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Completed

NCT Number: NCT06816901

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Provincial Hospital Janakpur of Dhanusha district

Janakpur Dham, Dhanusha District, Nepal

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Depo Medroxyprogesterone acetate

Drug

Initiation of injectable depo medroxyprogesterone acetate (DMPA) contraception within 48 hours after birth

Other names: DMPA, Injectable contraception

Primary outcomes

  1. Enrollment feasibility

    Time frame: 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 outcomes

  1. Time to lactogensis

    Time frame: 148 hours

    Amount of time (in hours) from birth to lactogenesis

  2. Exclusive lactation

    Time frame: 12 weeks

    Proportion of participants who report exclusive lactation without supplementation

  3. DMPA Continuation

    Time frame: 12 weeks

    The proportion of participants who use DMPA continuously for 12 weeks and return for a second dose

  4. Change in infant weight

    Time frame: Birth to 4 weeks

    Infant weight in grams will be compared over 4 weeks

  5. Change in infant length

    Time frame: Birth to 4 weeks

    Infant length in millimeters will be compared over 4 weeks

  6. Change in infant head circumference

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • Center for Research on Environment, Health and Population Activities

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 10, 2025
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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