Clinical trial NCT06816901: Measuring Lactation Initiation After Early Postpartum Injectable Progestin (DMPA) Use Among Women in Dhanusha District of Nepal: A Pilot Study
Official title: Measuring Lactation Initiation After Early Postpartum Injectable Progestin (DMPA) Use Among Women in Dhanusha District of Nepal: A Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Postpartum Contraception
Depot Medroxyprogesterone Acetate
Lactation
DMPA
Keywords: Depo
Injectable contaception
postpartum
contraception
family planning
DMPA
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Center for Research on Environment, Health and Population Activities
First posted: 2025-02-10
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Enrollment feasibility
timeFrame: 12 weeks
Secondary outcomes:
measure: Time to lactogensis
timeFrame: 148 hours
measure: Exclusive lactation
timeFrame: 12 weeks
measure: DMPA Continuation
timeFrame: 12 weeks
measure: Change in infant weight
timeFrame: Birth to 4 weeks
measure: Change in infant length
timeFrame: Birth to 4 weeks
measure: Change in infant head circumference
timeFrame: Birth to 4 weeks
Other outcomes:
Locations:
city: Janakpur
country: Nepal
facility: Provincial Hospital Janakpur of Dhanusha district
state: Dhanusha district
Study officials:
affiliation: University of California, San Diego
name: Sarah Averbach, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References: