Birth control and breastfeeding What does the evidence say?

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Birth control and breastfeeding What does the
evidence say?

• Eve Espey, MD MPH

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Mark Twain

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

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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 women
• Be aware of future directions for research in
  this area

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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?

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Answer

• An IUD

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Birth control and breastfeeding

• Public health issue of global importance
• 100 million postpartum women/yr decide
• What method
• When to start it

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Oral contraceptive use worldwide

• 1980 53.4 million
• 1988 62.9 million
• 2000 84.0 million

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2 Good Things

• Postpartum contraception
• Birth interval lt 24 months rarely desired
• Maternal/infant mortality

• Breastfeeding
• Complete nutrition
• Safe food source
• Immunological defense
• Saves money
• Reduces risk of breast and ovarian cancer

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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

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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

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Breastfeeding statistics
Initiation 6 months 1 year
2010 goal 75 50 25
US 64 29 16
NM 78 ?? ??
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Factors affecting breastfeeding

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

• Favorable factors
• Older age
• Higher income
• More education

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Family planning in NM

• 44 pregnancies unintended in 2000
• Half to couples using no method
• Half used a method inconsistently, incorrectly or
  a method with a high failure rate
• PRAMS, 2001

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Lactation During pregnancy
Placenta
Estrogen Progesterone
GnRH FSH/LH
PIF

NO MILK
PROLACTIN
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Lactation After birth
Delivery of placenta
Estrogen Progesterone
Infant suckling
PI F

MILK
PROLACTIN
Oxytocin
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Potential harms of hormonal contraception

• Quality of milk
• Passage of hormones to the infant
• Infant growth, milk quantity, duration of
  breastfeeding

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Potential harms of hormonal contraception

• Quality of milk
• Passage of hormones to the infant
• Infant growth, milk quantity

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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

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Potential harms of hormonal contraception

• Quality of milk
• Passage of hormones to the infant
• Infant growth, milk quantity, duration of
  breastfeeding

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Passage of hormones to infant

• Case reports
• Measuring steroid content of breast milk
• Estradiol 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

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Long term effects Nilsson, 1986

• 48 children exposed to COCs in breastmilk
• 48 controls
• 8 year follow-up
• No differences in
• Growth
• Disease
• Intellectual development
• Psychological behavior

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Potential harms of hormonal contraception

• Quality of milk
• Passage of hormones to the infant
• Infant growth, milk quantity, duration of
  breastfeeding

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Combined pills 3 RCTs

• 2 COC vs. placebo
• 1 COC vs. progestin-only

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Problems with RCTs

• Methods of randomization unclear
• Methods for allocation concealment unclear
• Small sample sizes
• Large loss-to-follow-up rates
• Methods for measuring milk output may not reflect
  breastmilk production

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Semm, 1966

• N 100 women
• Munich, Germany
• 50 high dose COC on PP days 1-10
• 50 identically packaged placebos
• Outcomes
• No differences in milk volume, lactation
  initiation or infant growth during the first 10
  postpartum days

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Miller, 1970

• N 50 women Iowa
• 25 high dose COC begun at 2 wks x 21 days
• 25 identically packaged placebos
• Outcome
• Less milk volume as measured by supplemental
  feeds and duration of breastfeeding
• Prior successful BFing best determinant of BFing
  to 3 mos

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WHO, 1984, 1986, 1988

• Hungary, Thailand
• N 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 PP
• 85 progestin-only begun 6 wks PP

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WHO outcomes

• Breast milk volume _at_ 4 wk intervals x 6 mos
• Breast milk composition
• Infant growth
• 6, 9, 12, 16, 20 and 24 weeks

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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

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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.

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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.

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2 RCTs Progestin-only pills

• 1 Progestin-only vs. placebo
• 1 Progestin-only vs. progestin-only, timing of
  start

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Velasquez, 1976

• N 20 women
• Mexico
• 12 NET (progestin only) on PP days 1-14
• 8 identically packaged placebos
• Outcomes
• No differences in milk volume, infant growth or
  milk composition during 14 days of the study

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Were, 1997

• N 200 women
• Eldoret, Kenya
• 100 progestin-only begun 6 weeks PP
• 100 progestin-only begun 6 months PP
• Outcomes
• No effect on contraceptive continuation rates
• No effect on pregnancy rates

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DMPA no RCTs

• WHO non-randomized trial, 1994
• 2466 mother-infant pairs
• POP
• DMPA
• Norplant
• Non-hormonal
• Results
• No differences in infant growth

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Progestin-only

• Halderman, 2002
• Compare 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)

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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

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ACOG Recommendations for Hormonal Contraception
if used

• POPs to start 2-3 weeks postpartum
• DMPA to start at 6 weeks postpartum
• COCs, 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

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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
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Levels of evidence

• Level A Recommendations are based on good and
  consistent scientific evidence
• Level B based on limited or inconsistent
  scientific evidence
• Level C based on consensus and expert opinion

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Cochrane Review 2003

• Evidence from RCTs is limited and of poor quality
• No established link between hormonal
  contraception and milk quality/quantity
• Evidence inadequate to make recommendations
  regarding hormonal contraceptive use for
  breastfeeding women
• Hormonal contraception lactation

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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
• Womans preference
• Previous BF history
• International Planned Parenthood guidelines

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Survey of New Mexico OB-GYNs and CNMs

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

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What do the residents prescribe?

• 10/10 RX hormonal contraceptives
• 10 start DMPA prior to hospital discharge
• 8 start COCs at 2 weeks PP
• 2 start COCs at 6 weeks PP
• None discourage COCs in BF women
• 3 Recommend if factors favorable (2-6 wks)
• 6 Recommend routinely as benefits outweigh
  risks
• (2-6 wks)

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RCT Choice of OC for BF postpartum women

• Women to be randomized to POPs vs. COCs
• Double-blind RCT (pills packaged identically)
• Begin at 2 weeks PP
• Outcome measures
• Breastfeeding continuation at 2 months PP
• Infant weight
• Method continuation

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Successful breastfeeding