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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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