At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Breastfeeding and Oral Contraceptives: a Randomized, Controlled Trial
In Brief
A clinical study evaluating Combined estrogen-progestin pill and Progestin-only pill for Breast Feeding and Contraception. Completed, enrolled 197 participants.
Detailed 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.
Study Details
Timeline
Interventions
1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo
.35 mg norethindrone once a day orally