Breastfeeding and Oral Contraceptives: a Randomized, Controlled Trial

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of New Mexico
• Collaborator: American College of Obstetricians and Gynecologists
• Treatments: Contraceptive Agents; Contraceptives, Oral; Estrogens; Progestins

Criteria

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