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Can community navigators save black Mothers' lives? new trial aims to find out

NCT ID NCT05588245

Disease control Sponsor: Emory University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether community-based patient navigators can improve maternal health for Black women in a safety-net health system. 540 pregnant women with unmet social needs will be randomly assigned to receive either standard care or extra support from a navigator from mid-pregnancy through 12 months after birth. The goal is to reduce severe complications and deaths related to pregnancy.

What this could mean

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

Active substance
community-based patient navigation
What this could lead to
If effective, this program could become a standard way to improve maternal health outcomes and reduce racial disparities for high-risk Black women.
What could go wrong
This is a pragmatic trial testing a behavioral intervention, not a drug or device. Results may vary across different healthcare settings, and the study is still recruiting.

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 540 people

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

Started

Jan 2024

Expected to finish

Jun 2027

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

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * A pregnant woman or individual (inclusive of all gender identities) who is Black and English-speaking (by self-report), * ≥18 years of age who is capable of consenting for oneself and who presents for prenatal care with a singleton pregnancy ≤ 20 weeks gestation (confirmed by medical record), * covered by Medicaid * for whom the AHC-Health Related Social Needs Tool (administered as part of standard clinical care for prenatal patients) identifies ≥1 unmet social needs * expectation to receive prenatal care and deliver at Grady and be available through 12-months postpartum to assure opportunity for exposure to the intervention, process, and outcome measure ascertainment. Exclusion Criteria: * The intent to transfer care to a health system outside of metro Atlanta * incarceration, which would interfere with intervention provision and outcome ascertainment * adults unable to give consent * individuals who are not yet adults * prisoners * cognitively impaired individuals with impaired decision-making capacity * individuals who are not able to clearly understand and speak English (as the PPP-PN intervention is only available in English at this time)

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Conditions

The condition(s) this trial relates to.

pregnancy disorder

As listed by the trial registrant

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

Pregnancy related

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

  • Grady Memorial Hospital

    RECRUITING

    Atlanta, Georgia, 30303, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.