New study aims to prevent Life-Threatening birth complications in black and hispanic mothers
NCT ID NCT06335381
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests two integrated care models (high-touch vs. low-touch) to see if they can reduce severe maternal morbidity in Black and Hispanic pregnant women at high risk. About 674 participants will be randomly assigned to one of the two approaches early in pregnancy. The goal is to improve timely care and reduce complications during and after delivery.
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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 674 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Jun 2028
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 to 50 years
- 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 18 or older, * Self-identify as Black/African American or Hispanic/Latina (includes Black + another race; Black or Afro Hispanic/Latina; or Hispanic/Latina), * Pregnant, less than 17 weeks gestational age, * OB-CMI risk score ≥ 2 and/or history or preeclampsia, * English or Spanish as primary language, and * Receive care at Northwell Health Physician Partners obstetrics practice site. Exclusion Criteria: • Pregnant women who are not able to provide informed consent due to cognitive or psychiatric impairment. If interested in participating in the study, please visit https://www.momschatandcare.com/
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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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Northwell Health
RECRUITINGManhasset, New York, 11030, United States
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