwent follow-up at least 1 month postinsertion, and no expulsions were reported. CONCLUSION: Prophylactic misoprostol prior to IUD placement in nulliparous women did not reduce patient perceived pain, but it did appear to increase preinsertion side effects. Contraception Sep;84(3): Epub 2011 Mar 3. Effects of prophylactic misoprostol administration prior to intrauterine device insertion in nulliparous women. Edelman AB, Schaefer E, Olson A, Van Houten L, Bednarek P, Leclair C, Jensen JT. Edelman AB, et al. Contraception. 2011

80 nulliparas treated 1 hour prior to IUD insertion
Misoprostol 400 mcg SL and diclofenac 100 mg Diclofenac 100 mg PO alone (control group) Findings Insertion considered easier by the provider with misoprostol than control group Pt pain scores no different in the two groups Most side effects equal Shivering, diarrhea more common in misoprostol group Saav I et. al., Human Reproduction 2007; 22, (10): 2647 126

Misoprostol for IUC Insertion
Conclusion Misoprostol facilitates IUD insertion and reduces the number of difficult and failed attempts of insertions in women with a narrow cervical canal 127 Saav I et. al., Human Reproduction 2007; 22, (10): 2647

Prophylactic misoprostol prior to IUD insertion in nulliparous women
RCT, nulliparous women, 18–45 years old MPL 400 mcg bucally or placebo 90 min prior 36 women completed the study Findings MPL group a trend toward a more painful insertion Ease of placement was no different between groups MPL group had more pre-insertion nausea and cramping than the placebo group (50% vs. 16%) No reported expulsions Prophylactic misoprostol prior to IUD insertion in nulliparous women Shaefer E et al, Contraception 2010; 82(2):188 Shaefer E et al, Contraception 2010

Misoprostol for IUC Placement Take It Home
Misoprostol works well to soften and dilate the cervix in pregnant women Studies in non pregnant women having GYN procedures (hysteroscopy, EMB ) have mixed results MPL prior to IUC placement is often recommended But Little evidence to support a clear benefit of this practice Some evidence that it may be harmful It should not be accepted as a “standard practice” yet

Ms D: “I Have Fibroids” Ms D is a 35 year old G0 P0 woman who is seen for contraceptive counseling Over the past 2 years, her periods have been heavier and longer than previously Bimanual exam: Irregular 12 week size uterus LNG-IUS chosen for contraception and bleeding control Clinical dilemmas… LNG-IUS control of fibroid-related bleeding Technical IUC insertion issues with uterine fibroids

LNG-IUS and Fibroids Small studies with mixed results
Managing Difficult IUC Cases LNG-IUS and Fibroids Small studies with mixed results Mercorio (2003): 75% persistent menorrhagia Starczewski (2000): 92% reduced bleeding Recommendations Off-label use; may violate precaution regarding cavity depth and distortion of uterine cavity Reasonable to attempt treatment with Mirena Documentation of informed consent content a must 132 132

Tips for IUC Insertion in Women with Fibroids
Determine fibroid location by ultrasound Fundal fibroids (intramural, sub-serous) that do not distort uterine cavity do not preclude IUC use Large sub-mucous fibroids, especially in lower uterine segment, contraindicate IUC use Evaluate for other pathology, e.g., polyp Ultrasound guidance may facilitate safe placement No data on efficacy, but probably not compromised with LNG-IUS or with Cu-T if fundal placement 133

Intrauterine Contraception; A Method That Will Prevail! IUC/EMB/PCB

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