Postpartum ContraceptionPhase 4NCT06816901
Measuring Lactation Initiation After Early Postpartum Injectable Progestin (DMPA) Use Among Women in Dhanusha District of Nepal: A Pilot Study
A Phase 4 study testing Depo Medroxyprogesterone acetate in people with Postpartum Contraception and Depot Medroxyprogesterone Acetate, run by University of California, San Diego at 1 site in Nepal.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Contraception, Depot Medroxyprogesterone Acetate, Lactation
- What is being tested?
- Depo Medroxyprogesterone acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNepal
- Study dates
- 26 Mar 2025to 31 Jul 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Nepal1 site
Provincial Hospital Janakpur of Dhanusha district
Janakpur Dham, Dhanusha District
About this 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.
Read the 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.
- Being tested
- Depo Medroxyprogesterone acetate
- Keywords
- Depo, Injectable contaception, postpartum, contraception, family planning, DMPA
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depo Medroxyprogesterone acetateDrug
Also called DMPA, Injectable contraception
Initiation of injectable depo medroxyprogesterone acetate (DMPA) contraception within 48 hours after birth
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Initiation of injectable depo medroxyprogesterone acetate (DMPA) within 48 hours of birth Receives: Drug: Depo Medroxyprogesterone acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (6)
Time to lactogensis
Amount of time (in hours) from birth to lactogenesis
Measured: 148 hours
Exclusive lactation
Proportion of participants who report exclusive lactation without supplementation
Measured: 12 weeks
DMPA Continuation
The proportion of participants who use DMPA continuously for 12 weeks and return for a second dose
Measured: 12 weeks
Change in infant weight
Infant weight in grams will be compared over 4 weeks
Measured: Birth to 4 weeks
Change in infant length
Infant length in millimeters will be compared over 4 weeks
Measured: 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
Measured: Birth to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start26 Mar 2025
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Research on Environment, Health and Population Activities
- Responsible party
- Principal investigator, Sarah Averbach, MD MAS, University of California, San Diego
- Investigators
- Sarah Averbach, MD, MAS, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06816901
- Sponsor's protocol ID
- 811161
- Status last verified
- Sep 2025
- First submitted
- 4 Feb 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Lactation Initiation After Early Postpartum Injectable Progestin (DMPA) Use Among Women in Dhanusha District of Nepal: A Pilot Study
- ClinicalTrials.gov ID
- NCT06816901
- Acronym / sponsor ID
- 811161
- Keywords
- Depo, Injectable contaception, postpartum, contraception, family planning, DMPA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Center for Research on Environment, Health and Population Activities
- Study start
- 26 Mar 2025 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Depo Medroxyprogesterone acetateInitiation of injectable depo medroxyprogesterone acetate (DMPA) within 48 hours of birth |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Depo Medroxyprogesterone acetateAlso: DMPA, Injectable contraceptionInitiation of injectable depo medroxyprogesterone acetate (DMPA) contraception within 48 hours after birth | Drug | Intervention |
Primary outcome
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.
6 secondary outcomes
Time to lactogensis
Time frame: 148 hours
Exclusive lactation
Time frame: 12 weeks
DMPA Continuation
Time frame: 12 weeks
Change in infant weight
Time frame: Birth to 4 weeks
Change in infant length
Time frame: Birth to 4 weeks
Change in infant head circumference
Time frame: Birth to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Averbach, MD, MAS principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Depo Medroxyprogesterone acetate in people with Postpartum Contraception and Depot Medroxyprogesterone Acetate, run by University of California, San Diego at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment feasibility (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025; AzTrials last refreshed its copy on 27 Oct 2026.