Breastfeeding and Oral Contraceptives: a Randomized, Controlled Trial

Contraception Clinical Trial

Official title:

Breastfeeding and Oral Contraceptives: a Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01465022
• Other study ID #: 03-151
• Status: Completed
• Phase: N/A
• First received: November 1, 2011
• Last updated: December 2, 2015
• Start date: January 2005
• Est. completion date: June 2008

Study information

• Verified date: December 2015
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 months and 4 months 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.

4. To determine whether there are differences in pregnancy rates between the two groups over the time course of the study.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Feeding
• Contraception

Intervention

Drug:
• Combined estrogen-progestin pill
1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo
• Progestin-only pill
.35 mg norethindrone once a day orally

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of New Mexico	American College of Obstetricians and Gynecologists

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Continued to Breastfeed at 8 Weeks	Proportion of participants who are continuing to breastfeed at 8 weeks after delivery	8 weeks	No