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Using the Best Evidence to Select the Best Contraceptive

Using the Best Evidence to Select the Best Contraceptive . Jody Steinauer, MD, MAS Dept. Ob/ Gyn & Reproductive Sciences University of California, San Francisco. Disclosure Statement. I have nothing to disclose. Do you place intrauterine contraception in your clinical practice? Yes No.

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Using the Best Evidence to Select the Best Contraceptive

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  1. Using the Best Evidence to Select the Best Contraceptive Jody Steinauer, MD, MAS Dept. Ob/Gyn & Reproductive Sciences University of California, San Francisco

  2. Disclosure Statement I have nothing to disclose.

  3. Do you place intrauterine contraception in your clinical practice? • Yes • No

  4. How comfortable would you be offering a woman an IUD if she had a history of Chlamydia and no current infection? • Very comfortable • Somewhat comfortable • Uncomfortable

  5. Would you offer a 20 year-old woman with migraine the combined oral contraceptive? • Yes • It depends • No

  6. Objectives Remember 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.

  7. 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.

  8. 6.4 Million US Pregnancies Annually 48 % Unintended 52 % Intended Jones PSRH 2008

  9. 6.4 Million U.S. Pregnancies Annually 25 % Unintended Despite method use 52 % Intended 23 % Unintended No method used Henshaw Family Planning Perspectives, 1998

  10. Why 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 couldn’t call in refills. Today was the first day she could get an appointment.

  11. Provider Barriers to Contraception • Clinical Visit • BP check to initiate estrogen-containing methods • No pap smear or other examination • Refill methods without seeing patient • Remember birth control • 48% using D or X rx counseled on contraception1 • Knowledge about contraindications • US guidelines Schwarz Ann Intern Med, 2007.

  12. Case: Counseling Issues After 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?

  13. Can my patient use this method? • WHO Medical Eligibility Criteria (MEC) • www.reproductiveaccess.org • www.who.int

  14. Birth control methods Medical conditions MEC Category

  15. US MEC: 2010 Current WHO MEC contains > 1800 recommendations No need to adapt most recommendations Science is the same Recommendations are used around the world CDC accepted majority of WHO recommendations Adapted a few for the US context

  16. 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

  17. US MEC: 2010 Existing WHO guidance • Breastfeeding and CHC • Breastfeeding and progestin‑only methods • Postpartum IUDs • Ovarian cancer and IUDs • Fibroids and IUDs • DVT/PE and hormonal contraception • Valvular heart disease and IUDs New medical conditions • Rheumatoid arthritis • Endometrial hyperplasia • Inflammatory bowel disease • Bariatric surgery • Solid organ transplantation • Peripartum cardiomyopathy

  18. Migraine and Combined Hormonal Contraception (CHC)

  19. Migraine, COC*, and Stroke Synergistic effect of Migraine and COC OR 8.7 (95% CI 5.0-15.0)1 OR 13.9 (95% CI 5.5-35.1)2 *COC= combined oral contraceptive pills Etminan BMJ, 2005. Tzourio BMJ, 1995.

  20. WHO/US: Headaches and CHC* Non-migrainous1 Migraine (i) w/o focal neurologic symptoms Age < 35 2 Age > 35 3 (ii) w/ focal neurologic symptoms 4 (at any age) Focal symptoms = AURA = vision changes, numbness, parasthesias Non-focal = Prodrome, photo/phonophobia, N/V

  21. WHO/US: Headaches and CHC* Initiate Continue Non-migrainous1 2 Migraine (i) w/o focal neurologic symptoms Age < 35 2 3 Age > 35 3 4 (ii) w/ focal neurologic symptoms 4 4 (at any age) Focal symptoms = AURA = vision changes, numbness, parasthesias Non-focal = Prodrome, photo/phonophobia, N/V

  22. Absolute Risk of Stroke • Stroke in pregnancy: 34 per 100,000 ♀ / year Speroff & Darney Clinical Guide for Contraception 2005

  23. Case: Counseling Issues After reviewing the US and WHO MEC you decide Jane could use the pill again. But is it the best method for her?

  24. How effective is the combined oral contraceptive for prevention of pregnancy? Typical use ≠ Perfect use

  25. Natural Family Planning * Including Cycle Beads National Center Health Statistics; Contraceptive Technology

  26. Barrier Methods National Center Health Statistics; Contraceptive Technology

  27. Hormonal Methods National Center Health Statistics; Contraceptive Technology

  28. Realities of Pill Use There are many barriers such as limitations on number of pill packs dispensed.

  29. Realities of Pill Use 1996 Percent of Women (%) Active Pills Missed Potter FamPlannPerspect, 1996

  30. Realities of Pill Use 2010 Mean Pills Missed Cycle Hout et al ACOG, September 2010

  31. Contraceptive Method Use in US, 2006-2008 28% 5.5% *Other includes cervical cap, foam, female condom, and EC Alan Guttmacher Institute, Facts In Brief, 2010.

  32. Contraceptive Method Use in US, 2006-2008 10 million women *Other includes cervical cap, foam, female condom, and EC Alan Guttmacher Institute, Facts In Brief, 2010.

  33. Contraceptive Methods: Old Approach to Counseling • Natural Family Planning • Barrier Methods • Hormonal Methods

  34. Contraceptive Methods: Old Approach to Counseling • Natural Family Planning • Barrier Methods • Hormonal Methods • New: Focus on highest efficacy

  35. http://www.fhi.org/nr/shared/enFHI/Resources/EffectivenessChart.pdfhttp://www.fhi.org/nr/shared/enFHI/Resources/EffectivenessChart.pdf

  36. Counseling: Frequency of Intervention • Permanent: sterilization • Every 10 years: IUD • Every 5 years: IUD • Every 3 years: implant • Every 3Months: injection • Monthly: vaginal ring • Weekly: patch • Daily: pill, NFP • Episodic: barrier methods, NFP Increasing efficacy

  37. Daily: Natural Family Planning • Help women identify fertile days • Fertility window 6-8 days • Failure rate 12-22% • Two-day method® • Simple, accurate method – quicker to learn • Two questions • Did I note secretions today? • Did I note secretions yesterday? • If yes to either, consider fertile

  38. Natural Family Planning: Two-day Method® • Study of 450 women – 3,928 cycles • Failure rates: • 14% typical use • 3% perfect use (no intercourse) • 6% semi-perfect (barriers or withdrawal) • Half of pregnancies in first 3 months • Mean fertile window 12 days • High acceptability Arevalo, Fertil Steril, 2004.

  39. Daily: Combined Oral Contraceptives • Traditional prescription flawed • Extended cycle may ↑efficacy • 47% - follicle > 10 mm at day 7 of placebo week! • If delay in new pack may ovulate! Baerwald, Contraception, 2004.

  40. Extended Cycle: Shortened hormone-free week • 23, 24 or 26 days hormones + 2-5 d placebo • Decreased ovarian activity at end of placebo • Shorter withdrawal bleeds • Similar breakthrough bleeding • 3 FDA-approved products in US • New quadriphasic pill – 2 d E, 22 d E+P, 2d E • Start on cycle d 1; backup x 9 d SponaContraception, 1996 Bachman Contraception, 2004 EndrikatContraception, 2001.

  41. Extended Cycle:Fewer hormone-free weeks • 12 wks hormone/1 wk off • Ethinyl estradiol and levonorgestrel • 84 days LNG 150 µg/EE 30 µg; 7 days placebo • Decreased breakthrough bleeding over time Anderson Contraception, 2003

  42. Tricycle Breakthrough Bleeding/Spotting Anderson FD, et al., Contraception, 2003.

  43. Extended Cycle: Continuous Use • Continuous for one year • Increased spotting in first six months • Median 1.5 days spotting in last trimester • FDA-approved: ethinyl estradiol and levonorgestrel • 90 mcg levonorgestrel + 20 mcg EE Miller Obstetrics and Gynecology, 2003. Kwiecen, Contraception, 2003. Foidart, Contraception, 2006.

  44. Choosing a COC • Estrogen dose • Low dose = < 50 mcg • Progestin type • 1st-generation: norethindrone • Second-generation: levonorgestrel • Third-generation: desogestrel • Drospirenone: spironolactone derivative • VTE risk • Increased risk with 3rd generation progestin • OR= 1.7 (1.4-2.0) • Increased risk with drospirenone • OR = 1.64 (1.27 to 2.10) KemmerenBMJ 2001; LidegaardBMJ 2009

  45. Choosing a COC • Careful with very low-dose estrogen – ↑ bleeding • Monophasic fine • No drospirenone • Increased risk VTE • PMDD: fewer sxs 6 months – equivalent at 2 yr • Acne: Equivalent to other pills • 30 or 35 mcg EE + 2nd generation progestin • Shortened or erased placebo week if possible • Monophasic VanViet Cochrane 2006 LaGuardia Contraception, 2003 Freeman Womens Health 2001 van VlotenCutis 2002

  46. Jane no longer wants to take a pill every day. She asks you about other birth control methods which she doesn’t have to think about as often. What can you offer her? Weekly 5-10 years 3 months Monthly 3 years

  47. Daily:Progestin-only Pills (POPs) • 35 mcg norethindrone DAILY • No hormone free interval!! • Primary mechanism = cervical mucus thickening • Requires very punctual dosing • If > 3 hours late, need back up x 48 hours

  48. Weekly:Transdermal Contraception “Patch” • Norelgestromin and EE • 20mcg EE & 150mcg norelgestromin • One patch each week for 3 weeks, then week off • Better compliance than with pill (88% v. 78%) AudetJAMA, 2001

  49. Weekly: Patch • Few side effects – comparable to pills except: • 20% skin irritation – 2% stopped method • More breast discomfort in first 2 cycles (19%) than pills (6%) • More spotting (20%) than pills in first 2 cycles • 3% detached – recent RCT 46% experience at least one detachment in one cycle • Prescribe replacement patch CreininObstetGynecol 2008

  50. Patch and VTE*2 studies, 2 results Case control studies from insurance claims. Patch vs. 35mcgEE/norgestimate No association:1,2 59K patch & 147K OC users Risk of non-fatal VTE: OR=0.9 (CI 0.5–1.6) 1 OR=1.1 (CI 0.6–2.1) 2 • All were new users • No chart review Association:3 99K patch & 257K OC users Risk of non-fatal VTE: OR=2.4 (CI 1.1-5.5)3 • New users: OR=2.2 (0.8-6.1) • Charts reviewed 1.Jick SS Contraception 2006; 2. Jick SS Contraception 2007 3. Cole JA ObstetGynecol 2007 Better study supports increased risk.

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