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Clinical Trial 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.


Clinical Trial Description

This is a placebo-controlled randomized controlled trial enrolling dyads of mothers and their newborn babies. 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. Women 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 Design


Related Conditions & MeSH terms


NCT number NCT04965116
Study type Interventional
Source University of California, San Diego
Contact
Status Completed
Phase Phase 4
Start date October 25, 2021
Completion date October 21, 2022

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