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

Phase 4

Not yet recruiting

• Conditions: Postpartum Contraception; Depot Medroxyprogesterone Acetate; Lactation; DMPA
• Interventions: Drug: Depo Medroxyprogesterone acetate

• Registration Number: NCT06816901
• Lead Sponsor: University of California, San Diego

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.

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 Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-04
• Study First Submitted QC: 2025-02-04
• Last Update Submitted: 2025-02-07
• Study First Posted: 2025-02-10
• Last Update Posted: 2025-02-11
• Study Start: 2025-03
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Depo Medroxyprogesterone acetate	Initiation of injectable depo medroxyprogesterone acetate (DMPA) within 48 hours of birth

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time to lactogensis	148 hours	Amount of time (in hours) from birth to lactogenesis
Change in infant length	Birth to 4 weeks	Infant length in millimeters will be compared over 4 weeks
Change in infant head circumference	Birth to 4 weeks	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
Change in infant weight	Birth to 4 weeks	Infant weight in grams will be compared over 4 weeks
Exclusive lactation	12 weeks	Proportion of participants who report exclusive lactation without supplementation
DMPA Continuation	12 weeks	The proportion of participants who use DMPA continuously for 12 weeks and return for a second dose

Trial Locations

Locations (1)

Provincial Hospital Janakpur of Dhanusha district; 🇳🇵 Janakpur, Dhanusha district, Nepal