MOMs Chat & Care Study: Rationale and design of a pragmatic randomized clinical trial to prevent severe maternal morbidity among Black birthing people.
Stephanie L Fitzpatrick, Jennifer Polo, Patti Ephraim...
https://pubmed.ncbi.nlm.nih.gov/39987957Actively Recruiting
Phase Not Applicable
Age: 18Years - 50Years
FEMALE
ID06335381
Maternal OutcoMes (MOMs) Program: Testing Integrated Maternal Care Model Approaches to Reduce Risk of Severe Maternal Morbidity
Led by Northwell Health · Updated on 2026-05-07
674
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
N
Northwell Health
Lead Sponsor
N
National Institute of Nursing Research (NINR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate how well two different levels of an integrated care model work to provide timely and appropriate care to reduce the risk of Severe Maternal Morbidity (SMM) in Black and Hispanic pregnant patients. Women with an Obstetrics-Comorbidity Index Score of 2 or higher and/or a history of pre-eclampsia are included. The study will compare the effects of these care approaches on the occurrence of SMM at labor and delivery, hospitalizations related to SMM up to one year postpartum, timing of preeclampsia diagnosis and treatment, social support changes, and physical activity patterns. Researchers will also explore factors that help or hinder implementing this care model. Participants will be randomly assigned to one of two groups: MOMs High-Touch (MOMs-HT) or MOMs Low-Touch (MOMs-LT). MOMs-HT offers maternal health education via digital apps, frequent telehealth support visits during pregnancy, home blood pressure monitoring, and postpartum telehealth check-ins up to six weeks after delivery. MOMs-LT provides education through digital apps, fewer postpartum telehealth visits with navigation support, and a Fitbit to track physical activity. Both groups receive a Fitbit to monitor their physical activity throughout the study. During the study, participants will complete questionnaires on social support and wear the Fitbit to track physical activity. Their health data, including diagnoses of SMM and preeclampsia, will be gathered from electronic health records. The study will also use interviews to understand how well the care model is implemented. The total participation covers pregnancy through one year postpartum with regular assessments to monitor outcomes and support participant health.
CONDITIONS
Brief Title
MOMs Chat and Care Study
Who Can Participate
Age: 18Years - 50Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Age 18 or older
- Self-identify as Black/African American or Hispanic/Latina
- Pregnant and less than 17 weeks gestational age
- Obstetrics-Comorbidity Index Score of 2 or higher and/or history of preeclampsia
- English or Spanish as primary language
- Receive care at Northwell Health Physician Partners obstetrics practice site
You will not qualify if you...
- Unable to provide informed consent due to cognitive or psychiatric impairment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Prenatal Treatment
Duration - Up to approximately 9 months (from enrollment to labor and delivery)
Participants receive maternal health education resources and support through digital applications. Those in the MOMs High-Touch arm have up to 12 bi-weekly self-management support telehealth visits with a care management coordinator or nurse, which include clinical and behavioral health check-ins, navigation to services, and self-management support. Participants use a home blood pressure monitor to track their blood pressure regularly and a Fitbit to monitor physical activity.
Up to 12 bi-weekly telehealth visits for MOMs High-Touch; no scheduled telehealth visits for MOMs Low-Touch during this period
Postpartum Treatment
Duration - Up to 6 weeks postpartum
Participants receive 5 bi-weekly postpartum telehealth clinical check-in visits with navigation support to clinical, behavioral, and social services as needed. These visits include screening for symptoms, depression, and anxiety, and reminders about medical appointments. Participants continue using the Fitbit and, if applicable, follow blood pressure monitoring recommendations.
5 bi-weekly telehealth visits
Follow-up Monitoring
Duration - Up to 1 year postpartum
Participants are monitored for severe maternal morbidity and other health outcomes through electronic health records and questionnaires assessing social support and physical activity at baseline, 1 month postpartum, and 1 year postpartum.
3 assessment timepoints (baseline, 1 month postpartum, 1 year postpartum); questionnaires and data collection
Trial Site Locations
Total: 1 location
1
Northwell Health
Manhasset, New York, United States, 11030
Actively Recruiting
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Research Team
S
Stephanie L Fitzpatrick, PhD
L
Lizcary Amarante, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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