Conditions: Breast Feeding Contraception
Keywords: Breastfeeding rates Contraceptive continuation Birth control pills Lactation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 197
Healthy volunteers: yes

Brief 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.

Detailed description:

Arms:
arm 1: Study Arm A is one of two interventions (Combined estrogen-progestin pill) arm 2: Study Arm B is one of two interventions (Progestin-only pill)

Interventions: intervention 1: Combined estrogen-progestin pill intervention 2: Progestin-only pill
Intervention descriptions: intervention 1: 1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo intervention 2: .35 mg norethindrone once a day orally

Protocol document: