A Phase 4 interventional study of Depo Medroxyprogesterone acetate in Postpartum Contraception, Depot Medroxyprogesterone Acetate and Lactation, sponsored by University of California, San Diego. Completed at 1 site in Nepal. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-10.
Sponsored by University of California, San Diego · Phase 4, Interventional, and Health services research
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.
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.
262 studies on the registry are indexed under Breast Feeding; 112 are open to participants now.
This study's enrollment of 40 is below the median of 95 across 210 interventional studies indexed under Breast Feeding.
Browse Breast Feeding studies →University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.
Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.
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Exclusion Criteria:
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
Also known as: DMPA, Injectable contraception
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.
Time frame: 12 weeks
Time to lactogensis
Amount of time (in hours) from birth to lactogenesis
Time frame: 148 hours
Exclusive lactation
Proportion of participants who report exclusive lactation without supplementation
Time frame: 12 weeks
DMPA Continuation
The proportion of participants who use DMPA continuously for 12 weeks and return for a second dose
Time frame: 12 weeks
Change in infant weight
Infant weight in grams will be compared over 4 weeks
Time frame: Birth to 4 weeks
Change in infant length
Infant length in millimeters will be compared over 4 weeks
Time frame: 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
Time frame: Birth to 4 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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University of California, San Diego