Population Reports

1. Population Reports New Attention to the IUD Presentation prepared by Catherine Richey Based on Population Reports, Series B, Number 7, Feb. 2006, Prepared by Ruwaida M. Salem, MPH

2. This Presentation Will Cover … • Program requirements for high-quality IUD services • Evidence on infection risk and the IUD • Diagnosing STIs and assessing STI risk to minimize risk of infection • Summary of clinical characteristics of IUDs

3. The IUD: An Important Method with Potential

4. Key Characteristics: Provides very effective, safe, long-term, reversible protection from pregnancy; Requires little client action once the IUD is in place; Users tend to experience more cramping and bleeding, especially during the first three months. A small, flexible plastic frame. It is inserted into a woman’s uterus through her vagina and cervix. What Is the IUD?

5. Three Main IUDs Are Used Currently

6. IUDs Are An Important Choice • IUDs could help meet women's unmet need for family planning. • 100 million sexually active women in developing countries have an unmet need (want no more children or want to postpone for at least 2 years). • IUDs also could help reduce the number of unintended pregnancies due to contraceptive failure. • IUDs are very effective--more than many other methods.

7. Most IUD Users Are in China Distribution of IUD Users by Region, 2005 Data Sources: World Bank, DHS, RHS, United Nations, US Census Bureau’s International Database, and other nationally representative surveys Population Reports

8. Outdated Safety Concerns Have Held Back IUD Use • The Dalkon Shield was linked to septic miscarriage and pelvic inflammatory disease (PID), possibly due to its multifilament tails. • Available in the U.S. from 1971-1974 • Several biases in early research overstated risks of PID and infertility. • Example: Compared IUD users with users of contraceptive methods that protect against PID, such as oral contraceptive pills. • Most research since the 1980s: Serious complications are rare with modern IUDs.

9. Programmatic Challenges Also Have Held Back Use • IUD services require more infrastructure, equipment, and supplies than for other reversible methods. • Shortage of trained and motivated providers • Medical barriers • Outdated policies • Inappropriate provider practices

10. Program Requirements for Providing High-Quality IUD Services • Updated guidelines • Evidence-based provider practices • Infrastructure, equipment, and supplies • Core group of trained IUD providers • Positive client perceptions

11. Updating Guidelines To Remove Medical Barriers • WHO guidance can serve as the primary basis for developing and updating national service delivery guidelines. • 2004 Medical Eligibility Criteria for Contraceptive Use • 2004 Selected Practice Recommendations for Contraceptive Use • Involve local stakeholders • Helps promote consensus and ownership • Takes into account local situation

12. Improving Providers’ Practices Requires Training and Guidance • Programs should tailor approaches to the specific barriers to be overcome: • Seminars/workshops to address lack of knowledge • Educational outreach through opinion leaders to address provider biases • In Kenya, providers improved their knowledge, attitudes, and practices when they received training, a package of printed materials, and follow-up supervision. • Before training: 73% of providers thought that only women who had had children could use IUDs. • After training: 30% of providers still thought this.

13. Infrastructure Clean water Private space Bed/table Supplies Cotton balls Antiseptic solution Gloves IUDs IUD Services Require More Initial Service Delivery Costs than for Other Reversible Methods … • Equipment • Specula • Forceps • Uterine sound • Equipment for sterilization/ high-level disinfection

14. … But IUDs Can Be More Cost-Effective Over Time for Programs and Clients • An IUD can be used for many years, so users do not need to return for more supplies. • In the Mombasa, Kenya health care system, the average cost per year of protection in 2003: • IUD: US$4 • Tubal ligation: US$7 • Pills, implants, or injectables: between US$10 and $20

15. Programs Can Offer IUD Services in Low-Resource Settings • Bangladesh Rural Service Delivery Program adopted innovative strategies to ensure successful IUD provision through satellite clinics. • Transformed ordinary tables into gynecological beds; • Designed curtains to ensure privacy; • Adapted a portable steam sterilizer to sterilize and store IUD instruments and supplies during travel to satellite clinics.

16. Programs Can Keep Down IUD Service Costs By … • Offering immediate postpartum IUD insertion at birthing centers. • In Lima, Peru, and Nyeri, Kenya: IUD insertions at outpatient clinics cost 40% more than in hospital delivery rooms. • Sterile conditions are already present in the delivery rooms. • Expulsion rates are higher than with later insertion but not high enough to favor delaying insertion. • Can be a convenient time for insertion, especially for women who lack easy access to services.

17. Programs Can Keep Down IUD Service Costs By … • Permitting trained allied health workers to insert and remove IUDs. • Nurses, midwives, physicians’ assistants, and medical students can insert and remove IUDs safely and effectively when appropriately trained; • Cost to programs are lower than when physicians insert IUDs; • Some countries where health care professionals besides physicians routinely insert IUDs are: Chile, China, Ecuador, Ghana, Indonesia, Nigeria, Sweden, Thailand, Turkey, the U.S.

18. Programs Can Keep Down IUD Service Costs By … • Eliminating unnecessary routine follow-up visits. • WHO recommends one routine visit 3-6 weeks after insertion. • Most users with problems requiring medical intervention have symptoms which prompt them to return to the clinic even without a routine follow-up visit scheduled.

19. IUD Provision RequiresWell-Trained Staff • Training a core group of providers: • Helps ensure that providers see enough clients to maintain their IUD insertion and removal skills; • Can assure clients of high-quality IUD services by competent providers; • Allows referral of clients to the core group; • Has worked in Bangladesh, Bolivia, India, and Pakistan.

20. Strategies to Improve Clients’ Perceptions of the IUD • Low-cost educational materials and counseling • Honduran health workers gave short presentations to clients and asked them to distribute leaflets to friends and neighbors. • Branding • Clients recognize Pakistan’s Greenstar logo as a symbol of affordable, high-quality family planning services. • “Champions” to promote IUDs • In Sri Lanka teams of satisfied IUD users and midwives recruited more new IUD users than midwives working alone. • Community outreach • In Egypt mobile teams visited rural health units to provide IUD services to clients and educate women about the IUD.

21. Case Study: Kenya Takes Action To Increase Access to IUDs • Initiative began in 2001 to reintroduce the IUD into the National Family Planning Program. • Three-part approach: • Building consensus among stakeholders • Review guidelines and distribute advocacy kits • Improving service delivery • Explore new counseling and training techniques • Raising awareness and interest among clients • Radio broadcasts, community fairs, print materials

22. Kenya’s Program Efforts Help Renew Interest in the IUD • More women are choosing the IUD. • Between 2002 and 2005, the percentage of family planning clients choosing the IUD increased from 2% to 5% in the 68 participating clinics. • Kenya’s initiative is a model for other countries in sub-Saharan Africa. • Ethiopia, Ghana, and Uganda have shown interest in replicating Kenya’s initiative.

23. Very Low Overall Risk of Infection with IUDs

24. Overall Levels of Pelvic Inflammatory Disease (PID) in IUD Users Are Low • Long-term studies of IUD users, mostly in developing countries: • Acute PID rate: 0.6 to 1.6 per 1,000 woman-years (Farley, 1992) • Removals for PID: 4 to 11 per 1,000 women over 10- to 12-years of use (United Nations Development Programme, 1997 and World Health Organization, 2003) • Levels are similar to those among women in general.

25. 8 7 6 5 (per 1,000 Woman-Years) PID Rate 4 3 2 1 0 0 1 2 3 4 5 6 7 8 9 10 11 12 2 3 4 5 6 7 8+ Year Month (first year) Time Since IUD Insertion Risk of PID Greatest in the First Few Weeks After Insertion Source: Farley, 1992

26. PID Risk Probably Related to Having an STI at Insertion • PID rates vary according to prevalence of STIs in the population. • 0 PID cases among 4,300 IUD users in China • 8 PID cases among 846 IUD users in Africa (6 cases per 1,000 woman-years) (Farley, 1992) • Insertion process probably pushes organisms from lower to upper genital tract, where PID develops.

27. IUD Users Face a Low Risk of PID, Especially If at Low Risk of STIs • Except for the first few weeks after insertion, an STI may be no more likely to progress to PID in an IUD user than in another woman. • Mathematical modeling suggests that PID risk attributable to the IUD is low (Shelton, 2001). • In a setting with 10% STI prevalence, estimated attributable risk is 0.3% (3 cases in 1,000 women having IUDs inserted). • Among IUD users at low risk of STIs, estimated attributable risk is 0.15% (less than 2 cases in 1,000).

28. No Significantly Increased Risk of Infertility with IUDs • IUD use alone does not increase the risk of infertility; PID and exposure to STIs does increase the risk. • Studies show that 72% to 96% of women conceive within a year of IUD removal. • Levels are comparable to those among women who have never used contraception.

29. Women with HIV Generally Can Use IUDs Safely • IUDs do not increase a woman’s chances of acquiring HIV. • Complications of IUD use are not significantly more common among women infected with HIV than among those who are not. • IUDs do not increase the risk of HIV transmission from HIV-infected women to uninfected partners. • Providers should make it clear to clients that consistent and correct use of condoms is needed to avoid transmitting infections to their partners.

30. WHO Guidance Allows More Women to Use IUDs Adapted from World Health Organization, 2004

31. Minimizing the Risk of Infection

32. Approaches to Assessing a Woman’s Risk of STIs • Discuss behaviors or situations that may be likely to expose women to STIs. • Use a checklist developed by Family Health International (FHI) to assess whether the client has any conditions that would rule out IUD use. • Provider asks the client some questions related to her STI risk. • Ask the client to assess her own risk of STIs.

33. Common Risky Behaviors • Diagnosed with an STI in the last three months • Partner diagnosed with an STI in the last three months • Partner with STI symptoms • More than one sexual partner in the last three months without always using condoms • Unprotected sex with partner who has had more than one partner in the last three months • Situations suggestive of risky behavior • Example: Man works far from home for long periods of time

34. Using FHI’s Checklist To Assess STI Risk

35. Pelvic Exam Detects Some but Not Most Cervical Infections • WHO recommends looking for any of these 3 signs: • Mucopurulent discharge, • Cervix bleeds easily when touched with a swab, or • Positive swab test (WHO, 2005). • Treat a woman who has any of these 3 signs for gonorrhea and chlamydia and delay IUD insertion. • A pelvic exam can detect at best only 30% to 40% of cervical infections.

36. Client Self-Assessment May Indicate Current Infection • Mexico City study: Clients took part in 20-minute one-on-one information sessions with a nurse. • Discussed contraceptive methods, STIs, and risky behavior • Clients then selected the method they thought was most appropriate for them. • Physicians noted whether these clients should receive IUDs based on physical exam findings only. • Lower percentage of women inappropriately selected the IUD for themselves compared with physicians. • 48% of women with gonorrhea/chlamydia chose IUD; • 87% of providers approved IUD use for women with gonorrhea/chlamydia.

37. Providers Can Reduce Infection Risk By: • Assessing or asking the client to assess her individual risk of exposure to STIs, • Conducting a pelvic exam to look for signs of cervical infection, • Following routine infection-prevention procedures, • Not replacing IUDs unnecessarily, • Considering the use of prophylactic antibiotics, • Counseling all IUD users about signs and symptoms of STIs and PID, • Asking about symptoms of infection at the scheduled routine follow-up visit.

38. Clinical Characteristicsof the IUD

39. One of the Most Effective Methods of Contraception • Women who become pregnant during first year of use: • TCu-380A: 3 to 8 per 1,000 (0.3% to 0.8%) • LNG-IUD: 1 to 3 per 1,000 (0.1% to 0.3%) • Comparable to effectiveness of female sterilization • LNG-IUD is more effective than TCu-380A … • After 6 years of use, 20 women per 1,000 (2%) became pregnant while using the TCu-380A; • 5 women per 1,000 (0.5%) became pregnant while using the LNG-IUD. • … But LNG-IUD has lower continuation rates, largely because of removals due to lack of bleeding.

40. Copper-Bearing IUDs Can Increase Bleeding • Copper-bearing IUDs can increase blood flow volumes by 20% to 50%. • Most common complaint among IUD users • But many women still keep their IUDs. • Rates of removal because of bleeding or pain range from 1 to 17 per 100 women. • Increased bleeding could decrease blood iron levels.

41. Hormone-Releasing IUD Decreases Bleeding • LNG-IUD users initially experience more bleeding and spotting after insertion, but bleeding gradually decreases after three months. • 25% to 35% of LNG-IUD users have no bleeding at all by the end of the first year of use. • Counseling about bleeding changes is key to successful use. • LNG-IUD has several therapeutic applications because it reduces bleeding: • Increases blood iron levels • Treatment for menorrhagia • Progestin component of hormone replacement therapy

42. Expulsion Uncommon • Most expulsions occur in the first three months after insertion. • First-year expulsion rates vary from 2 to 8 per 100 women. • Reduce chance of expulsion by: • Correct insertion, with the IUD placed up to the top of the uterus, • Insertion within 10 minutes after delivery of the placenta during postpartum insertion.

43. Perforation Rare • Occurs when the IUD or a gynecological instrument pierces the uterine muscle wall • Careful insertion technique needed • Fewer than 2 perforations per 1,000 insertions have been reported in large clinical trials. • Most perforations are recognized at insertion, and the IUD can be removed at once without causing any serious problems.

44. Intrauterine Pregnancy Rare but Serious • 15-60% of uterine pregnancies end in miscarriage if the IUD is not removed. • Removing the IUD reduces risk of miscarriage to similar levels of risk faced by other women. • But removal process itself entails small risk of miscarriage. • Some studies found septic second-trimester miscarriage was more common among women who left their IUDs in place than among women not using IUDs at conception.

45. IUDs Reduce Risk of Ectopic Pregnancy • Pregnancy is rare among IUD users, so ectopic pregnancy is even rarer. • IUDs reduce ectopic pregnancy rates to 10% to 50% of the level among women not using contraception. • But in rare events when an IUD user does become pregnant, the pregnancy is more likely to be ectopic than in a woman not using an IUD. • In users of copper-bearing IUDs, an estimated 1 in every 13 to 16 pregnancies is ectopic (6% to 8%).

46. Photo and Illustration Credits Slide 1: Catherine Richey/CCP Slide 3: © David Alexander/CCP, Courtesy of Photoshare Slide 4: © David Alexander/CCP, Courtesy of Photoshare Slide 5: © David Alexander/CCP, Courtesy of Photoshare Slide 11: © Marcel Reyners, Courtesy of Photoshare Slide 15: Photo: Karen Beattie/EngenderHealth Illustrations: Adapted from JHPIEGO, IUD guidelines for family planning service programs: A problem solving reference manual Slide 30: JHPIEGO, IUD guidelines for family planning service programs: A problem solving reference manual Slide 41: JHPIEGO, IUD guidelines for family planning service programs: A problem solving reference manual

47. References • Centers for Disease Control. Current trends ectopic pregnancy: United States, 1990-1992. Morbidity Mortality Weekly Report 44(3): 46-48. Jan. 27, 1995. (Available: <http://www.cdc.gov/mmwr/preview/mmwrhtml/00035709.htm>) • Farley, T.M., Rosenberg, M.J., Rowe, P.J., Chen, J.H., and MEIRIK, O. Intrauterine devices and pelvic inflammatory disease: An international perspective. Lancet 339(8796): 785-788. Mar. 28, 1992. • Faundes, A., Telles, E., Cristofoletti, M.L., Faundes, D., Castro, S., and Hardy, E. The risk of inadvertent intrauterine device insertion in women carriers of endocervical Chlamydia trachomatis. Contraception 58(2): 105-109. Aug. 1998. • Lazcano Ponce, E.C., Sloan, N. L. Winikoff, B., Langer, A., and Coggins, C. The power of information and contraceptive choice in a family planning setting in Mexico. Sexually Transmitted Infections 76(4): 277-281. 2000.

48. References (continued) … • Luukkainen, T., Allonen, H., Haukkamaa, M., Holma, P., Pyörälä, T., Terho, J., Toivonen, J., Batar, I., Lampe, L., Andersson, K., Atterfeldt, P., Johansson, E.D.B., Nilsson, S., Nygren, K.G., Odlind, V., Olsson, S.E., Rybo, G., Sikström, B., Nielsen, N.C., Buch, A., Osler, M., Steier, A.J., and Ulstein, M. Effective contraception with the levonorgestrel-releasing intrauterine device: 12-month report of a European multicenter study. Contraception 36(2): 169-179. Aug. 1987. • Morrison, C.S., Sekadde-Kigondu, C., Miller, W.C., Weiner, D.H., and Sinei, S.K. Use of sexually transmitted disease risk assessment algorithms for selection of intrauterine device candidates. Contraception. 59(2): 97-106. Feb. 1999. • Pap-Akeson, M., Solheim, F., Thorbert, G., and Akerlund, M. Genital tract infections associated with the intrauterine contraceptive device can be reduced by inserting the threads into the uterine cavity. British Journal of Obstetrics and Gynaecology 99(8): 676-679. Aug. 1992.

49. References (continued) … • Shelton, J.D. Risk of clinical pelvic inflammatory disease attributable to an intrauterine device. Lancet 357(9254): 443. Feb. 10, 2001. • Sinei, S.K., Schulz, K.F., Lamptey, P.R., Grimes, D.A., Mati, J.K., Rosenthal, S.M., Rosenberg, M.J., Riara, G., Njage, P.N., Bhullar, V.B., and Ogembo, H.V. Preventing IUCD-related pelvic infection: The efficacy of prophylactic doxycycline at insertion. British Journal of Obstetrics and Gynaecology 97(5): 412-419. May 1990. • Sivin, I., Alvarez, F., Diaz, J., Diaz, S., El Mahgoub, S., Coutinho, E., Brache, V., Diaz, M.M., Faundes, A., Pavez, M., Mattos, C.E.R., and Stern, J. Intrauterine contraception with copper and with levonorgestrel: A randomized study of the TCu 80A and levonorgestrel 20 mcg/day devices. Contraception 30(5): 443-456. Nov. 1984. • Skjeldestad, F.E., Halvorsen, L.E., Kahn, H., Nordbo, S.A., and Saake, K. IUD users in Norway are at low risk for genital C. trachomatis infection. Contraception 54(4): 209-212. Oct. 1996.

50. References (continued) … • United Nations Development Programme, United Nations Population Fund, World Health Organization, and World Bank. Special Programme of Research Development and Research Training in Human Reproduction. Long-term reversible contraception: Twelve years of experience with the TCu380A and TCu220C. Contraception 56(6): 341-352. 1997. • United Nations (UN). World contraceptive use 2003. [Wall Chart]. New York, UN, 2004. (Available: <http://www.un.org/esa/population/publications/contraceptive2003/WCU2003.htm>) • Walsh, T.L., Bernstein, G.S., Grimes, D.A., Frezieres, R., Bernstein, L., and Coulson, A.H. Effect of prophylactic antibiotics on morbidity associated with IUD insertion: Results of a pilot randomized controlled trial. IUD Study Group. Contraception 50(4): 319-327. Oct. 1994.