NCT04965116

Progestin-Only Pill Use and Breastfeeding Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• Contraception
• Breastfeeding

Interventions

Type	Name	Description
DRUG	Progestin Only Contraceptive Pills	Daily pill (placebo or active tablet)

Timeline

• Start date: 2021-10-25
• Primary completion: 2022-11-04
• Completion: 2022-11-04
• First posted: 2021-07-16
• Last updated: 2024-04-19
• Results posted: 2024-04-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study