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

University of California San Diego

Status and phase

Completed

Phase 4

Conditions

Postpartum Contraception

DMPA

Lactation

Depot Medroxyprogesterone Acetate

Treatments

Drug: Depo Medroxyprogesterone acetate

Study type

Interventional

Funder types

Other

Identifiers

NCT06816901

811161

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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)