Contraception Clinical Trial
Official title:
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 months and 4 months
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.
4. To determine whether there are differences in pregnancy rates between the two groups
over the time course of the study.
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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