Progestin-Only Pill Use and Breastfeeding Study

April 18, 2024 updated by: Sarah Averbach, MD MAS, University of California, San Diego
This study will assess the impact of early initiation (less than one week postpartum) and delayed initiation (4 weeks postpartum) of two types of progestin-only contraceptive pills (POPs) on maternal, breastmilk, and infant outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a placebo-controlled randomized controlled trial enrolling dyads of birthing people and their newborn infants. We will explore if the type and timing of initiation of pills is acceptable to the user with minimal side effects, impacts the supply or composition of breastmilk, and/or affects infant growth.

Birthing people will be randomly assigned to 1 of 3 groups and will be blinded to group assignment:

  1. immediate initiation of drospirenone-containing progestin-only pills (d-POPs),
  2. immediate initiation of norethindrone-containing progestin-only pills (n-POPs)
  3. immediate initiation of a placebo pill for one month followed by d-POPs.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093
        • University of California, San Diego

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18 years of age and older
  • Desires to use POPs for 3 months
  • Speak English or Spanish
  • Had a vaginal or cesarean delivery of a singleton full term (≥37 weeks) infant less than 168 hours prior
  • Intends to breastfeed exclusively for 6 months

Exclusion Criteria:

  • Desire another pregnancy in less than 6 months
  • Do not intend to exclusively breastfeed
  • Do not have access to a telephone
  • Have any medical contraindication to POPs
  • Have any contraindication to breastfeeding, including maternal illegal drug use, history of augmentation or reduction, infant with major congenital anomaly
  • Cognitively impaired
  • Currently incarcerated

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early Initiation d-POPs
Initiation of d-POPs 120-160 hours after delivery. Dosing is 4mg daily for 24 days followed by 4 daily inactive tablets for 2 months.
Drug: Progestin Only Contraceptive Pills
Daily pill (placebo or active tablet)
Other Names:
  • Micronor
  • Slynd
  • Camila
  • Errin
Experimental: Early Initiation n-POPs
Initiation of n-POPs 120-160 hours after delivery. Dosing is 0.35mg daily for 28 days for 2 months.
Drug: Progestin Only Contraceptive Pills
Daily pill (placebo or active tablet)
Other Names:
  • Micronor
  • Slynd
  • Camila
  • Errin
Placebo Comparator: Interval Initiation of d-POPs
Placebo starting 120-160 hours after delivery, continuing for 28 days. Followed by 24 days of 4mg daily of d-POPs and 4 daily inactive tablets.
Drug: Progestin Only Contraceptive Pills
Daily pill (placebo or active tablet)
Other Names:
  • Micronor
  • Slynd
  • Camila
  • Errin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exclusive Lactation Among Birthing People at 8 Weeks Postpartum.
Time Frame: 8 weeks postpartum
Lactation status will be assessed at 8 weeks postpartum through an email self-reported survey.
8 weeks postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Birthing People Using Progestin-only Pills at 8 Weeks Postpartum
Time Frame: 8 weeks postpartum
Type of contraception being used at 8 weeks postpartum will be assessed through an email self-reported survey.
8 weeks postpartum
Vaginal Bleeding
Time Frame: 8 weeks postpartum
Number of days of any bleeding and spotting among birthing people in last week will be collected via self-reported email survey.
8 weeks postpartum
Satisfaction With Assigned POP
Time Frame: 8 weeks postpartum
Overall satisfaction and if birthing people would recommend the POP they were assigned to use to a friend will be ascertained from an email self-report survey. Counts are the number of birthing people who responded "yes".
8 weeks postpartum
Protein Content of Human Milk
Time Frame: 4 weeks postpartum
Mid-feeding milk samples will be pumped by birthing people and analyzed.
4 weeks postpartum
Carbohydrate Content of Human Milk
Time Frame: 4 weeks postpartum
Mid-feeding milk samples will be pumped by birthing people and analyzed.
4 weeks postpartum
Fat Content of Human Milk
Time Frame: 4 weeks postpartum
Mid-feeding milk samples will be pumped by birthing people and analyzed.
4 weeks postpartum
Perception of Milk Supply
Time Frame: 8 weeks postpartum
Self-reported perception of adequacy of milk supply will be collected with the 20-item Hill and Humenick Lactation Scale among birthing people. Minimum scale score is 20 and maximum is 140, with higher scores representing a more positive perception of breastfeeding.
8 weeks postpartum
Change in Infant Weight
Time Frame: Baseline and 4 weeks after delivery
Infant weight in grams will be compared over 4 weeks.
Baseline and 4 weeks after delivery
Change in Infant Height
Time Frame: Baseline and 4 weeks after delivery
Infant length as measured on a marked board to the nearest millimeter will be compared over 4 weeks.
Baseline and 4 weeks after delivery
Change in Infant Head Circumference
Time Frame: Baseline and 4 weeks after delivery
The maximum diameter through the infant's glabella and occiput is found and measured with a tape measure and recorded to the nearest millimeter and compared over 4 weeks.
Baseline and 4 weeks after delivery

Collaborators and Investigators

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

Sponsor

University of California, San Diego

Investigators

  • Principal Investigator: Sarah Averbach, MD, MAS, University of California, San Diego

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 (Actual)

October 25, 2021

Primary Completion (Actual)

November 4, 2022

Study Completion (Actual)

November 4, 2022

Study Registration Dates

First Submitted

June 26, 2021

First Submitted That Met QC Criteria

July 6, 2021

First Posted (Actual)

July 16, 2021

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 210357

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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.

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