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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
• www.cdc.gov/mmwr/preview/mmwrhtml/rr59e0528a1.htm
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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
Migraine, COCs*, and Stroke
Synergistic effect of Migraine and COCs
OR 8.7 (95% CI 5.0-15.0) 1 OR 13.9 (95% CI 5.5-35.1) 2
Etminan BMJ, 2005. Tzourio BMJ, 1995.
*COC= combined oral contraceptive pills
Absolute risk of stroke is low!!
No COC COC Healthy 6 per 100,000 ♀ /yr 12 per 100,000 ♀ /yr Migraine 12 per 100,000 ♀ /yr 19 per 100,000 ♀ /yr Migraine + aura 18 per 100,000 ♀ /yr 30 per 100,000 ♀ /yr
Stroke in pregnancy: 34 per 100,000 ♀ / year
Speroff & Darney Clinical Guide for Contraception 2005
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WHO: Headaches and CHC* Initiate Continue
Non-migrainous 1 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)
Non-focal = Prodrome, photo/phonophobia, N/V
Focal symptoms = vision changes, numbness, parasthesias *CHC = combined hormonal contraception
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?
How effective is the combined oral contraceptive for prevention of pregnancy?
Typical use ≠ Perfect use
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Realities of Pill Use
Potter Fam Plann Perspect, 1996
Perc
ent o
f Wom
en (%
)
Active Pills Missed
Contraceptive Method Use in US, 2006-2008 NSFG
Alan Guttmacher Institute, Facts In Brief, 2010.
*Other includes cervical cap, foam, female condom, and EC
5.5%
Only 7% of women at risk for unintended pregnancy do not use a method.
28%
Contraceptive Methods: Old Approach to Counseling
• Natural Family Planning • Barrier Methods • Hormonal Methods
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Natural Family Planning
Contraceptive Method Failure Rate
Perfect Use Typical Use
No Method 85% 85%
Periodic Abstinence
Standard Days Method®* 5% 12%
Ovulation Method 3% 22%
Symptothermal 2% 13-20%
Two-Day Method® 3% 14%
* Including Cycle Beads National Center Health Statistics; Contraceptive Technology
Barrier Methods
Contraceptive Method Failure Rate
Perfect Use Typical Use Withdrawal 4 % 18 % Condoms 2 % 17 % Cervical Cap (parous/nullip) 26%/9% 32%/16% Sponge (parous/nulliparous) 20%/9% 32%/16% Female Condoms 5 % 27 % Diaphragm 6 % 16 %
National Center Health Statistics; Contraceptive Technology
Hormonal Methods
Contraceptive Method Failure Rate
Perfect Use Typical Use Combined Hormonal Pills <1 % 8 % Progestin Only Pills <1 % 8 % Transdermal Patch <1 % 8 % Vaginal Ring <1 % 8 % 3-Month Injection <1 % 6 % Implants <1 % <1 % Copper IUD/LNG IUS <1 % <1 %
National Center Health Statistics; Contraceptive Technology
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Contraceptive Methods: Counseling
• Key points: – Focus on efficacy, ease of use
• Address pregnancy plans – Review side effects, protocols for use – Provide continuity of care and system for
questions
Improving Contraceptive Use in the US, Guttmacher Institute, 2008
http://www.fhi.org/nr/shared/enFHI/Resources/EffectivenessChart.pdf
Counseling: Frequency of Intervention
• 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
Choosing a COC • Estrogen dose
– Low dose = < 50 mcg
• Progestin type – 1st-generation progestin: norethindrone – Second-generation progestin = levonorgestrel – Third-generation progestin = 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)
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
least one detachment in one cycle
Creinin Obstet Gynecol 2008
EE Exposure with combined hormonal contraception
AUC (pg/ml): Patch = 37.7 + 5.6 COC = 22.7 + 2.8 Ring = 11.2 + 2.7
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Patch and VTE* 2 studies, 2 results
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 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
Scholes Arch Pediatr Adolesc Med, 2005. Scholes, Epidemiology, 2002. WHO 2005 ACOG 2008 Committee Opinion 415
Progestin Injection: Delay
• 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)
Levonorgestrel Intrauterine System (LNG-IUS)
• Levonorgestrel 20 mcg/day • Serum concentration 1/106
lower1
• 0.1% failure (1 yr) 1.1% (7 yr)
Lockhat Fertil Steril, 2005 Comparable to BTL failure rate of 1.8% /10 yrs
10 years
5 years
Worldwide Use of IUD
Population Reference Bureau, 2002.
Asia Europe Latin America & Caribbean
Africa Oceania North America
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Duration
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IUD & Vaginal Bleeding
Study Group Mean Blood Loss (mL) Control 35 Paragard 50-80 Mirena 5
– After 12 mos: average 90% decrease blood – Increased spotting common in first 3-6 months – 50% have amenorrhea by 1 year
Speroff & Darney Clinical Guide for Contraception 2005
Is Jane a candidate for an IUD?
• Contraindications to CHC or other methods
• No active cervicitis or PID – Screen women appropriately for GC/CT – Treat those with positive cultures
Women of any reproductive age seeking long-term, highly effective contraception
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LNG-IUS Copper T Duration 5 years 10 years Bleeding Lighter & irregular Same or heavier Non-contraceptive benefits
• Menorrhagia • Pelvic Pain • Endometrial hyperplasia
None
Hormone Min. systemic absorption
No hormone
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
evidence – Consider chart-based prompt
Contraception Methods
Episodic Daily Weekly Monthly 3 Mo’s 3 yrs 5 yrs 10 yrs Permanent
Barrier
OCPs
Patch
Ring
DMPA (IM or SQ)
Progestin Implant
LNG-IUS
Copper IUD
BTL Hysteroscopic
Vasectomy
Combined Hormonal Progestin Only IUC Sterilization
Least effective Most effective
EC
Resources
• WHO and US Medical Eligibility Criteria for Contraceptive Use – www.who.int – www.cdc.gov – www.reproductiveaccess.org
• A Pocket Guide to Managing Contraception 2010-12.
• UCSF Family Planning Consult Service – (415) 443-6318
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Acknowledgments
• Thanks to all who have shared slides – Carolyn Sufrin – Mike Policar
Appendix
• Evidence-based guidelines – Missed pill, patch, ring, injection – Society of Obstetricians and Gynaecologists
of Canada – www.sogc.org
• US MEC Tables
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