10/29/10 1 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? a. Yes b. No
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10/29/10
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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?
a. Yes b. No
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How comfortable would you be offering a woman an IUD if she had a history of Chlamydia and no current infection?
a. Very comfortable b. Somewhat comfortable c. Uncomfortable
Would you offer a 20 year-old woman with migraine the combined oral contraceptive?
a. Yes b. It depends c. No
Objectives At the end of this talk you will be able to:
Remember to think about contraception in your clinical practice.
Find evidence about contraception for women with possible contraindications.
Instruct patients on correct method use
Encourage women to use longer-term contraceptive methods.
Address recent controversies and myths in newer contraceptive methods.
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Jane is a 27 year-old gravida 0 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.
6.4 Million US Pregnancies Annually
52 % Intended
48 % Unintended
Jones PSRH 2008
6.4 Million U.S. Pregnancies Annually
52 % Intended
25 % Unintended Despite method use
23 % Unintended No method used
Henshaw Family Planning Perspectives, 1998
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Why did Jane get pregnant?
Jane tells you that she ran out of birth control pills last month, and that she tried to call the office to get an appointment, but the receptionist told her she was overdue for a pap smear. Today was the first day she could get an appointment.
Provider Barriers to Effective Contraception
• Examination – Initiation:
• BP check for estrogen-containing methods • Otherwise NO exam required
– Refills: • Should not require pap smear to get refill!!
• Awareness about need for birth control – 48% using D or X rx counseled on contraception1
• Knowledge about contraindications – Contraceptive evidence – WHO and US Medical Eligibility Criteria
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?
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Can my patient use this method? WHO Medical Eligibility Criteria
(MEC) www.reproductiveaccess.org
www.who.int 1 Can use the method No restrictions 2 Can use the method Advantages generally
outweigh theoretical or proven risks.
3 Should not use method unless no other method is appropriate
Theoretical or proven risks generally outweigh advantages
4 Should not use method Unacceptable health risk
Medical conditions
Birth control methods
MEC Category
US MEC!
• Just released May, 2010 • Similar to WHO but with US-specific
modifications and updated evidence – Obesity and bariatric surgery – VTE – Breastfeeding and postpartum – Endometrial hyperplasia – Ovarian cancer – Valvular heart disease, cardiomyopathy, IBD, RA – transplants
• Permanent: sterilization • Every 10 years: IUC • Every 5 years: IUC • Every 3 years: implant • Every 3 Months: injection • Monthly: vaginal ring • Weekly: patch • Daily: pill, NFP • Episodic: barrier methods, NFP
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Daily: Combined Oral Contraceptives
• Traditional prescription flawed • Extended cycle may increase
efficacy – Up to 47% of women have follicle ready to ovulate by day 7 of placebo week! – So if the start of the new pack is delayed, they are at high risk!
Baerwald, Contraception, 2004.
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
Spona Contraception, 1996
Bachman Contraception, 2004
Endrikat Contraception, 2001.
Extended Cycle: Fewer hormone-free weeks
• 12 wks hormone/1 wk off – Failure 0.6% - Lower than conventional?
• Ethinyl estradiol and levonorgestrel – 84 days LNG 150 µg/EE 30 µg; 7 days placebo
• Modified ethinyl estradiol and levonorgestrel – adds 10 mcg EE during placebo – No improvement in bleeding
Anderson Contraception, 2003
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Extended Cycle: Continuous use
• Continuous for one year – Increased spotting in first six months,
comparable in second six months • Median 1.5 days spotting in last trimester
– Up to 72% amenorrhea at one year
– High acceptability
• FDA-approved: ethinyl estradiol and levonorgestrel – 90 mcg levonorgestrel + 20 mcg EE
Miller Obstetrics and Gynecology, 2003. Kwiecen, Contraception, 2003. Foidart, Contraception, 2006.
Extended Use Pills: Summary
• I strongly recommend moving away from traditionally prescribed oral contraceptives. – Shorten placebo week – Extended hormonal weeks
• 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)
Kemmeren BMJ 2001; Lidegaard BMJ 2009
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Choosing a COC • Very low-dose estrogen – increased bleeding • Monophasic, Bi- or triphasic? • Drospirenone?
– Increased risk VTE – PMDD: fewer sxs at 3 & 6 months – equivalent at 2 yr – Acne: Overall, studies show equivalent to other pills My initial approach:
30 or 35 mcg EE + 2nd generation progestin Shortened or erased placebo week if possible Monophasic
Pill Instructions * • Initiation:
– If Sunday or Quick Start – backup for 7 days – System for remembering
• Continuation: – If missed pills – see appendix slides
• Antibiotics: – Rifampin is the only antibiotic which reduces
efficacy of OCPs – Do not tell women to stop taking OCPs when
they are on an antibiotic!!
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
Monthly
3 months
3 years
5-10 years
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Weekly: Transdermal Contraception “Patch”
• Norelgestromin and EE – 20mcg EE & 150mcg
norelgestromin • One patch each week for 3
weeks, then week off • Constant serum levels • Improved compliance than
with pill (88% v. 78%)
Audet JAMA, 2001
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
1.Jick SS Contraception 2006; 2. Jick SS Contraception 2007 3. Cole JA Obstet Gynecol 2007
Case control studies from insurance claims. Patch vs. 35mcgEE/norgestimate
Better study supports increased risk.
Patch & Body Weight
• 3,319 patch users, 22,160 cycles
• 15 failures overall 0.8% failure – 7 of them wt>80Kg – 5 of them wt >90kg (<3% of total study population)
• Did not present BMI • Conclusion: less effective if wt>90kg (198 lbs)
Patch Instructions • Initiation:
– Prescribe replacement patches (up to 3) – If day other than first day menses – backup 7 days
• If patch detaches or pt. forgets to apply – see appendix slides
• No band-aids, tattoos, or decals on top of patch as this might alter absorption of hormones
• Smooth edges down when you first put it on • Avoid the same site 2 consecutive weeks
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Patch Instructions
• Location of patch should not be altered mid-week • Women should check the patch daily to make sure
all the edges remain closely adherent to skin • Single replacement patches are available through
pharmacists • Unlike pills, the time of day the patch is changed
doesn’t matter • Disposal: Fold over self. Place in solid waste. Do
not flush down toilet
Monthly: Contraceptive Vaginal Ring
• Ethinyl estradiol and etonogestrel – 15 mcg EE & 120 mcg desogestrel
• One ring each month: – Ring in vagina x 3 wks – Ring removed x 1 week
• Constant, low hormone levels
Miller Obstet and Gynecol, 2005.
Monthly: Ring
• Few side effects – comparable to pills except – Spotting: only 5% (significantly less in first
month)
– Discharge: 1% stop method
– Discomfort: 2.5% stop method
– Expulsion: recent RCT: 20% expelled at least once during 3-week period
Dieben Obstet Gynecol, 2002
Creinin Obstet Gynecol, 2008
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Monthly: Extended Cycle Ring
• RCT of 561♀: 4wk, 8 wk, 12 wk, continuous: – All regimens well-tolerated – Extended: ↓ bleeding days, spotting days
• Potential for use on a monthly basis – Serum levels for 35 days
I instruct patients to remove ring the last 3-4 days of the month
Miller Obstet Gynecol, 2005
Ring Instructions • Initiation:
– First five days of menses – if not backup x 7 days • The ring can be left in for up to 35 days • May remove up to 3 hours (not recommended) • If ring is out for more than 3 hours see
instructions in appendix slides • Always have two rings on hand in case one is lost • Rings may be stored at room temperature for up to 4
months • Disposal: Fold over self. Place in solid waste. Do
not flush down toilet.
Every 3 months: Progestin Injection
• Medroxyprogesterone acetate 150 mg IM – One injection every 12-13 weeks
• Very effective! – Typical use failure = 3%
• Side effects: – Delayed return to fertility (9-10 months) – Irregular bleeding, amenorrhea (50% at 1 yr) – Weight gain (5 lbs at 1 year, 16 lbs at 5 yrs)
• SQ low-dose (104 mg) version now available
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Progestin Injection & BMD • BMD decreases by 1-2% per year • FDA: limit to 2 yrs in young women.
– WHO & ACOG do not agree w/ this!! – No evidence of increased fractures – Reverses by 12 mo’s after discontinuation.
• No indication for DEXA • Weigh risks against risk of pregnancy
• Traditionally recommend caution after > 14 weeks from last DMPA injection – See SOGC algorithm in appendix slides
• WHO recommends 4-week grace period
Every 3 years: Single-Rod Implant
• Etonogestrel 60mcg/day
• Efficacy > 99%
• Very easy & well tolerated to insert
• 1 year continuation: 75%-90% – Reasons for discontinuation:
Bleeding (11-40%) Mood swings (10%) Weight gain (10%)
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Single-Rod Progestin Implant: Side Effects
• Bleeding: “Irregularly irregular” (40%): – Amenorrhea: 22% – 7% frequent: > 5 B-S episodes in 90-day period – 18% prolonged: at least 1 B-S episode > 14 days – 20% have B-S for >50 days in first 90-day period
• Weight: minor changes (2.3%) – Mean weight gain = 3.7 lbs at year 2
Every 5-10 Years: Intrauterine contraception (IUC, IUD, IUS)
Contraindications ?current VTE Active cervicitis or PID Distortion of uterine cavity
Severe anemia Wilson’s disease Copper allergy Active cervicitis or PID Distortion of uterine cavity
Permanent: Tubal Sterilization
• Postpartum salpingectomy
• Interval laparoscopic methods
** Hysteroscopic transcervical tubal sterilization – Nickel/Titanium coils inserted into
tubes – Scarring reaction leads to tubal
occlusion – Need back-up method x 3 months
then HSG
Failure risk 0.5-1.8% Increases over time Peterson Am J Ob Gyn 1996
Verseema Fertil Steril 2008
Emergency Contraception Update
• ↓ risk of pregnancy by 89% after unprotected sex
• Essentially no contraindications
• Does not harm an established pregnancy
• Available behind the counter if >= 17 years
• Can be effective up to 5 days after unprotected sex • No exam or pregnancy test required
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Emergency Contraception Update
Jane
• You counsel Jane about the other options available, emphasizing those with high efficacy that require less intervention. She ends up choosing a highly effective IUD which you place that same day.
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Summary
• Unintended pregnancy remains a common problem in the US
• Many effective methods available – Minimize barriers to contraception
• Provider, systemic, and patient – Encourage more effective methods – Remain up-to-date about contraceptive