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

NCT ID: NCT06816901

Last Updated: 2025-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-26

Study Completion Date

2025-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Postpartum Contraception Depot Medroxyprogesterone Acetate Lactation DMPA

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

Initiation of injectable depo medroxyprogesterone acetate (DMPA) within 48 hours of birth

Group Type EXPERIMENTAL

Depo Medroxyprogesterone acetate

Intervention Type DRUG

Initiation of injectable depo medroxyprogesterone acetate (DMPA) contraception within 48 hours after birth

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Depo Medroxyprogesterone acetate

Initiation of injectable depo medroxyprogesterone acetate (DMPA) contraception within 48 hours after birth

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

DMPA Injectable contraception

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Currently live in Nepal
* Had a vaginal or cesarean delivery of a singleton full-term infant within the past 48 hours
* Not yet undergone lactogenesis
* Desire to use DMPA as a method of postpartum contraception

Exclusion Criteria

* Desire a repeat pregnancy in less than 6 months
* Do not intend to exclusively feed infant own human milk for 6 months
* Do not have access to a telephone
* Any medical contraindication to DMPA
* Any contraindication to human milk feeding for their infant
* History of breast surgery (augmentation or reduction)
* Infant with a major congenital anomaly (will be excluded due to unique challenges with feeding in these populations)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Center for Research on Environment, Health and Population Activities

OTHER

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sarah Averbach, MD MAS

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sarah Averbach, MD, MAS

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Provincial Hospital Janakpur of Dhanusha district

Janakpur Dham, Dhanusha District, Nepal

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Nepal

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

811161

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Breastfeeding Etonogestrel Implant Study
NCT03978598 COMPLETED PHASE4
Breastfeeding - a Good Start Together
NCT05311631 ACTIVE_NOT_RECRUITING NA