Integrated care model for high-risk Black and Hispanic/Latina birthing people
Official title: Maternal OutcoMes (MOMs) Program: Testing Integrated Maternal Care Model Approaches to Reduce Risk of Severe Maternal Morbidity
Run by Northwell Health · NCT06335381 · Data updated 2026-11-12
This study tests if a new care approach with more support can help high-risk Black and Hispanic/Latina birthing people have safer pregnancies and reduce serious health problems.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 674 (estimated) |
| Sponsor | Northwell Health Academic / other |
| Locations | 1 site (Manhasset, New York) |
| Status | Recruiting |
| Started | May 28, 2024 |
| Main results expected | December 31, 2027 |
| Study ends | June 30, 2028 |
| Registry record updated | May 7, 2026 |
| Trial ID | NCT06335381 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are Black or Hispanic/Latina individuals who are pregnant and less than 17 weeks gestational age with a high-risk OB-CMI score.
✕Probably not a fit
Patients who cannot provide informed consent due to cognitive or psychiatric impairments will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the effectiveness of an integrated care model designed for high-risk Black and Hispanic/Latina birthing individuals to reduce severe maternal morbidity (SMM). Participants will be randomized into two groups: one receiving high-touch care with extensive monitoring and support, and the other receiving low-touch care with basic monitoring. The study will assess various outcomes, including the incidence of SMM during labor and delivery, hospitalizations related to SMM, and the effectiveness of interventions in improving social support and physical activity. Mixed methods will also be employed to identify barriers and facilitators to implementation.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of severe maternal morbidity among high-risk populations.
How similar studies have gone: Other studies have shown promise in using integrated care models for maternal health, but this specific approach is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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/
Where it's running
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Northwell Health
Manhasset, New York, United States Recruiting
Study contacts
- Principal investigator: Stephanie L Fitzpatrick, PhD — Northwell Health
- Study coordinator: Stephanie L Fitzpatrick, PhD
- Email: sfitzpatrick1@northwell.edu
- Phone: 646-766-7167
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.