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OpenTrials
Completed

NCT Number: NCT01465022

Breastfeeding and Oral Contraceptives: a Randomized, Controlled Trial

Objectives

To clarify the relationship between postpartum (2 weeks) use of progestin-only vs. combined oral contraceptive pills and the outcomes of breastfeeding continuation, infant growth, contraceptive method continuation, and pregnancy rates in breastfeeding women. Specific research questions:

1. To determine whether there is a difference in rates of breastfeeding continuation at 2 months and 4 months between postpartum breastfeeding women using progestin-only pills vs. combined pills. 2. To determine whether there is a difference in infant growth at 2 weeks and 8 weeks between postpartum breastfeeding women using progestin-only pills vs. combined pills. 3. To determine whether there is a difference in birth control method continuation at 2 months and 4 months between postpartum breastfeeding women using progestin-only pills vs. combined pills.

Hypothesis

Combined oral contraceptive pills, when initiated by postpartum breastfeeding women, will cause a differential in continuation of breastfeeding: 35% continuation in the combined pill group vs. 60% in the progestin-only pill group at 8 weeks.

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Key information

Conditions

Breast Feeding Behavior Contraception Feeding Behavior

Age range

15 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • able to give informed consent
  • postpartum women delivering at the University of New Mexico Hospital
  • Intend to breastfeed
  • Plan to use oral contraceptives as her family planning method
  • Willing to be randomized to either progestin-only pills or combined pills

Exclusion criteria

  • medical contraindications to combined pills including history of thromboembolism, uncontrolled hypertension or complex migraine headaches
  • preterm birth (<37 weeks)
  • small for gestational age infant (<2500 grams)
  • large for gestational age infant (>4500 grams)
  • infant with major congenital anomaly

Treatment and study plan

Combined estrogen-progestin pill

Drug

1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo

Other names: OCP

Progestin-only pill

Drug

.35 mg norethindrone once a day orally

Other names: POP

Primary outcomes

  1. Number of Participants Who Continued to Breastfeed at 6 Months

    Time frame: Baseline to Week 8, Week 8, 2-6 months

    Proportion of participants who are continuing to breastfeed from 2 months to 6 months after delivery

Secondary outcomes

  1. Number of Participants Who Continued Birth Control Method After 6 Months

    Time frame: Baseline to Week 8, Week 8, 2-6 months

    Proportion of participants who are continuing to use either combined estrogen-progestin pill or progestin-only pill up to 6 months after delivery

  2. Infant Length Growth From 2-8 Weeks

    Time frame: Week 2 and Week 8

    Comparison of infant length at 2 weeks and 8 weeks between postpartum breastfeeding women using progestin-only pills vs. combined pills. Inclusion criteria of mother's who are actively breastfeeding.

  3. Infant Weight Growth From 2-8 Weeks

    Time frame: Week 2 and Week 8

    Comparison of infant growth at 2 weeks and 8 weeks between postpartum breastfeeding women using progestin-only pills vs. combined pills. Inclusion criteria of mother's who are actively breastfeeding.

  4. Infant Occipitofrontal Circumference Growth From 2-8 Weeks

    Time frame: Week 2 and Week 8

    Comparison of infant growth at 2 weeks and 8 weeks between postpartum breastfeeding women using progestin-only pills vs. combined pills. Inclusion criteria of mother's who are actively breastfeeding.

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Collaborators

  • American College of Obstetricians and Gynecologists

Registry information

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Nov 4, 2011
Registry last updated
May 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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