Breastfeeding and Oral Contraceptives: a Randomized, Controlled Trial

Not Applicable

Completed

• Conditions: Breast Feeding; Contraception
• Interventions: Drug: Combined estrogen-progestin pill; Drug: Progestin-only pill

• Registration Number: NCT01465022
• Lead Sponsor: University of New Mexico

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

Not available

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Study First Submitted: 2011-11-01
• Study First Submitted QC: 2011-11-01
• Study First Posted: 2011-11-04
• Results First Submitted: 2015-05-29
• Results First Submitted QC: 2015-12-02
• Results First Posted: 2016-01-15
• Status Verified: 2016-02
• Last Update Submitted: 2016-04-14
• Last Update Posted: 2016-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 197

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Arm A	Combined estrogen-progestin pill	Study Arm A is one of two interventions (Combined estrogen-progestin pill)
Study Arm B	Progestin-only pill	Study Arm B is one of two interventions (Progestin-only pill)

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Continued to Breastfeed at 6 Months	Baseline to Week 8, Week 8, 2-6 months	Proportion of participants who are continuing to breastfeed from 2 months to 6 months after delivery

Secondary Outcome Measures

Name	Time	Method
Infant Occipitofrontal Circumference Growth From 2-8 Weeks	Week 2 and Week 8	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.
Number of Participants Who Continued Birth Control Method After 6 Months	Baseline to Week 8, Week 8, 2-6 months	Proportion of participants who are continuing to use either combined estrogen-progestin pill or progestin-only pill up to 6 months after delivery
Infant Length Growth From 2-8 Weeks	Week 2 and Week 8	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.
Infant Weight Growth From 2-8 Weeks	Week 2 and Week 8	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.