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Could more doula visits ease postpartum depression?

NCT ID NCT07799805

Disease control Sponsor: University of Florida Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This trial compares two models of doula support for pregnant people on Medicaid in North Central Florida. One group receives enhanced support that starts earlier in pregnancy, happens more often, and continues through the first year after birth. The other group receives standard Medicaid-covered doula care. Researchers want to see if the enhanced model lowers rates of depression and anxiety symptoms during and after pregnancy. The study also trains doulas to become eligible for Medicaid billing, with results intended to inform state policy on doula services.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Enhanced doula support, starting earlier in pregnancy, with more frequent visits and continued support through the first year after birth
What this could lead to
If it works, this could point toward a new standard for Medicaid-covered doula care that reduces postpartum depression and anxiety.
What could go wrong
This is a single-region trial, and results may not apply elsewhere. The intervention depends on building a larger doula workforce, which may be hard to sustain.

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

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

About 516 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

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

15 to 49 years

Sex

Female participants only

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 15-49 years old * 14-28 weeks pregnant * Medicaid Eligible * Resides in North Central Florida Exclusion Criteria: * Severe physical or mental health conditions that Interfere with participation

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Conditions

The condition(s) this trial relates to.

perinatal asphyxia postpartum depression pregnancy disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Doula care Health disparities Maternal adverse outcomes Perinatal anxiety Perinatal depression Post partum Postpartum depression (PPD) Pregnancy Pregnancy complications

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • University of Florida

    Gainesville, Florida, 32610, United States

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