Official Title
Breastfeeding and Oral Contraceptives: a Randomized, Controlled Trial
Phase
N/ALead Sponsor
University of New MexicoStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Breast Feeding ContraceptionStudy Participants
197Objectives
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:
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.
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.
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.
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
Study Arm A is one of two interventions (Combined estrogen-progestin pill)
Study Arm B is one of two interventions (Progestin-only pill)
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
| Event Type | Organ System | Event Term |
|---|
Proportion of participants who are continuing to breastfeed from 2 months to 6 months after delivery
Proportion of participants who are continuing to use either combined estrogen-progestin pill or progestin-only pill up to 6 months after delivery
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.
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.
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.
