Slide 1

Using the Best Evidence to Select the Best Contraceptive Jody Steinauer, MD, MASDept. Ob/Gyn & Reproductive SciencesUniversity of California, San Francisco

12010 US Medical Eligibility Criteria Post-abortionOC/P/RPOPDMPAImplant1st trimester11112nd trimester1111Immediate post-septic abortion1111

How do you do it?Post-placental IUD Insertion

2173How comfortable would you be offering a woman an IUD if she had a history of Chlamydia and no current infection?Very comfortableSomewhat comfortableUncomfortable

Would you offer a 20 year-old woman with migraine the combined oral contraceptive?YesIt dependsNo

ObjectivesRemember contraception in your clinical practice.

Find evidence about contraception for women with possible contraindications.

Encourage women to use longer acting methods.

Address recent controversies and myths.

Review extremely recent & important information.

6Outline:Unintended pregnancyContraceptive evidenceContraceptive methods updatesExtended cycle combined hormonal methods IUDContraceptive implant

Jane is a 27 year-old woman taking combined oral contraceptive pills, who presents to your clinic for an annual examination. She reports having missed two periods. Her urine pregnancy test is positive.

76.4 Million US Pregnancies Annually

52 % Intended48 % UnintendedJones PSRH 2008 822% of all pregnancies end in abortion54% of women who get abortions were using some kind of contraception (most commonly the pill or condom) during the month before they got pregnant. In 2005, there were 1.21 million abortions performed, down from 1.31 in 200019.4 abortions per 1000 w-yrsAbout half of US women will have an unintended pregnancy by the time they are 45. One third will have an abortion6.4 Million U.S. Pregnancies Annually

52 % Intended25 % UnintendedDespite method use23 % UnintendedNo method usedHenshaw Family Planning Perspectives, 19989Why did Jane get pregnant?Jane ran out of pills last month. She tried to schedule an appointment, but because she was overdue for a pap smear the clinic staff couldnt call in refills. Today was the first day she could get an appointment.

10Provider Barriers to ContraceptionClinical VisitBP check to initiate estrogen-containing methodsNo pap smear or other examinationRefill methods without seeing patientRemember birth control48% using D or X rx counseled on contraception1

Knowledge about contraindicationsUS guidelines

Schwarz Ann Intern Med, 2007.11Case: Counseling IssuesAfter Jane has completed her pregnancy she returns to you for contraceptive counseling. Jane has had migraine headaches since she was a teen. She has no aura and they have not changed with the combined pill.

Can she use the pill again?Can my patient use this method?1Can use the methodNo restrictions2Can use the methodAdvantages generally outweigh theoretical or proven risks.3Should not use method unless no other method is appropriateTheoretical or proven risks generally outweigh advantages4Should not use methodUnacceptable health riskWHO Medical Eligibility Criteria (MEC)www.reproductiveaccess.orgwww.who.int

Medical conditionsBirth controlmethodsMEC CategoryUS MEC: 2010Current WHO MEC contains > 1800 recommendationsNo need to adapt most recommendationsScience is the sameRecommendations are used around the worldCDC accepted majority of WHO recommendationsAdapted a few for the US context15Our first step was to determine the scope of the adaptation. The current WHO MEC includes over 1800 individual recommendations. It was not possible, nor was it necessary, to adapt each of those recommendations for use in the United States. The science-base and, because of CDCs close partnership with WHO, the process for identifying and synthesizing the evidence would be the same. In addition, these recommendations are widely used around the world, including in the US because of this, WHO has a strong commitment to only changing guidance when there is a compelling reason based on new evidence. Therefore, CDC made the decision to accept the majority of the WHO recommendations for the US. However, we thought there might be a small number of existing WHO recommendations that could be adapted for best implementation in the US context. U.S. Medical Eligibility Criteria for Contraceptive Use (USMEC)United States Medical Eligibility Criteria for Contraceptive Use http://www.cdc.gov/reproductivehealth/unintendedpregnancy/USMEC.htm

16US MEC: 2010Existing WHO guidanceBreastfeeding and CHC Breastfeeding and progestinonly methodsPostpartum IUDsOvarian cancer and IUDsFibroids and IUDsDVT/PE and hormonal contraceptionValvular heart disease and IUDs

New medical conditionsRheumatoid arthritisEndometrial hyperplasiaInflammatory bowel diseaseBariatric surgerySolid organ transplantationPeripartum cardiomyopathyMigraine and Combined Hormonal Contraception (CHC)Migraine, COC*, and Stroke Synergistic effect of Migraine and COCOR 8.7 (95% CI 5.0-15.0) 1OR 13.9 (95% CI 5.5-35.1) 2

Etminan BMJ, 2005. Tzourio BMJ, 1995. *COC= combined oral contraceptive pills19WHO says: Non-migrainous (mild or severe)1 2Migraine(i) without focal neurologic symptomsAge < 352 3 Age > 353 4(ii) with focal neurologic symptoms4 4 (at any age)

Prodrome = photo/phonophobia, N/V These are not focalFocal symptoms = vision changes, numbness, parasthesias

Migraines increase risk of strokeOCPs increase risk of stroke

Background risk for MI in women is low; AGE 20-24 RATE 0.0014 Per 10,000 woman yearsAGE 30-34 0.0017 at AGE 40-44 rate 0.213 per 10,000 women-years

Ischemic stroke 0.06 at age 20-24 0.098 at age 30-34 0.160 at age 40-44 per 10,000 woman-yearsHemorragic stroke 0.127 at age 20-24 0.243 at age 30-34 0.463 at age 40-44

BASELINE RISK OF STROKE LESS than ONE per 10,000 woman-years

OCPs may increase that risk by 2 -- so 2 cases per 10, 000 woman-years.Recent meta-analysis by Baillargeon et al. J Clin Endocrinol Metabloism

WHO/US: Headaches and CHC* Non-migrainous 1

Migraine(i) w/o focal neurologic symptomsAge < 352 Age > 353 (ii) w/ focal neurologic symptoms4 (at any age)

Focal symptoms = AURA = vision changes, numbness, parasthesiasNon-focal = Prodrome, photo/phonophobia, N/V

20WHO/US: Headaches and CHC* InitiateContinueNon-migrainous1 2

Migraine(i) w/o focal neurologic symptomsAge < 352 3 Age > 353 4(ii) w/ focal neurologic symptoms4 4 (at any age)

Focal symptoms = AURA = vision changes, numbness, parasthesiasNon-focal = Prodrome, photo/phonophobia, N/V 21Absolute Risk of Stroke No COCCOCHealthy6 per 100,000 /yr12 per 100,000 /yrMigraine12 per 100,000 /yr19 per 100,000 /yrMigraine + aura18 per 100,000 /yr30 per 100,000 /yrStroke in pregnancy: 34 per 100,000 / year Speroff & Darney Clinical Guide for Contraception 2005Case: Counseling IssuesAfter reviewing the US and WHO MEC you decide Jane could use the pill again.

But is it the best method for her?How effective is the combined oral contraceptive for prevention of pregnancy?

Typical use Perfect use24Perfect use is not the same as typical use. Methods which are most effective require the least intervention and perfect and typical use are closerNatural Family Planning Contraceptive MethodFailure RatePerfect UseTypical UseNo Method85%85%Periodic Abstinence Standard Days Method*5%12%Ovulation Method3%22%Symptothermal2%13-20%Two-Day Method 3%14%* Including Cycle BeadsNational Center Health Statistics; Contraceptive Technology25Barrier Methods Contraceptive MethodFailure RatePerfect UseTypical UseWithdrawal4 %18 %Condoms2 %17 %Cervical Cap (parous/nullip)26%/9%32%/16%Sponge (parous/nulliparous)20%/9%32%/16%Female Condoms5 %27 %Diaphragm6 %16 %National Center Health Statistics; Contraceptive Technology26Hormonal Methods Contraceptive MethodFailure RatePerfect UseTypical UseCombined Hormonal Pills 5 B-S episodes in 90-day period18% prolonged: at least 1 B-S episode > 14 days20% have B-S for >50 days in first 90-day periodGenerally NOT heavy

Weight: minor changes (2.3%)Mean weight gain = 3.7 lbs at year 2Blumenthal Eur J Contracept Reprod Health Care, 2008 Mansour Eur J Contracept Reprod Health Care 2008.

6140% with irregular bleeding mostly spottingTalking Points:In clinical studies, the bleeding patterns reported include those listed here. Notably, there is a risk of unscheduled bleeding or irregularly irregular cycles. This non-patterned bleeding should be discussed with women prior to insertion to minimize discontinuation. Amenorrhea was more common with use of a single-rod than a multiple-rod implant.

References: Affandi B. An integrated analysis of vaginal bleeding patterns in clinical trials of Implanon.Contraception 1998;58:99S-107S.Zheng SR, Zheng HM, Qian SZ, et al. A randomized multicenter study comparing the efficacy and bleeding pattern of a single-rod (Implanon) and a six-capsule (Norplant) hormonal contraceptive implant. Contraception 1999;60:1-8.Irregularly irregular cycles, including:Frequent irregular bleedingHeavy menstrual flowProlonged bleedingAmenorrheaSpottingUnpredictability of bleeding pattern over timeNo anemia

Implant: Bleeding TreatmentEstrogen reduces number of bleeding days with 6-rod implant (and DMPA)50 mcg Ethinyl Estradiol x 14-21 dMifepristone reduces number of daysPlus 20 mcg EE NSAIDS mixed resultsIbuprofen 800mg po TID x 5 dMefenemic acid 500 mg po BID x 5 dAspirin 80 mg po qd x 10 d

I recommend 1) Ibuprofen 2) 30 mcg COC or higher dose ERT

6240% with irregular bleeding mostly spottingTalking Points:In clinical studies, the bleeding patterns reported include those listed here. Notably, there is a risk of unscheduled bleeding or irregularly irregular cycles. This non-patterned bleeding should be discussed with women prior to insertion to minimize discontinuation. Amenorrhea was more common with use of a single-rod than a multiple-rod implant.

References: Affandi B. An integrated analysis of vaginal bleeding patterns in clinical trials of Implanon.Contraception 1998;58:99S-107S.Zheng SR, Zheng HM, Qian SZ, et al. A randomized multicenter study comparing the efficacy and bleeding pattern of a single-rod (Implanon) and a six-capsule (Norplant) hormonal contraceptive implant. Contraception 1999;60:1-8.Irregularly irregular cycles, including:Frequent irregular bleedingHeavy menstrual flowProlonged bleedingAmenorrheaSpottingUnpredictability of bleeding pattern over timeNo anemia

Every 5-10 Years: Intrauterine Devices (IUD, IUC, IUD, IUS)Levonorgestrel Intrauterine System (LNG-IUS)Levonorgestrel 20 mcg/day0.1% failure (1 yr) 1.1% (7 yr)

Copper T 380A IUD 0.8% failure (1 yr) 1.2% failure (7 yr) Lockhat Fertil Steril, 2005Comparable to BTL failure rate of 1.8% /10 yrs10 years5 years63Copper T IUD:Currently marketed as ParaGard by FEI Womens Health, Inc.T-shaped polyethylene and copper unit.Approved for 10 years of use, data demonstrate 12 year efficacy. Approved by the FDA in 1984, marketed in 1988.LNG IUS:Currently marketed as Mirena by Berlex, Inc.Approved for 5 years of use, data demonstrate 7 year efficacy.Approved by the FDA in 2000; has been used in Europe since 1990. A progesterone-releasing IUD (Progestasert) was on the market in the US from 1976 until 2001. Worldwide Use of IUD

Population Reference Bureau, 2002.Asia%UsingIUDEuropeLatin America& CaribbeanAfricaOceaniaNorthAmerica64IUD is the most popular form of reversible contraception used worldwide, but its use remains limited in North America.

The population listed here, women currently married or in union using family planning, age 15 49, is the population that is most suited for IUD use, but only a very small percentage of women in North America use IUD.Among all contraceptive users in the U.S., IUD is used far less often (0.7% of women) than sterilization (23.8% of females, 13.2% of males) . The opposite is true in other countries.

Reference:Population Reference Bureau. Family Planning Worldwide 2002 Data Sheet. 2002.IUD ReviewCurrent IUDs do NOT cause PID!!!Transient increased risk at time of insertionSTI at time of insertion increases riskGC/CT screening can follow CDC guidelinesOkay to screen on insertion day treat if +Beyond time of insertionOverall decreased risk with LNG IUS No increased risk with Copper IUDOkay to treat for PID with IUD in place

Svensson L, et al. JAMA. 1984; Sivin I, et al. Contraception. 1991.Farley T, et al. Lancet. 1992; Hubacher, NEJM, 2003.65Rate of PID by Duration of Use

Rate per 1000 Woman-Years20 days21 days - 8 yearsn=20,000 women.Adapted from Farley T, et al. Lancet. 1992;339:785-788.Baseline PID risk:1-2 cases /TWYDurationLonger duration of IUD 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 IUD 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.IUDs in Nulliparous WomenUse by nulliparous women is safe and effective1-4LNG-IUS is appropriate for nulliparous women with menorrhagia and/or dysmenorrheaIUD expulsion, bleeding, and pain are slightly more likely among nulliparous women2-5Suhonen S. Contraception 2004;69:507-512Nelson AL. Obstet Gynecol Clin North Am. 2000;27:723-740 Dardano KL, Burkman RT. Am J Obstet Gynecol. 1999;181:1-5Li C. Contraception 2004;69:247-250Treiman K, et al. Population Reports. 1995

67IUDs: For Nulliparous WomenIUDs are appropriate for many nulliparous women who are at low risk for STDs.Use of IUDs for nulligravid women with low risk of PID is as safe and reliable as among parous women.1-3The levonorgestrel-releasing IUDs may be more appropriate for nulliparous women with menorrhagia and/or dysmenorrhea.IUD expulsion, bleeding, and pain are slightly more likely among nulliparous women than among women who have had children.2-5 Correct insertion, with the IUD placed up to the fundus, is thought to reduce the likelihood of expulsion.4Sources:Suhonen S, Haukkama M, Jackobsson T. Clinical performance of a levonorgestrel-releasing intrauterine system and oral contraceptives in young nulliparous women: a comparison study. Contraception. 2004;69:507-412.Nelson AL. The intrauterine contraceptive device. Obstet Gynecol Clin North Am. 2000;27:723-40. Dardano KL, Burkman RT. The intrauterine contraceptive device: an often-forgotten and maligned method of contraception. Am J Obstet Gynecol.1999;181:1-5;Li C-FI, Lee SNN, Pun TC. A pilot study of the acceptability of levonorgestrel-releasing intrauterine device by young, single, nulliparous Chinese females following surgical abortion. Contraception 2004;69:247-250.Treiman, K., L. Liskin, A. Kols, and W. Rinehart. "IUDsAn Update." Population Reports, Series B, no. 6 (December 1995). Available from Population Information Program, Johns Hopkins University, 327 St. Paul Street, Baltimore, MD 21208. Treiman K, et al. Population Reports. 1995.

IUD & Vaginal BleedingStudy Group Mean Blood Loss (mL)Control35Paragard 50-80Mirena5

After 12 mos: average 90% decrease bloodIncreased spotting common in first 3-6 months50% have amenorrhea by 1 yearSperoff & Darney Clinical Guide for Contraception 200568Is Jane a candidate for an IUD?

Women of any reproductive age seeking long-term, highly effective contraception 69Cost-effective if use for 1 year or moreImmediate return to fertility can think of as reversible sterilizationDo not limit based on number of sexual partners, monogamous

Postpartum Intrauterine Contraception2010 US MEC: Postpartum IUD InsertionPostpartum (BF or non-BF women) including post-caesarean sectionLNG-IUD

Cu-IUD