LARC: Long Acting Reversible Contraception Disclosures I have no relevant financial disclosures Jennifer Kerns, MD, MPH Assistant Professor, UCSF Obstetrics, Gynecology and Reproductive Sciences San Francisco General Hospital October 23, 2013 Objectives To review the evidence for the role of LARC in preventing unintended pregnancies To be able to use the medical eligibility criteria to assess suitability of LARC methods for individual patients To review appropriate counseling regarding LARC methods Do you use the CDC or WHO Medical Eligibility Criteria for Contraceptive Use (MEC)? a) Yes b) No 77% 23% To address controversies regarding LARC Yes No 1
A 32 year old woman desires intrauterine contraception. She is in a monogamous relationship. When would you test her for GC/CT? a) A few weeks before IUC insertion b) Day of IUC insertion c) Would not screen 13% 19% 67% Which is the most effective form of emergency contraception? a) Levonorgestrel 150mg b) Copper IUD c) High dose combined OCPs d) Ulipristal acetate 23% 53% 13% 11% A few weeks be... Day of IUC ins... Would not scre... Levonorgestrel... Copper IUD High dose comb... Ulipristal ace... The problem: many pregnancies are unintended Unintended Intended Unintended Births Intended Abortions Contraception pregnancy prevention For non-larc methods, effectiveness is not the same as efficacy Need to take action for method effectiveness Monthly re-supply Interruption of contraceptive use Need to access health care 25% were using a method Jones PSRH 2008 Mosher Vital Health Stat 2010 2
Advantages of LARC Inconsistent use of pills is the norm What is LARC? Long-acting No need to act to continue the method Reversible Return to fertility is immediate Methods Implant IUD Potter L et al. Fam Plann Perspect. 1996 9 Advantages of LARC Why talk about LARC? LARC methods are the most effective at preventing pregnancy LARC methods are most effective Depo Pill, LARC Condom patch, ring High continuation rates high user satisfaction No interruption of contraceptive use Reduced need to access health care Cost-effective Trussell Contraception 2011 Trussell. Contraception 2011. Number of women pregnant in 1 year out of 1,000 12 3
Advantages of LARC LARC continuation rates are highest of all reversible methods LARC methods are cost-effective Misinformation about LARC 1-year continuation rates Trussell J in Hatcher R et al. Contraceptive Technology. 2007 Mestad et al. Postgraduate Medicine 2009 13 Chiou CF et al. Contraception. 2003. Trussell J. Contraception. 2012. 14 Advantages of LARC Few US women know about LARC Less than half of young women have heard of IUDs Two-thirds do not know safety or effectiveness Can my patient use this method? Health care providers are primary source of information on LARC Many providers have not integrated LARC into counseling CDC Medical Eligibility Criteria Evidence-based guidelines for safety of methods with coexisting conditions Similar to WHO but US-specific Fleming KL et al, Contraception 2010. Barrett M el al, J Pediatr Adolesc Gynecol 2012. Harper C et al. Family Medicine. 2012. www.cdc.gov/mmwr/preview/mmwrhtml/rr59e0528a1.htm 15 4
CDC Medical Eligibility Criteria (MEC) MEC Categories 1 Can use the method No restrictions 2 Can use the method Advantages generally outweigh theoretical/proven risks 3 Should not use method unless no other method is appropriate Theoretical/proven risks generally outweigh advantages 4 Should not use method Unacceptable health risk What is LARC? Medical Condition Birth Control Methods Single rod etonogestrel implant: Nexplanon Radio-opaque rod Works for 3 years Nearly 100% effective Failure 0.05% (vs 0.5% permanent sterilization) Inhibits ovulation, cervical mucus Etonogestrel = active metabolite of desogestrel, a 3 rd generation progestin MEC Category FDA label. Issued 7/17/2006. Levine et al. Contraception. 2008. 20 5
Levonorgestrel intrauterine system (LNG-IUS): Mirena and Skyla Copper T 380a intrauterine device: (ParaGard ) Effective for 5 years Nearly 100% effective Failure 0.2-0.8% Cervical mucus Non-contraceptive benefits Effective for 3 years 14 mcg LNG per day Frame 1.1 x 1.2 in (vs 1.3 squared) Insertion tube 0.15 in wide (vs. 0.19 in) Non-hormonal Efficacy like other IUDs Effective for up to 12 years Most effective method of emergency contraception Cleland K et al. Human Reproduction. 2012. Glasier A et al. Contraception. 2011. How do I counsel a woman about using a LARC method? Patient choice Not our job to coerce women to use LARC Values clarification Provide information about methods *effectiveness *benefits *risks / side effects Elicit patient s values and preferences Shared decision making Satisfaction with METHOD CHOICE 6
Side effects & benefits of LARC Starting the discussion Reproductive goals / reproductive planning Past contraceptive experience what has/ hasn t worked? Discuss methods in order of effectiveness Discuss potential changes in bleeding patterns Bleeding changes with LARC Copper T: bleeding may be heavier and longer Mirena: spotting during first 6 months, then lighter, 30% with amenorrhea Skyla: spotting during first 6 months, then lighter, ~10% with amenorrhea Implant: unpredictable bleeding and spotting, overall lighter, 20% stop having period Blumenthal et al. Human Reprod Update 2011 Suvisaari J et al. Contraception 1996 Gemzell-Daniellson et al. Fertil Steril 2012 Mansour D et al. Eur J Contracept Reprod Health Care 2008 Hidalgo M et al. Contraception 2002 26 Counseling for LARC Contraceptive effectiveness, WHO Contraceptive effectiveness, Bedsider WHO et al. Family Planning: A Global Handbook for Providers. 2007. 27 7
Controversies with LARC methods Case #1 23 yo G0 is interested in using an IUD. History of chlamydia in college. She has had 3 male partners in the past year. Case #1 How do her risk factors for PID influence your counseling on IUC appropriateness? Should you test her for GC/CT? Misinformation about LARC Can women who have no children use an IUD? Yes! IUDs are appropriate for women with no children Some considerations Skyla Pre-insertion pain medication Paracervical block Veldhuis H. Eur J Gen Pract. 2004. Suhonen S et al. Contraception. 2004. Thonneau P et al. Human Reprod. 2006. ACOG Committee Opinion 539. Obstet Gynecol. 2012. 8
Misinformation about LARC Can women with a history of STIs use an IUD? Yes! Past infections are not a contraindication to any method of contraception. Sexually Transmitted Infections CDC Medical Eligibility for Initiating Contraception Condition LNG-IUS or Copper IUD Current vaginitis 2 Current chlamydia, gonorrhea, or purulent cervicitis 4 Can women with a history of PID use an IUD? Yes! Women with PID history can use IUDs. Active PID is a contraindication Pelvic inflammatory disease CDC Medical Eligibility for Initiating Contraception Condition Past PID, subsequent pregnancy Past PID, no subsequent pregnancy LNG-IUS or Copper IUD Current PID 4 1 2 Misinformation about LARC ACOG Practice Bulletin. Obstet Gynecol. 2005. Skjeldestad, et al. Contraception. 1996. Centers for Disease Control. MMWR. 2010. 33 ACOG Practice Bulletin. Obstet Gynecol. 2005. Skjeldestad F et al. Contraception. 1996. Centers for Disease Control. MMWR. 2010. 34 What we know about IUDs and PID Unprotected sex w/ infected partners PID Transient increased risk at insertion 22,908 insertions: 9.7/1000 w/in 20 days 1.4/1000 after 20 days Routine GC/CT screening not necessary Retrospective cohort, n=57,728 IUD insertions Evidence-based STI screening, tx if + test Among all women: Risk of PID Non-screening = Screening OR= 1.05 (0.78, 1.43) Among screened women: Risk of PID Same day = Pre-insertion OR=.99 (0.64, 1.54) Beyond time of insertion Overall decreased risk with LNG IUS No increased risk with Copper IUD Women appropriately selected for non-screening Most accurate screening time is day of insertion Farley Lancet 1992 Walsh Lancet 1998 Sufrin et al Obstet Gynecol 2013 9
Who should be screened? Follow CDC and USPSTF guidelines for GC/CT screening at IUD insertion Annually if < 26 yo and sexually active If risk factors (new partner, symptoms, other STI) Screen on same day as insertion No cases of PID when PP switched to same day screening No benefit to prophylactic antibiotics Case #2 An 18yo G0 presents having had unprotected sex the night before, requesting emergency contraception. Her BMI is 34. She had been using pills, but had a hard time remembering to take them. What do you offer her? USPSTF Am J Prev Med 2001 CDC MMWR #59 2010 Goodman Contraception 2008 Grimes Contraception 1999 Misinformation about LARC EC pills (LNG) less effective for obese women Emergency contraception Percent of women pregnant after taking EC pills Glasier A et al. Contraception. 2011. 39 10
Misinformation about LARC Case #3 28 yo G4P1 presents for a 16-week abortion, and is considering using a LARC method. Is it safe for her to have the implant placed immediately after the abortion? Can a woman use LARC immediately after an abortion? Yes, post-abortion LARC is safe and effective Post-abortion IUD continuation and expulsion rates similar to interval insertion Postabortion CDC Medical Eligibility for Initiating Contraception Condition Copper IUD LNG- IUS Implant First trimester 1 1 1 Second trimester 2 2 1 Pakarinen et al. Contraception. 2003. Li et al. Contraception. 2004. Goodman et al. Contraception. 2008. Centers for Disease Control. MMWR. 2010. 42 Case #3 The same woman returns to you 7 months later. She has had spotting every day for the last 6 weeks. How do you counsel women on bleeding expectations with ETG implant? How do these side effects compare to other methods? How can you manage these symptoms? Unscheduled bleeding & hormonal contraception Common reason for discontinuation Mechanism poorly understood progestin-induced endometrial atrophy? vascular fragility, MMPs Increased with: smoking, inconsistent use Lopez Cochrane Database 2008 Mansour Contraception 2010 11
Women who discontinue due to bleeding irregularities CHC DMPA LNG-IUD Cu-IUD Implant 3% 1 7-12% 2,3 2.5% 5% 10% ETG Implant & Bleeding 17 bleeding-spotting days/90d Infrequent 34% Amenorrhea 22% Datey 1995 Contraception Cropsey 2010 J Womens Health Colli 1999 Contraception Suhonen 2004 Contraception Rivera 1999 Contraception Blumenthal 2008 Eur J Contracept Reprod Health Care 1/3 of women who discontinue implant do so for bleeding Darney Fertil Steril 2009 Mansour Contraception 2010 Mansour Eur J Contr Repro Health Care 2008 Prolonged bleeding 18% Frequent bleeding 6% Implant bleeding: management Scant data some based on LNG implant NSAIDs- variable dose and type RCT 204 with prolonged/frequent bleeding Intervention x 5 days, Q28 days x 90 days Days to stop bleeding Mife + EE Mife +Doxy Doxy Doxy + EE Placebo 4.0 (3.5-4.6) No difference in overall # bleeding/spotting days Phaliwong et al 2004 J Med Assoc Thai Weisberg et al 2009 Hum Reprod 4.4 (3.8-5.2) 6.4 (4.4-9.2) 6.4 (4.8-8.6) 6.4 (5.1-8.0) One approach... Therapy Evidence? 1. COC x 21d/7d (3 mo) Minimal (II-3) 2. Cyclic progestin (MPA 10bid) x 21d/7d (3mo) Anecdotal (III) 3. POP daily up to 3 mo Anecdotal (III) 4. NSAIDs, COX-2 inhibitors x 5-10d Tranexamic acid 500 bid x 5d Adapted from Mansour et al 2010, and 2011 Contraception Minimal (II-3) Anecdotal (III) 12
Closing thoughts LARC methods have the potential to decrease unintended pregnancy and increase the match between patients reproductive goals and contraceptive use The CDC MEC is an evidence-based guide for determining safety for an individual LARC methods are safe among women who Are nulliparous Have a history of STIs and/or PID Are post-abortion (and postpartum) 13