A healing hand: could Doula-Midwife teams transform postpartum recovery for NICU moms?
NCT ID NCT07787845
First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time
Summary
This trial tests whether a coordinated care approach—where doulas provide continuous emotional and physical support and nurse-midwives deliver specialized postpartum care—can improve health outcomes for mothers whose babies are born before 34 weeks and admitted to the NICU. Participants will be randomly assigned to receive either this integrated support or standard postpartum care. The study will measure how quickly mothers receive postpartum care, their mental health, and their overall well-being in the months after birth.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Doula-coordinated, midwife-delivered postpartum care
- What this could lead to
- If effective, this integrated care model could reduce postpartum complications, improve mental health, and enhance recovery for mothers of preterm infants.
- What could go wrong
- This is a behavioral intervention, so results may vary by setting and participant engagement. The trial is not a drug study, so benefits may be modest and depend on implementation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 350 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age above 18 at time of delivery of infant * English-speaking * Medicaid insurance coverage at the time of delivery, either as primary or secondary coverage * Delivery before 34 weeks' gestation * Infant admitted to the NICU, 10 days old or less Exclusion Criteria: * Stillbirth * Infant death in the delivery room * Infant with severe congenital anomalies expected to result in death shortly after birth * Inability to provide informed consent * Inability to visit the infant in the NICU at least once per week * More than 10 days postpartum
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Prisma Health Richland
Columbia, South Carolina, 29203, United States
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