N/A N=197 Randomized Quadruple-blind Treatment

Breastfeeding and Oral Contraceptives: a Randomized, Controlled Trial

Breast Feeding · Contraception

Bottom Line

View on ClinicalTrials.gov: NCT01465022 ↗

Enrolled (actual)

197

Serious AEs

0.0%

Results posted

Jan 2016

Primary outcome: Primary: Number of Participants Who Continued to Breastfeed at 6 Months — 15; 14; 8; 9 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Combined estrogen-progestin pill (Drug); Progestin-only pill (Drug)
Age: Pediatric, Adult · 15+ yrs
Sex: Female
Sponsor: University of New Mexico
Primary completion: Jun 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Who Continued to Breastfeed at 6 Months	15; 14; 8; 9; 41; 40	—
SECONDARY Number of Participants Who Continued Birth Control Method After 6 Months	15; 14; 1; 0; 40; 40	—
SECONDARY Infant Length Growth From 2-8 Weeks	51.5; 51.7; 56.8; 57	—
SECONDARY Infant Weight Growth From 2-8 Weeks	3.7; 3.7; 5.08; 5.2	—
SECONDARY Infant Occipitofrontal Circumference Growth From 2-8 Weeks	36; 36.1; 39; 39	—

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.

Eligibility 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 ( 4500 grams)
infant with major congenital anomaly

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01465022). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.