NCT01465022

Breastfeeding and Oral Contraceptives: a Randomized, Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 197 (actual)
• Sponsor: University of New Mexico · Academic / Other
• Sex: Female
• Age: 15 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Breast Feeding
• Contraception

Interventions

Type	Name	Description
DRUG	Combined estrogen-progestin pill	1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo
DRUG	Progestin-only pill	.35 mg norethindrone once a day orally

Timeline

• Start date: 2005-01-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2011-11-04
• Last updated: 2016-05-20
• Results posted: 2016-01-15