Clinical Trials Directory

Trials / Completed

CompletedNCT06816901

Measuring Lactation Initiation After Early Postpartum Injectable Progestin (DMPA) Use Among Women in Dhanusha District of Nepal: A Pilot Study

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

Summary

This is a pilot study of early postpartum initiation of the injectable progestin contraception, depo medroxyprogesterone acetate (DMPA), among 40 postpartum people. The study aims to assess the feasibility to conduct a larger trial evaluating the effects of early postpartum initiation DMPA on lactation and infant growth outcomes in Nepal.

Detailed description

The primary objective of this study is to pilot the procedures necessary to demonstrate feasibility for a larger randomized trial evaluating the effects of early postpartum initiation of DMPA on time to lactogenesis (transition to mature milk), lactation continuation, and infant growth and development. The investigators will conduct a pilot study among 40 birthing people who deliver a singleton, healthy, term infant; intend to feed their infant human milk (breastfeed) exclusively for at least 6 months; and plan to use DMPA for postpartum contraception. Participants will be administered DMPA within 48 hours after birth and will be followed for 12 weeks postpartum. Time to lactogenesis, the proportion of participants exclusive feed their infant human milk at 12 weeks, any lactation and infant growth through 12 weeks will be measured. We will analyze time to onset of lactogenesis the proportion of participants exclusively feeding human milk at 12 weeks.

Conditions

Interventions

TypeNameDescription
DRUGDepo Medroxyprogesterone acetateInitiation of injectable depo medroxyprogesterone acetate (DMPA) contraception within 48 hours after birth

Timeline

Start date
2025-03-26
Primary completion
2025-07-31
Completion
2025-07-31
First posted
2025-02-10
Last updated
2025-09-10

Locations

1 site across 1 country: Nepal

Source: ClinicalTrials.gov record NCT06816901. Inclusion in this directory is not an endorsement.