Complex contraception Jennifer Kerns, MD, MPH Assistant Professor, - - PowerPoint PPT Presentation

10/14/2015 1

Complex contraception

Jennifer Kerns, MD, MPH Assistant Professor, UCSF Obstetrics, Gynecology and Reproductive Sciences San Francisco General Hospital October 2015

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

▫ Contraceptive counseling techniques ▫ Contraception for obese women ▫ Choosing the best COC ▫ Emergency contraception ▫ Unscheduled bleeding with nexplanon ▫ Updates: Liletta, Essure

Contraceptive Prevalence & Maternal Deaths

Ahmed et al. Lancet. 2012

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Benefits of avoiding unintended pregnancy

Frost and Lindberg Contraception 2012

• A. Yes
• B. No

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

Y e s N

• 38%

62%

Can my patient use this method?

1. CDC Medical Eligibility Criteria (CDC MEC)

• 2. U.S. Selected Practice Recommendations (US SPR)

for Contraceptive Use, 2013

• 3. ACOG Practice Bulletin No. 73
• 4. Contraception for the Medically Challenged Patient,

Rebecca Allen, Carrie Cwiak et al.

Just google this

CDC Medical Eligibility Criteria (MEC)

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MEC Categories

1 Can use the method No restrictions 2 Can use the method Advantages generally

• utweigh

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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Maya

• Maya is a 23 yo G5P2
• 6 weeks post-abortion
• Interested in contraception.
• 2 NSVDs, 2 abortions
• BMI = 41

Approaches to counseling?

• Information transfer
• Provider recommendation
• Allowing patient to decide
• Shared decision making

Information transfer Provider recommendation Shared decision making Patient makes her decision

• Paternalistic
• Coercion
• LARC promotion
• Passive
• Unresponsive

Preference-sensitive decision shared decision making

• SDM means the provider does not insert her/his

values into the counseling

• Counseling influences method selection
• Quality of family planning care associated with

use of contraception and satisfaction with method

• Patient-centeredness is the right thing to do

Elwyn et al. Ann Fam Med 2014 Dehlendorf et al. Contraception 2013 Durand et al. PLoS One 2014

• A. True
• B. False

Combined hormonal methods are considered safe for obese women

Obesity and contraception

True False

10% 90%

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Safety of combined hormonal methods in obese women

• CDC Medical Eligibility Criteria: 2
• Venous thromboembolism (VTE) risk increased:

▫ No evidence of synergistic effect ▫ Risk is less than that of pregnancy (29/10,000 ♀yrs) ▫ No data on women with BMI>40

• No increased risk of Acute MI or stroke

Safety of other methods in obese women

• CDC Medical Eligibility Criteria: 1, except…
• DMPA in obese adolescents = 2
• A. True
• B. False

Combined hormonal methods have similar efficacy in obese women compared to non-obese women

Obesity and contraception

T r u e F a l s e

58% 42%

Obesity and oral contraceptives

• YES (we think) – conflicting data for COCs

Dinger et al. Obstet Gynecol 2011 McNicholas et al. Obstet Gynecol 2013 Lopez et al. Cochrane 2010

• N>52,000
• RR 1.5 failure / BMI>35
• N=1500
• RR=1 failure (underpowered)
• Longer time to steady state

(10 vs 5 days)

• May be related to dosing

(incr risk with prolonged pill-free interval)

• Overall risk of failure still low
• Can consider continuous dosing

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Obesity and other methods

• Ring: same efficacy
• Implant: same efficacy
• IUDs: same efficacy
• Patch: decreased in women >90kg

Dinger et al. Obstet Gynecol 2011 McNicholas et al. Obstet Gynecol 2013 Lopez et al. Cochrane 2010

Back to Maya… What other obesity- related conditions does she have?

• Diabetes?

▫ Only contraindicated (MEC 3, 4) for all methods if

End-organ disease, or >20 yrs duration

• Multiple cardiovascular RFs? (age, htn, smoking, DM)

▫ Pill, patch, ring, DMPA contraindicated ▫ Room for clinical judgment re: what constitutes multiple RFs

CDC medical eligibility criteria

Maya’s contraceptive choice: COCs

Apri, Azurette, Caziant, Cesia, Cyclessa, Desogen, Emoquette, Kariva, Mircette, Ortho-Cept, Reclipsen, Solia, Velivet, Viorele, Natazia, Gianvi, Loryna, Ocella, Syeda, Vestura, Yasmin, Yaz, Zarah, Beyaz, Safyral, Kelnor, Zovia 1/35, Zovia 1/50, Altavera, Amethia, Amethia Lo, Amethyst, Aviane, Camrese, Camrese Lo, Daysee, Enpresse, Introvale, Jolessa, Kurvelo, Lessina, Levlite, Levora, LoSeasonique, Lutera, Lybrel, Marlissa, Myzilra, Nordette, Orsythia, Portia, Quartette, Quasense, Seasonale, Seasonique, Sronyx, Triphasil, Trivora, Necon 1/50, Norinyl 1/50, Alyacen 1/35, Alyacen 7/7/7, Aranelle, Balziva, Brevicon, Briellyn, Cyclafem 1/35, Cyclafem 7/7/7, Dasetta 1/35, Dasetta 7/7/7, Estrostep Fe, Femcon Fe, Generess Fe, Gildagia, Gildess Fe, Junel 21 1.5/30, Junel 21 1/20, Junel Fe 1.5/30, Junel Fe 1/20, Leena, Loestrin 21 1.5/30, Loestrin 21 1/20, Loestrin 24 Fe, Lo Loestrin Fe, Loestrin Fe 1.5/30, Loestrin Fe 1/20, Microgestin 1/20, Microgestin 1.5/30, Microgestin Fe 1/20, Microgestin Fe 1.5/30, Modicon, Necon 0.5/35, Necon 1/35, Necon 10/11, Necon 7/7/7, Norinyl 1/35, Nortrel 0.5/35, Nortrel 1/35, Nortrel 7/7/7, Ortho-Novum 1/35, Ortho-Novum 7/7/7, Ovcon 35, Ovcon 50, Philith, Tilia Fe, Tri-Legest Fe, Tri-Norinyl, Wera, Zenchant, Zenchant Fe, Zeosa, Estarylla, Mono-Linyah, MonoNessa, Ortho Tri-Cyclen, Ortho Tri-Cyclen Lo, Ortho-Cyclen, Previfem, Sprintec, Tri-Estarylla, Tri-Linyah, Tri-Previfem, Tri-Sprintec, TriNessa, Cryselle, Elinest, Lo/Ovral-28, Low-Ogestrel, Ogestrel

Progestin choice

• Levonorgestrel lowest risk of VTE
• Remember. . . Absolute risk remains low
• Balance with patient choice
• No clear benefit of drospirenone with PMDD, acne
• Non-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

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Maya’s contraceptive choice: COCs

Levonorgestrel-containing COCs

Apri, Azurette, Caziant, Cesia, Cyclessa, Desogen, Emoquette, Kariva, Mircette, Ortho-Cept, Reclipsen, Solia, Velivet, Viorele, Natazia, Gianvi, Loryna, Ocella, Syeda, Vestura, Yasmin, Yaz, Zarah, Beyaz, Safyral, Kelnor, Zovia 1/35, Zovia 1/50, Altavera, Amethia, Amethia Lo, Amethyst, Aviane, Camrese, Camrese Lo, Daysee, Enpresse, Introvale, Jolessa, Kurvelo, Lessina, Levlite, Levora, LoSeasonique, Lutera, Lybrel, Marlissa, Myzilra, Nordette, Orsythia, Portia, Quartette, Quasense, Seasonale, Seasonique, Sronyx, Triphasil, Trivora, Necon 1/50, Norinyl 1/50, Alyacen 1/35, Alyacen 7/7/7, Aranelle, Balziva, Brevicon, Briellyn, Cyclafem 1/35, Cyclafem 7/7/7, Dasetta 1/35, Dasetta 7/7/7, Estrostep Fe, Femcon Fe, Generess Fe, Gildagia, Gildess Fe, Junel 21 1.5/30, Junel 21 1/20, Junel Fe 1.5/30, Junel Fe 1/20, Leena, Loestrin 21 1.5/30, Loestrin 21 1/20, Loestrin 24 Fe, Lo Loestrin Fe, Loestrin Fe 1.5/30, Loestrin Fe 1/20, Microgestin 1/20, Microgestin 1.5/30, Microgestin Fe 1/20, Microgestin Fe 1.5/30, Modicon, Necon 0.5/35, Necon 1/35, Necon 10/11, Necon 7/7/7, Norinyl 1/35, Nortrel 0.5/35, Nortrel 1/35, Nortrel 7/7/7, Ortho- Novum 1/35, Ortho-Novum 7/7/7, Ovcon 35, Ovcon 50, Philith, Tilia Fe, Tri-Legest Fe, Tri-Norinyl, Wera, Zenchant, Zenchant Fe, Zeosa, Estarylla, Mono-Linyah, MonoNessa, Ortho Tri-Cyclen, Ortho Tri-Cyclen Lo, Ortho-Cyclen, Previfem, Sprintec, Tri-Estarylla, Tri-Linyah, Tri- Previfem, Tri-Sprintec, TriNessa, Cryselle, Elinest, Lo/Ovral-28, Low- Ogestrel, Ogestrel

Ethinyl estradiol dose

• Nearly all modern-day OCs are “low-dose”
• 30mcg EE higher continuation (vs. 20mcg EE)
• Monophasic
• Option to shorten or eliminate placebo week

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

• a. Ulipristal (Ella)…

levonorgestrel (Plan B)… Copper IUD

• b. Copper IUD…

ulipristal… levonorgestrel

• c. Levonorgestrel…

Copper IUD… ulipristal

3 months later… Maya returns asking for emergency contraception because she missed pills

Choose the answer that lists the EC methods in

• rder of most effective to least effective

Oral Emergency Contraception

LNG: 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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29

Levonorgestrel less effective for obese women

Glasier A et al. Contraception. 2011. Misinformation about LARC

Percent of women pregnant after taking LNG pills

Emergency contraception

• Used shared decision making for contraceptive

counseling

• Reviewed evidence of safety/ efficacy of

contraception in obese women

• Used evidence to choose the best COC
• Considered obesity in EC recommendation
• Gave her resources – BEDSIDER!

Summarizing Maya’s visit

• Discontinuation common, largely because of

unscheduled bleeding

• Nearly 80% of women report some unscheduled

bleeding with ETG implant

Etonogestrel implant and unscheduled bleeding

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• First 3 months predicts future (but not perfectly)

▫ Those w/ favorable bleeding are likely to continue to have favorable bleeding ▫ Those w/ unfavorable bleeding have a 50% chance

• f improving
• Management:

▫ Expectant ▫ NSAIDs (400-800mg TID, 5-10 days) ▫ COCs (cyclic) ▫ Estrogen (oral conjugated, estradiol, transdermal) ▫ Tamoxifen, mifepristone, doxycycline

Etonogestrel implant and unscheduled bleeding

• Low-cost Mirena
• FDA-approved for 3 years

▫ effective 5-7, just like Mirena

• No increase in pricing until 2017

▫ Title X clinics - $50 ▫ Rebate from company if patient pays full price

Liletta

• Pre-marketing studies

▫ 2 non-blinded, non-randomized studies w/ no comparator group ▫ Analysis was not intention to treat, and 15% had failed attempts at placement ▫ Only 85% followed up at 1 yr for effectiveness (and 25% at 2 yrs) ▫ 71% followed out to 5 yrs: no pregnancies reported

• Post-marketing studies

▫ Stopped early, no follow up, all results redacted on FDA website

• Reports to MAUDE database

▫ 5093 reports made: incomplete procedures, chronic pain, device migration, tubal perforation, bleeding, pregnancies

• ~ 5.7% annual risk of pregnancy estimated

Essure update

Dhruva et al. NEJM 2015

Conclusions

• Contraception is integral to public health
• Counseling should be patient-centered
• Resources are at your fingertips to help you

decide which methods are safe for your patient!

▫ Including the UCSF family planning pager… (415) 443-6318