Breastfeeding and Oral Contraceptives: a Randomized, Controlled Trial

University of New Mexico (UNM)

Status: Completed

Conditions: Breast Feeding; Contraception

Treatments: Drug: Progestin-only pill; Drug: Combined estrogen-progestin pill

Study type: Interventional

Funder types: Other

Identifiers

NCT01465022

03-151

Details and patient eligibility

About

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.

Enrollment: 197 patients

Sex: Female

Ages: 15 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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197 participants in 2 patient groups

Study Arm A

Active Comparator group

Description:

Study Arm A is one of two interventions (Combined estrogen-progestin pill)

Treatment:

Drug: Combined estrogen-progestin pill

Study Arm B

Active Comparator group

Description:

Study Arm B is one of two interventions (Progestin-only pill)

Treatment:

Drug: Progestin-only pill