Breastfeeding and Oral Contraceptives: a Randomized, Controlled Trial

April 14, 2016 updated by: Eve Espey, University of New Mexico

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

197

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Continued to Breastfeed at 6 Months
Time Frame: 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
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
Time Frame: 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
Baseline to Week 8, Week 8, 2-6 months
Infant Length Growth From 2-8 Weeks
Time Frame: 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.
Week 2 and Week 8
Infant Weight Growth From 2-8 Weeks
Time Frame: 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.
Week 2 and Week 8
Infant Occipitofrontal Circumference Growth From 2-8 Weeks
Time Frame: 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.
Week 2 and Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of New Mexico

Collaborators

American College of Obstetricians and Gynecologists

Investigators

  • Principal Investigator: Eve Espey, MD, UNM OB Gyn

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

November 1, 2011

First Submitted That Met QC Criteria

November 1, 2011

First Posted (Estimate)

November 4, 2011

Study Record Updates

Last Update Posted (Estimate)

May 20, 2016

Last Update Submitted That Met QC Criteria

April 14, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-151

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Contraception

Clinical Trials on Combined estrogen-progestin pill

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Equatorial Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe