Breastfeeding and Oral Contraceptives: a Randomized, Controlled Trial

This study has been completed.
Sponsor:
Collaborator:
American College of Obstetricians and Gynecologists
Information provided by (Responsible Party):
Eve Espey, University of New Mexico
ClinicalTrials.gov Identifier:
NCT01465022
First received: November 1, 2011
Last updated: April 14, 2016
Last verified: February 2016
  Purpose

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.


Condition Intervention
Breast Feeding
Contraception
Drug: Combined estrogen-progestin pill
Drug: Progestin-only pill

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Breastfeeding and Oral Contraceptives: a Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • Number of Participants Who Continued to Breastfeed at 6 Months [ Time Frame: Baseline to Week 8, Week 8, 2-6 months ] [ Designated as safety issue: No ]
    Proportion of participants who are continuing to breastfeed from 2 months to 6 months after delivery


Secondary Outcome Measures:
  • Number of Participants Who Continued Birth Control Method After 6 Months [ Time Frame: Baseline to Week 8, Week 8, 2-6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 2 and Week 8 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 2 and Week 8 ] [ Designated as safety issue: No ]
    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.

  • Infant Occipitofrontal Circumference Growth From 2-8 Weeks [ Time Frame: Week 2 and Week 8 ] [ Designated as safety issue: No ]
    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.


Enrollment: 197
Study Start Date: January 2005
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: POP

  Eligibility

Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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 (<37 weeks)
  • small for gestational age infant (<2500 grams)
  • large for gestational age infant (>4500 grams)
  • infant with major congenital anomaly
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01465022

Sponsors and Collaborators
University of New Mexico
American College of Obstetricians and Gynecologists
Investigators
Principal Investigator: Eve Espey, MD UNM OB Gyn
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eve Espey, Professor, OB-GYN, University of New Mexico
ClinicalTrials.gov Identifier: NCT01465022     History of Changes
Other Study ID Numbers: 03-151 
Study First Received: November 1, 2011
Results First Received: May 29, 2015
Last Updated: April 14, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of New Mexico:
Breastfeeding rates
Contraceptive continuation
Birth control pills
Lactation

Additional relevant MeSH terms:
Progestins
Contraceptive Agents
Estrogens
Contraceptives, Oral
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on July 27, 2016