Birth control and breastfeeding

What does the evidence say?

Eve Espey, MD MPH

Mark Twain

Get your facts straight,Then you can distort ‘em any way

you want

Objectives

Understand the current evidence related to the impact of hormonal contraception on breastfeeding Describe current expert opinion about the appropriate choice of hormonal contraceptives for breastfeeding womenBe aware of future directions for research in this area

Case

18 y/o G1P1 s/p NSVD yesterday is ready for discharge. You note on the chart that she is breastfeeding. You have counseled her about birth control pills.

What should you prescribe?

Answer

An IUD

Birth control and breastfeeding

Public health issue of global importance100 million postpartum women/yr decide:– What method– When to start it

Oral contraceptive use worldwide

1980 53.4 million1988 62.9 million2000 84.0 million

2 Good Things

Postpartum contraception– Birth interval < 24

months rarely desired

– Maternal/infant mortality

Breastfeeding– Complete nutrition– Safe food source– Immunological

defense– Saves money– Reduces risk of

breast and ovarian cancer

Global strategy on infant and young child nutrition

Revitalization of the global commitment to appropriate infant and young child

nutrition, and in particular to breastfeeding

WHO, 4/02

US commitment to breastfeeding

American Academy of Pediatrics– Breastfeeding is the ideal method of

feeding and nurturing infants

Healthy People 2010– Increase rates of breastfeeding initiation

and continuation

Breastfeeding statistics

Initiation 6 months 1 year

2010 goal 75% 50% 25%

US 64% 29% 16%

NM 78% ?? ??

Factors affecting breastfeeding

Favorable factors– Older age– Higher income– More education

Unfavorable factors– Teens– Lower income– Less education– Smoking

Family planning in NM

44% pregnancies unintended in 2000Half to couples using no methodHalf used a method inconsistently, incorrectly or a method with a high failure rate

PRAMS, 2001

Lactation: During pregnancy

Placenta

Estrogen

Progesterone

GnRH

FSH/LH

PIF PROLACTIN

NO MILK

Lactation: After birth

Delivery of placenta

Estrogen

Progesterone

Infant suckling

PI F PROLACTIN

MILK

Oxytocin

Potential harms of hormonal contraception

Quality of milkPassage of hormones to the infantInfant growth, milk quantity, duration of breastfeeding

Potential harms of hormonal contraception

Quality of milk

Passage of hormones to the infantInfant growth, milk quantity

Quality of milk

WHO, 1988“10 cc aliquots expressed, freeze-dried and transported to London by air” Some differences in micro-nutrients and fat content– Conflicting interpretation of significance– Infant growth a better, but elusive outcome

Potential harms of hormonal contraception

Quality of milkPassage of hormones to the infant

Infant growth, milk quantity, duration of breastfeeding

Passage of hormones to infant

Case reportsMeasuring steroid content of breast milkEstradiol in breast milk AND in maternal serum after ingestion of pill (50mic)600 cc breastmilk/day from mother taking a 50 mic COC:– 10 ng of estradiol compared with– 3-6 ng during anovulatory cycles– 6-12 ng during ovulatory cycles

Long term effects: Nilsson, 1986

48 children exposed to COCs in breastmilk48 controls8 year follow-upNo differences in– Growth – Disease– Intellectual development– Psychological behavior

Potential harms of hormonal contraception

Quality of milkPassage of hormones to the infantInfant growth, milk quantity, duration of breastfeeding

Combined pills: 3 RCTs

2: COC vs. placebo1: COC vs. progestin-only

Problems with RCTs

Methods of randomization unclearMethods for allocation concealment unclearSmall sample sizesLarge loss-to-follow-up ratesMethods for measuring milk output may not reflect breastmilk production

Semm, 1966

N = 100 womenMunich, Germany 50 – high dose COC on PP days #1-1050 – identically packaged placebosOutcomes– No differences in milk volume, lactation initiation or

infant growth during the first 10 postpartum days

Miller, 1970

N= 50 women – Iowa25 – high dose COC begun at 2 wks x 21 days25 – identically packaged placebosOutcome– Less milk volume as measured by supplemental

feeds and duration of breastfeeding– Prior successful BFing best determinant of BFing to

3 mos

WHO, 1984, 1986, 1988

Hungary, ThailandN = 171 women choosing oral contraceptives– Age 25-35– Multips (2-4 live births)– Prior successful breastfeeding– Infants 2700 – 3700 gms

86 – low-dose COC begun 6 wks PP85 – progestin-only begun 6 wks PP

WHO outcomes

Breast milk volume @ 4 wk intervals x 6 mosBreast milk compositionInfant growth– 6, 9, 12, 16, 20 and 24 weeks

WHO results

Milk volume decreased in both groups from wk 6-24– 41% COC– 12% progestin-only

No differences in – Supplementation– “inadequate milk production”– breastfeeding continuation– infant growth– milk composition

WHO disclaimer

“… our method of measuring milk output… may have little relationship to the amount actually ingested by the baby during that or any other 24-hour period.”

WHO conclusions

“Combined oral contraceptives cannot be recommended for use during early lactation. The age at which it seems safe to recommend them will be a subject for debate and controversy.”

2 RCTs: Progestin-only pills

1: Progestin-only vs. placebo1: Progestin-only vs. progestin-only, timing of start

Velasquez, 1976

N = 20 womenMexico 12 – NET (progestin only) on PP days #1-14 8 – identically packaged placebosOutcomes– No differences in milk volume, infant growth or milk

composition during 14 days of the study

Were, 1997

N = 200 womenEldoret, Kenya 100 – progestin-only begun 6 weeks PP100 – progestin-only begun 6 months PPOutcomes– No effect on contraceptive continuation rates– No effect on pregnancy rates

DMPA: no RCTs

WHO non-randomized trial, 1994:– 2466 mother-infant pairs

• POP• DMPA• Norplant• Non-hormonal

Results:– No differences in infant growth

Progestin-only

Halderman, 2002Compare breastfeeding continuation in women given DMPA before discharge, POPs, vs. non-hormonal methods 319 women– 102 DMPA– 77 POPs– 138 Non-hormonal (barriers, abstinence)

DMPA received at mean 52 hours after delivery (range: 3 hrs to 132 hrs)

Halderman, 2002

2 weeks: No difference in BF continuation or supplementation– 60% supplementing across all groups– 56% cited insufficient milk

4 weeks: 77% DMPA BF vs. 83% non-horm BF (p=.02)– No differences in insufficient milk

6 weeks: No differences in BF continuation

ACOG Recommendations for Hormonal Contraception “if used”

POPs to start 2-3 weeks postpartumDMPA to start at 6 weeks postpartumCOCs, if prescribed, should not be started before 6 weeks postpartum, and only when lactation is well established and the infant's nutritional status well-monitored

ACOG bulletin: Breastfeeding: Maternal and infant aspects 7/00

ACOG Practice bulletin 2000

“Progestin-only preparations are safe and preferable forms of hormonal contraception for lactating women. Combination OCs are not recommended as the first choice for breastfeeding mothers because of the negative impact of contraceptive doses of estrogen on lactation.” Level A evidence

The use of hormonal contraception in women with

coexisting medical conditions, ACOG, 7/00

Levels of evidence

Level A: Recommendations are based on good and consistent scientific evidenceLevel B: … based on limited or inconsistent scientific evidenceLevel C: …based on consensus and expert opinion

Cochrane Review 2003

Evidence from RCTs is limited and of poor qualityNo established link between hormonal contraception and milk quality/quantityEvidence inadequate to make recommendations regarding hormonal contraceptive use for breastfeeding women

Hormonal contraception & lactation

What do providers prescribe?

Single study – Rochat 1981– Survey: 3697 doctors in 72 countries– 831 responses - 22% response rate– 45% ever prescribed COCs for BF women

– Woman’s preference– Previous BF history– International Planned Parenthood guidelines

Survey of New Mexico OB-GYNs and CNMs

Questions– Prescribing practices– Attitudes about OCs for BFing women– Knowledge questions

What do the residents prescribe?

10/10 RX hormonal contraceptives10 start DMPA prior to hospital discharge8 start COCs at 2 weeks PP2 start COCs at 6 weeks PPNone discourage COCs in BF women3: Recommend if factors favorable (2-6 wks)6: Recommend routinely as benefits outweigh risks

(2-6 wks)

RCT: Choice of OC for BF postpartum women

Women to be randomized to POPs vs. COCsDouble-blind RCT (pills packaged identically) Begin at 2 weeks PP– Outcome measures:

• Breastfeeding continuation at 2 months PP• Infant weight • Method continuation

Successful breastfeeding