Breastfeeding and Oral Contraceptives: a Randomized, Controlled Trial

Study Overview
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Brief Summary
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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: 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. 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. 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.

Official Title
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Breastfeeding and Oral Contraceptives: a Randomized, Controlled Trial

Conditions
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Breast Feeding, Contraception

Intervention / Treatment
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* Drug: Combined estrogen-progestin pill
* Drug: Progestin-only pill


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study Arm A<br>Study Arm A is one of two interventions (Combined estrogen-progestin pill) | Drug: Combined estrogen-progestin pill<br>* 1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo<br>* Other names: OCP;|
| Active Comparator: Study Arm B<br>Study Arm B is one of two interventions (Progestin-only pill) | Drug: Progestin-only pill<br>* .35 mg norethindrone once a day orally<br>* Other names: POP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Continued to Breastfeed at 6 Months | Proportion of participants who are continuing to breastfeed from 2 months to 6 months after delivery | Baseline to Week 8, Week 8, 2-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Continued Birth Control Method After 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 | Baseline to Week 8, Week 8, 2-6 months | 
| Infant Length Growth From 2-8 Weeks | 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. | Week 2 and Week 8 | 
| Infant Weight Growth From 2-8 Weeks | 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. | Week 2 and Week 8 | 
| Infant Occipitofrontal Circumference Growth From 2-8 Weeks | 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. | Week 2 and Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breastfeeding rates, Contraceptive continuation, Birth control pills, Lactation