Summary

Eligibility
for females ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at La Jolla, California
Dates
study started
estimated completion
Principal Investigator
by Sarah Averbach, MD, MAS
Photo of Sarah Averbach
Sarah Averbach

Description

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.

Details

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.

Keywords

Contraception Breastfeeding Minipill Progestin-only Pill Postpartum Slynd Camila Micronor Infant growth Breastmilk Drospirenone Norethindrone Contraceptive Agents Progestins Progestin Only Contraceptive Pills Early Initiation d-POPs Early Initiation n-POPs Interval Initiation of d-POPs

Eligibility

You can join if…

Open to females ages 18 years and up

  • 13 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

You CAN'T join if...

  • 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

Location

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

Lead Scientist at UCSD

  • Sarah Averbach, MD, MAS
    Associate Adjunct Professor, Ob/Gyn & Reproductive sciences. Authored (or co-authored) 41 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT04965116
Phase
Phase 4
Study Type
Interventional
Last Updated