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Can data and doulas close the racial gap in maternal care?

NCT ID NCT05484804

Disease control Sponsor: University of North Carolina, Chapel Hill 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This large study in North Carolina tests whether giving clinics data tools and racial equity training, plus offering doula support to high-risk Black patients, can reduce low birthweight and discrimination in prenatal care. About 60,000 patients from 39 clinics will take part. The goal is to find practical ways to reduce Black-White disparities in maternal health.

What this could mean

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

Active substance
Data accountability tools and community-based doula support
What this could lead to
If successful, this could show that combining data transparency with doula support reduces low birthweight and discrimination in prenatal care for Black mothers.
What could go wrong
This is a pragmatic trial testing complex interventions across many clinics, so results may vary by site. The study is large but still observational in nature, and improvements may not be dramatic or easily replicated elsewhere.

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 60,000 people

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

Started

Jun 2023

Expected to finish

Aug 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

12 to 99 years

Sex

Female participants only

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: Practices: * Have at least 180 Black patient deliver over 2 years * Be willing to be randomized * Be willing to adhere to the study protocol Patient survey participants: * Start prenatal care at one of the study clinics during study implementation * Self-identify as Black or African American * Able to give consent and complete surveys and interviews in English Practice staff member participants: * Employed as either a provider, nurse/medical assistant, or office administrator at one of the clinics in this study Doula participants: * Provide doula care to patients at one the clinics in this study Exclusion Criteria: Practices: * Already integrated with Community-Based Doulas * Already have an Early Warning System or Disparities Dashboard

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Conditions

The condition(s) this trial relates to.

Bias, Implicit Maternal Death pregnancy disorder Racism

As listed by the trial registrant

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

Implicit bias Low birthweight Maternal health Maternal mortality Pregnancy related RACISM

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 North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

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