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Complex contraceptionJennifer Kerns, MD, MPHAssistant Professor, UCSFObstetrics, Gynecology and Reproductive SciencesSan Francisco General HospitalOctober 2014

Disclosures• I have no relevant financial disclosures

Objectives• To review resources for assessing the safety of contraceptive methods for particular women

• To review the evidence for selected practice recommendations for women with particular medical issues

• To emphasize the need for contraception especially for medically complicated women

Contraceptive Prevalence & Maternal Deaths

Ahmed et al. Lancet. 2012

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Are you familiar with the US Medical Eligibility Criteria for Contraception?

a. b.

16%

84%

a. Yesb. No

Are you familiar with the US Selected Practice Recommendations for Contraception?

a. b.

42%

58%a. Yesb. No

Can my patient use this method?

CDC Medical Eligibility Criteria• Evidence-based guidelines for safety of methods with co-existing conditions

• Similar to WHO but US-specific www.cdc.gov/mmwr/preview/mmwrhtml/rr59e0528a1.htm

CDC Medical Eligibility Criteria (MEC)

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MEC Categories1 Can use the method No restrictions2 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

Medical Condition

Birth Control Methods

MEC Category

Where do you find the US MEC?

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ACOG Resource New Textbook

Case #119 yo G0, newly sexually active, wants to start the contraceptive vaginal ring. But she is concerned about what she has read in the news about the ring causing blood clots.

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DVT Risk with the Contraceptive Vaginal Ring (CVR)• Retrospective cohort: 9,429,128 woman years• Confirmed VTE events per 10 000 woman years▫ Non-users of hormonal contraception 2.1▫ Combined Oral Contraceptives 6.2 (RR 3.2)▫ Transdermal patches 9.7 (RR 7.9) ▫ Vaginal ring 7.8 (RR 6.5)

Ring +1.6 additional cases / 10,000 women-years. Adjusted Rate Ratio 1.9 (1.3-2.7) v. COC

Lidegaard et al. BMJ 2012

DVT Risk with the Contraceptive Vaginal Ring (CVR)

• Prospective cohort - 66 489 woman years of observation• Confirmed VTE events per 10 000 woman years▫ LNG COC 7.8▫ All COC 9.2▫ Vaginal ring 8.3

Ring - no increased risk compared with any pill. HR 0.8 (0.5-1.5)

Dinger et al. Obstet Gynecol 2013

DVT Risk with the Contraceptive Vaginal Ring (CVR)• Retrospective cohort - 573, 680 women• Confirmed VTE events per 10 000 woman years▫ All COC – new users 8.2 (7-9.6)▫ Vaginal ring 11.3 (4.26-32)

Ring - no increased risk compared with the pill (after adjustment)HR 1.1 (0.6-2.2)

Sidney et al. Contraception 2013

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Case #119 yo G0, newly sexually active, wants to start the

contraceptive vaginal ring. • Conflicting level 2 evidence – may cause slight

increase risk relative to COC• Attributable risk = very, very small• Level I evidence that women use it correctly

compared with pill• May cause fewer unintended pregnancies and

therefore fewer VTE overall

VTE & Oral Progestin Type• Desogestrel and drosperinone COCs may increase risk of VTE

• BUT. . . Absolute risk remains lowNon-pregnant, no COCs: 2-4 per 10,000 ♀- yrs• Levonorgestrel COCs: 5.0 per 10,000 ♀- yrs• Desogestrel COCs: 6.5 per 10,000 ♀- yrs• Drosperinone COCs: 7.8 per 10,000 ♀- yrs

Lidegaard BMJ 2009 Heinemann Contraception 2007

Choosing a COC• Careful with very low-dose estrogen – ↑ bleeding• Monophasic fine• Levonorgestrel may cause fewer VTE• No clear benefit of drospirenone▫ PMDD: fewer sxs 6 months – equivalent at 2 yr▫ Acne: Equivalent to other pills

• 30 or 35 mcg EE + levonorgestrel• Shortened or erased placebo week if possible• Monophasic

VanViet Cochrane 2006LaGuardia Contraception, 2003Freeman Womens Health 2001van Vloten Cutis 2002

CDC MEC

All progestin-only methods are safe even if:

1) Current VTE2) No anti-coagulation3) Provoked or unprovoked VTE

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Case #238 yo G2P1T1 woman is seeking contraception.

She had pre-eclampsia during her last pregnancy but otherwise reports she is healthy.

Wt= 226 lbsHt= 5’5” (BMI = 37.6)

BP=138/89

Obesity and Contraception

Institute of Medicine. Weight gain in pregnancy: Reexamining the guidelines

Efficacy•Pharmacokinetics•Oral vs. non-oral•Risk of pregnancy

Adverse events•Risk of VTE•Risk of CV events•Metabolic effects

–Weight gain? Lipid profiles?

Obesity & Contraceptive Efficacy

1 Lopez LM Cochrane 2010 2 McNicholas Obstet Gynecol 2013 3 Edelman Contraception, 20094 Westhoff Obstet Gynecol 2005 5 Zieman Fertil Steril 2002

DMPA: no difference1

Ring: no difference1,2

Implant: lower serum level, but still inhibitory1,4

IUC: no difference

OCs: no clear difference; longer time to steady state1,2

Patch: increased failure5 if >90kg• BUT BMI more relevant measure• No effect with BMI1,2

Obesity & Contraceptive Risks• VTE risk▫ COCs & obesity are independent risk factors for VTE� Obesity doubles risk of VTE

▫ No data show synergistic, increased risk ▫ Risk is lower than pregnancy (29/10,000 ♀-yrs)

Note: no safety information on women with BMI >40

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Contraception & Weight Gain• Pill, Patch, Ring: none or age-expected change1,2,3,6

• LNG-IUS: age-expected weight gain4

• ENG implant: minimal if any effect5

• DMPA:

1. O’Connell 2001 Contraception; 2. Gallo 2004 Obstet Gynecol; 3. Berenson AJOG 20094. Ronnerdag Acta Obstet Gynecol Scand 1999 5. Darney Fertil Steril 2009 6. Beksinka Contraception 20107. Pantoja Contraception 2010 8. Bonny Contraception 2010

Pantoja 2010

•Average 5-6 kg over 3-5yrs3,6•Baseline BMI:

•Nl and overwt = �risk7•No assoc for adolescents8

•Adolescents:•More pronounced wt gain5

•Early wt gain @ 6mo (>5%) predicts future wt gain8

BMI>30

BMI 25-30

BMI<25

Metabolic Syndrome• Constellation of findings which increase risk of CHD,

stroke, & type 2 DM

• 3 or more risk factors▫ Hypertension ▫ Insulin resistance▫ Central obesity▫ High triglycerides▫ Low HDL

≥130/85FBS ≥100Waist circumference ≥35”≥150 mg/dL≤ 50mg/dL

Metabolic Syndrome & ContraceptionLIPIDS CHC: �TGL, HDL, �LDL1

For PCOS, improved LDL/HDL ratio2

DMPA: transient worsening of lipids post-injection3

ENG Implant: � Chol, LDL, HDL4,5

BLOOD PRESSURE

OCP: 5% develop reversible HTN (7mm Hg)6

INSULIN RESISTANCE

No DM:• OCs, LNG-IUS, implant: No impact7

• Ring: improved IR in PCOS8

• DMPA: no effect9 vs. small increase in FBS (3mg/dL over 2yrs)10

For obese women: DMPA increased IR v. non-obese women+ DM:• DMPA: No RCTs. Increase in FBG 103-112• OCP: No increase in insulin requirement or end-organ damage11

1. Winkler 2009 Contraception 2. Falsetti 1995 Acta Obstet Gyn Scand 3. WHO 1993 Contraception4. Merki-Feld 2008 Clin Endocrinol 5. Inal 2008 Eur J Contr Reprod HC 6. Darney & Speroff 2005 Clin Guide for Contraception7. Grimes 2009 Cochrane 8. Battaglia 2009 Fertil Steril 9. Fahmy 1991 Contraception 10. Berenson 2011 Obstet Gynecol 11. Skouby 1984 Fertil Steril

CDC MEC

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Bariatric Surgery & Contraception• Advisable to wait 1-2 years after surgery

before planning pregnancy1• Fecundity & pregnancy rates often

increase after surgery2,3

▫ Especially in adolescents(13% vs. 6%)▫ Prevent unintended pregnancy

• Recommend non-oral methods for surgeries that impair GI absorption4

▫ Decreased absorption of OCPs1. ACOG Practice Bulletin 105, 20092. Merhi 2007 Fertil Steril3. Roeherig 2007 Obes Surg4. Mehri 2007 Gynecol Obstet Invest

CDC MEC

Oral absorption

Case #2

38 yo G2P1T1 obese woman desires birth control

• Assess for other risk factors• If none, all methods are safer than pregnancy• If smoker or other risk factors – may avoid CHC• DMPA – concern for insulin resistance and weight gain• For EC – recommend ulipristal acetate or Cu-IUD

Case #3An 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?

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Emergency Contraception Oral Emergency ContraceptionLNG: 120 mg x 1, up to 5 days

Ulipristal Acetate:• Selective progesterone receptor modulator• Mechanism:Delayed follicular rupture• Will not harm existing pregnancy• Dosing: 30mg, FDA-approved up to 5 days

1. Brache 2010 Hum Reprod

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EC pills (LNG) less effective for obese women

Glasier A et al. Contraception. 2011.

Misinformation about LARC

Percent of women pregnant after taking EC pills

Emergency contraception

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Case #423 yo G0 is interested in using an IUD.History of chlamydia in college.She has had 3 male partners in the past year.Do you screen her for GC/CT?

Can women who have no children use an IUD?

Yes!

Misinformation about LARC

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.

Some considerations…• Skyla (13.5mg LNG, 3yrs)• Pre-insertion pain medication• Paracervical block

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Can women with a history of STIs use an IUD?Yes! Past infections are not a contraindication to any method of contraception.

Misinformation about LARC

ACOG Practice Bulletin. Obstet Gynecol. 2005.Skjeldestad, et al. Contraception. 1996.Centers for Disease Control. MMWR. 2010.

CDC Medical Eligibility for Initiating Contraception

ConditionLNG-IUS or Copper IUD

Sexually Transmitted Infections

Current vaginitis 2

Current chlamydia, gonorrhea, or purulent cervicitis

4

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Can women with a history of PID use an IUD?Yes! Women with PID history can use IUDs.Active PID is a contraindication

Misinformation about LARC

ACOG Practice Bulletin. Obstet Gynecol. 2005.Skjeldestad F et al. Contraception. 1996.Centers for Disease Control. MMWR. 2010.

CDC Medical Eligibility for Initiating Contraception

ConditionLNG-IUS or Copper IUD

Pelvic inflammatory disease

Past PID, subsequent pregnancy 1

Past PID, no subsequent pregnancy

2

Current PID 4

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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

• Beyond time of insertion▫ Overall decreased risk with LNG IUS ▫ No increased risk with Copper IUD

Farley Lancet 1992Walsh Lancet 1998

Routine GC/CT screening not necessary

� Retrospective cohort, n=57,728 IUD insertions� Evidence-based STI screening, tx if + test

Sufrin et al Obstet Gynecol 2013

Among all women: Risk of PID

Non-screened = ScreenedOR= 1.05 (0.78, 1.43)

Among screened women:Risk of PID

Same day = Pre-insertionOR=0.99 (0.64, 1.54)

Women appropriately selected for non-screening

Most accurate screening time is day of insertion

Who should be screened?• CDC and USPSTF guidelines for GC/CT screening at IUD insertion▫ Annually if < 26 yo and sexually active▫ Any time if risk factors (new partner, sx’s, other STI)

• Screen on same day as insertion• No cases of PID when Planned Parenthood switched to same day screening

• No benefit to prophylactic antibioticsUSPSTF Am J Prev Med 2001 CDC MMWR #59 2010 Goodman Contraception 2008Grimes Contraception 1999

Conclusions• Contraception is important for women with medical problems

• There are many methods that are appropriate for any given medical problems

• Consult the appropriate resources to help guide contraception recommendations