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The Latest Scientific Knowledge and WHO Guidance about IUDs. Roy Jacobstein, M.D., M.P.H. Clinical Director, ACQUIRE EngenderHealth IUD Standardization Workshop Accra, Ghana June 2006. IUDs: Effectiveness and Safety. Highly effective, comparable to FS, V, Implants
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The Latest Scientific Knowledge and WHO Guidance about IUDs Roy Jacobstein, M.D., M.P.H. Clinical Director, ACQUIRE EngenderHealth IUD Standardization Workshop Accra, Ghana June 2006
IUDs: Effectiveness and Safety • Highly effective, comparable to FS, V, Implants (“Reversible sterilization”) • 12-13 yrs with CU-T (FDA labels for 10) • 3-8/1000 become pregnant in 1st yr of use • WHO study: • Average annual failure rate 0.4% • Cumulative failure rate after 12 yrs 2.2% • Very safe for almost all women(e.g., PP, PA, interval; BF; HIV-infected; young; nulliparous …)
Research (or K-to-P) Paradigm: Evaluate Concerns via Medical Evidence New UnderstandingsNew Perceptions New “Truths” MedicalEvidence Some “Concern”
Key Provider Concerns Related to Whether or not to Provide IUDs Three main provider concerns: • Pelvic Inflammatory Disease (PID) • Infertility • HIV/AIDS Evidence is reassuring …
Other Related Concerns • How to assess “High Individual Risk” for STIs in low-resource settings • Ruling out pregnancy before giving IUD • Prophylactic antibiotics at insertion — yes or no? • Relation of IUD to ectopic pregnancy • Relation of IUD to anemia
Concern: Does IUD Cause PID? • We know PID is an infectious disease, caused by sexually-transmitted organisms (Chlamydia,gonococcus) • But is the IUD an “accomplice”? • Two questions raised; “Is there … • Q1: ↑Risk from IUD insertion process?” • Q2: ↑Risk from post-insertion bacterial exposure? (i.e., “Does IUD facilitate later PID?”)
Medical Evidence: Low PID Rates among IUD Users * • WHO study: 23,000 insertions, 51,000 wmn-yrs F/U • Overall rate of PID: 1.6 cases of PID/1000 women-years (i.e., 998.4 /1000 do NOT get PID) • First 20 or so days: risk ↑ (though still very low: 7/1000 women-years) [This answers Q. 1] • Later periods: comparable risk as in women without IUD; [This answers Q. 2; evidence-base for WHO SPR rec. only 1 routine F/U visit needed * Farley et al., Lancet 1992
Risk of PID: Very Low & Far Lower Than Many Imagine or Believe PID Incidence Rate by Time Since Insertion PID Rate (per 1000 woman years) 8 8 6 6 4 4 2 2 0 0 1 2 3 4 5 6 7 8 9 10 11 12 2 3 4 5 6 7 8+ Months (first year) Years Time Since Insertion Source: Farley et al, 1992, in FHI 2004
But What About Risk of PID in High-Prevalent STI Settings? • Perhaps WHO data included only low risk women? (Study done in Thailand and Latin America) • What about in low resource settings, where STI testing is not feasible? • But no prospective studies exist, thus we need to (can only) estimate risks
Modeling the Attributable Risk * High Risk Setting of 10% Cervical Infection Simple Screening Questions No Screening Only 1 in 667 would get PID from IUD (1.5 cases/1000) 0.15% Only 1 in 333 would get PID from IUD (3 cases/1000) 0.30% * Shelton, Lancet 2001
PID Risk from IUD, in Perspective • PID Risk from IUD: • 1.6 cases per 1000 women/year • 1 in 667 insertions or 1 in 333 insertions in high-STI settings • Other RH Risks in sub-Saharan Africa: • Lifetime risk of maternal death: 1 in 16 * • Induced abortion: 35/1000 women / year** • Abortion death: nearly 7 per 1000 procedures** *AbouZahr, Br Med Bull 2003 **Guttmacher Institute, 1999
Emerging View on PID • Insertion process, due to presence of sexually- transmitted bacteria, ↑ short-term PID risk in some women (those at risk of STIs). This risk is small • IUD does not appear to facilitate development of PID in post-insertion period • Overall, risk of PID is very small • Even in high-STI settings, risks appear small (and much smaller than typically believed) • Risk must be considered in context of other risks • These facts often not widely known -- our challenge
Concern: Does IUD Cause Infertility? • Concern understandable: We know PID infertility • Single PID event 13% chance of tubal occlusion* (Or, 87% will not get infertility from single episode of PID) • More PID events higher chance of infertility * Westrom, Am J Obstet Gynecol 1975
Medical Evidence:“IUD Not Associated with Tubal Infertility”* • Mexico: case-control study of nulligravid infertile and primigravid women • Similar patterns of previous Cu-IUD use • Blood tests for chlamydial antibodies: infertile women: twice the % of antibodies • Thus, the real infertility “culprit” not IUD but Chlamydia trachomatis (and gonococcus) * Hubacher et al., N Engl J Med 2001
Infertility Risk from IUD, in Perspective: “Harm of Doing” vs “Harm of Not Doing” • In hypothetical high-risk setting, if 25% of PID causes infertility, without screening by history for every ~2,700 IUD insertions there would be 1 case of infertility. • In same high STI-prevalence settings, the consequences of denying IUDs to 2,700 women: • 2,160 pregnancies • At least 400 serious obstetrical complications • 1-2 deaths from pregnancy and childbirth • Unknown mortality & morbidity from unsafe abortion * Shelton, Lancet 2001
Concern: Is IUD Use by HIV-Infected Women Safe?” Three possible questions to consider: • Does the IUD increase risk of HIV acquisition? • Is IUD use safe for HIV-infected women, i.e., does the IUD increase her other health risks? • Does an HIV+ IUD user ↑risk to her sero-negative male partner?
Medical Evidence, Question 1: No ↑Risk of HIV Acquisition from IUD Kapiga Musicco European Carael Plourde Morrison Sinei 1996 Martin 1996 1998 1995 1989 Mati 1995 1988 1992 1997 10 Harmful Relative Risk (Log Scale) & 95% CI 1 Protective 0.1
Medical Evidence, Question 2: IUD Use Is Safe for HIV-infected Women • Cohort studies in Kenya • Compared HIV-infected and HIV-non-infected women using IUDs • Findings: Same low rates of overall (7-10%) and infectious (0.2-2%) complications • Conclusion: HIV does not appear to increase risk of IUD-related adverse events (inc. PID) Sinei et al, Lancet, 1998Morrison et al., Br J Obstet Gynaecol 2001
Medical Evidence, Q3: IUD Use by HIV+ Woman is Safe for Sero-neg Partner * • Ancillary study to Kenyan cohort * • Asked if presence of IUD increases cervical shedding of HIV? (Increased shedding a proxy for increased risk of being infective.) • Found cervical shedding of HIV was not increased with IUD use • Inferential conclusion: IUD use by HIV+ women appears safe for HIV-neg partner * Richardson et al., AIDS 1999
WHO’s Medical Eligibility Criteria for Contraceptive Use (MEC, 2004) • Based on systematic reviews of latest clinical & epid research • Covers 19 methods, 120 medical or special conditions • ~ 1700 recommendations on who can use which methods • Gives guidance to programs & providers • Informs natl. guidelines, policies & standards • Helps reduce medical policy & practice barriers, leading to improved quality & use of FP methods and services
What Question Is Answered by WHO’s MEC? In the presence of a given condition or classification, e.g., STIs or HIV/AIDScan a particular FP method be used? (And with what degree of caution or restriction, as reflected in 4 categories or gradations based on risks & benefits)?
How to Determine High Individual Risk of STIs • It’s difficult • Providers need to assess risk for each individual woman; not to base their decision to give IUD on local STI levels. (Remember: even with levels of STI as high as 10%, risk of clinical PID is low) • FHI’s STI (& R/O pregnancy) tools helpful
Key Screening Questions to Determine High Individual Risk of STIs • Within the last 3 months have you had more than one sexual partner (outside of a polygamous union)? • Within the last 3 months, have you been told you have an STI? • Within the last 3 months, has your partner been told he has an STI? • Does your partner have any symptoms of STI (e.g., penile discharge or sore, urinary pain or burning)? • Do you think your partner has had another sexual partner within the last 3 months? (Outside of a regular polygamous union, if one exists.)
Asking the Screening Questions: Some Considerations • Need sensitive counseling in a private setting • Simply asking questions directly may not yield accurate assessment: sex = a sensitive topic • Important to be neutral & non-judgmental • Explain what places a woman at high individual risk • If risk-associated behaviors / situations presented, woman often best judge of her own risk and will usually choose another method if risks explained • Decide together, or ask her to assess her own risk
Other Provider Concerns about IUDs • Prophylactic antibiotics at insertion? • Ruling out pregnancy (FHI checklist) • Side effects management • Ectopic pregnancy • Anemia
Prophylactic Antibiotics? “Data do not confirmthe utility of prophylactic administration of antibiotics …”* * Cu-T 380A labeling
Prophylactic Antibiotics?* • Cochrane Review: Meta-analysis of RCTs (randomized, controlled trials: ”gold standard”) • 4 RCTs 1990-1998, compared oral doxycycline (or azithromycin) vs. placebo or no rx; found: • No significant ↓ in risk of PID(but ↓ 1/3 in Kenya) • No ↓ in premature discontinuation of use • Small ↓ (18%) in unscheduled return visits (33% in Kenya) * Grimes et al., Contraception 1999
Prophylactic Antibiotics: WHO Recommendations* Question 10. Should prophylactic antibiotics be provided for Copper-bearing IUD insertion? • Prophylactic antibiotics generally not recommended for Cu-bearing IUD insertion. • In settings of high prevalence of cervical gonococcal and chlamydial infections and limited STI screening, such prophylaxis may be considered. • Counsel the client to watch for symptoms of PID, especially during the first month. * WHO, Selected Practice Recommendations (SPR), 2004
Ruling Out Pregnancy* Study in Kenya found: • 35% of clients FP were denied services because they were non-menstruating, yet • A checklist with six simple questions was able to rule out pregnancy in 88% of women (who could then get a FP method) • had > 99% negative predictive value (compared to pregnancy test) Checklist for ruling out pregnancy among FP clients in primary care” * Stanback et al., Lancet 1999
Ectopic Pregnancy: Rates by Method Typical ectopic pregnancy rate per 1000 woman years of method use 6.5 2.3 1.5 1.2 0.6 0.4 0.2 0.02 Female Sterilization IUD (TCU 380A) Male Sterilization No method Diaphragm Condom IUDs OCs Adapted from: Sivin 1991, in FHI 2004
Ectopic Pregnancy: Risk With IUD Use Markedly Reduced • IUD highly protective against ectopic pregnancy — over a thirty-fold reduction with Cu-T (Absolute risk low, since IUD so effective a contraceptive) • Pregnancy with IUD in place 5-6x more likely to be ectopic than in a non-user (relative risk higher) • The large majority (88-90%) of given pregnancies with IUD in place will not be ectopic • Still must consider ectopics in women using IUDs who have acute abdomen or sxs of pregnancy)
Anemia • The older, inert IUDs were sometimes associated with significantly increased vaginal bleeding • With copper IUDs, vaginal blood loss largely unaffected and significant reduction effect on hemoglobin levels is uncommon • Thus, WHO classifies anemia as Category 2 for copper IUDs
Progesterone-Releasing Intrauterine Systems (IUS) • Mirena® — continuous release of a small amount (20 micrograms) of the progestin, levonorgestrel (same hormone in Norplant and Jadelle) • Effective 5 years / Failure rate in 1 year: ~ 0.1-0.2% • Same benefits and side effects of progestins • Reduces menstrual cramps and flow • Reduced flow may reduce iron deficiency anemia • But too expensive for programs (30-80 times more costly: ~$40, vs. $0.50 - $1.50 for Cu-T 380A)
ICA Foundation: Free & Subsidized LNG-IUS • Partnership: Bayer Schering & Population Council • EngenderHealth on the Board of Directors • Gives combination of donations (free) & sales at public sector price of US$40 per IUS • Projects in Africa: Ghana, Kenya, Nigeria, South Africa • Who can apply for a donation?: public health organizations (public & private sector), NGOs • For more information: • ICA Foundation, PO Box 581, FI-20101 Turku, Finland • Website: http://www.ica-foundation.org