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

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.

Study Overview

• Status: Completed
• Conditions: Lactation; Postpartum Contraception; DMPA; Depot Medroxyprogesterone Acetate
• Intervention / Treatment: Drug: Depo Medroxyprogesterone acetate

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Nepal
  • Dhanusha District
    • Janakpur Dham, Dhanusha District, Nepal
      • Provincial Hospital Janakpur of Dhanusha district

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Initiation of injectable depo medroxyprogesterone acetate (DMPA) within 48 hours of birth	Drug: Depo Medroxyprogesterone acetate; Initiation of injectable depo medroxyprogesterone acetate (DMPA) contraception within 48 hours after birth; Other Names: DMPA; Injectable contraception

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to lactogensis	Amount of time (in hours) from birth to lactogenesis	148 hours
Exclusive lactation	Proportion of participants who report exclusive lactation without supplementation	12 weeks
DMPA Continuation	The proportion of participants who use DMPA continuously for 12 weeks and return for a second dose	12 weeks
Change in infant weight	Infant weight in grams will be compared over 4 weeks	Birth to 4 weeks
Change in infant length	Infant length in millimeters will be compared over 4 weeks	Birth to 4 weeks
Change in infant head circumference	The maximum diameter through the infant's glabella and occiput is found and measured with a tape measure and recorded to the nearest millimeter and compared over 4 weeks	Birth to 4 weeks

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: Center for Research on Environment, Health and Population Activities
• Investigators: Principal Investigator: Sarah Averbach, MD, MAS, University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2025
• Primary Completion (Actual): July 31, 2025
• Study Completion (Actual): July 31, 2025

Study Registration Dates

• First Submitted: February 4, 2025
• First Submitted That Met QC Criteria: February 4, 2025
• First Posted (Actual): February 10, 2025

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: September 3, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: contraception; postpartum; family planning; DMPA; Depo; Injectable contaception
• Additional Relevant MeSH Terms: Behavior; Feeding Behavior; Breast Feeding; Polycyclic Compounds; Pregnanes; Steroids; Fused-Ring Compounds; Pregnenediones; Pregnenes; Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Medroxyprogesterone Acetate; N,N-dimethyl-4-anisidine
• Other Study ID Numbers: 811161

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No