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Group prenatal care may ease depression and prevent preterm birth in black mothers

NCT ID NCT04838210

Symptom relief Sponsor: Washington University School of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a group prenatal care program called EleVATE GC for African-American women at high risk for postpartum depression. The program aims to reduce depression, preterm birth, and low birthweight by providing support and addressing stress. Researchers will compare outcomes for 416 women who receive either group or standard prenatal care.

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

416 people

The number who actually took part.

Started

May 2021

Expected to finish

Jun 2026

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

13 years and older

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: * English or Spanish speaking * ≤18 weeks' gestation * Established prenatal care at EleVATE site * High-risk for postpartum depression by ≥1 risk factor (personal/family history, baseline EPDS≥10, low-income, 13-19 years old, single, history of physical/sexual abuse, unplanned/undesired pregnancy, history of pregnancy loss) * Ability to attend group prenatal visits at specified days/times * Willingness to be randomized * Ability to give informed consent * Any patient that has received prenatal care in a group setting previously Exclusion Criteria: * Multiple gestation * Major fetal anomaly * Serious medical co-morbidity/psychiatric illness necessitating more care than can be safely provided in group setting * Serious medical co-morbidity necessitating more care than can be safely provided in group setting

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Conditions

The condition(s) this trial relates to.

pregnancy disorder perinatal asphyxia prevention target

As listed by the trial registrant

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

Perinatal depression Pregnancy related

Contacts and locations

Locations

  • Affinia Healthcare

    St Louis, Missouri, 63104, United States

  • CareSTL Health

    St Louis, Missouri, 63112, United States

  • Family Care Health Centers

    St Louis, Missouri, 63111, United States

  • University of Missouri-Kansas City/Truman Health Centers-Kansas City

    Kansas City, Missouri, 64108, United States

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