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

NCT06816901 | Completed Phase 4

• 1 other identifier: 811161
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postpartum Contraception; Depot Medroxyprogesterone Acetate; Lactation; DMPA

Keywords

Depo; Injectable contaception; postpartum; contraception; family planning; DMPA

Outcome Measures

Primary Outcomes (1)

• Enrollment feasibility

  The ability of project staff to consent and enroll 40 individuals who are willing to participate in this pilot study within 12 weeks.

  12 weeks

Secondary Outcomes (6)

• Time to lactogensis

  148 hours

• Exclusive lactation

  12 weeks

• DMPA Continuation

  12 weeks

• Change in infant weight

  Birth to 4 weeks

• Change in infant length

  Birth to 4 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

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

Drug: Depo Medroxyprogesterone acetate

Interventions

Depo Medroxyprogesterone acetate DRUG

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

Also known as: DMPA, Injectable contraception

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Diego: lead
• Center for Research on Environment, Health and Population Activities: collaborator

Study Sites (1)

Provincial Hospital Janakpur of Dhanusha district

Janakpur Dham, Dhanusha District, Nepal

Location

MeSH Terms

Conditions

Breast Feeding

Interventions

Medroxyprogesterone Acetate; N,N-dimethyl-4-anisidine

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Sarah Averbach, MD, MAS

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 10, 2025
• Study Start: March 26, 2025
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)