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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
197
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
Number of Participants Who Continued to Breastfeed at 6 Months
Proportion of participants who are continuing to breastfeed from 2 months to 6 months after delivery
Time frame: Baseline to Week 8, Week 8, 2-6 months
Number of Participants Who Continued Birth Control Method After 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
Time frame: Baseline to Week 8, Week 8, 2-6 months
Infant Length Growth From 2-8 Weeks
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.
Time frame: Week 2 and Week 8
Infant Weight Growth From 2-8 Weeks
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.
Time frame: Week 2 and Week 8
Infant Occipitofrontal Circumference Growth From 2-8 Weeks
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.
Time frame: Week 2 and Week 8
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