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Breastfeeding and Oral Contraceptives: a Randomized, Controlled Trial

NCT01465022 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 197

Last updated 2016-05-20

Study results available
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Summary

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.

Conditions

  • Breast Feeding
  • Contraception

Interventions

DRUG

Combined estrogen-progestin pill

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

DRUG

Progestin-only pill

.35 mg norethindrone once a day orally

Sponsors & Collaborators

  • American College of Obstetricians and Gynecologists

    collaborator OTHER

  • University of New Mexico

    lead OTHER

Principal Investigators

  • Eve Espey, MD · UNM OB Gyn

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2008-06-30
Completion
2008-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01465022 on ClinicalTrials.gov