| NCT ID | NCT06335381 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northwell Health |
| Condition | Severe Maternal Morbidity |
| Study Type | INTERVENTIONAL |
| Enrollment | 674 participants |
| Start Date | 2024-05-28 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 674 participants in total. It began in 2024-05-28 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to test the effectiveness of an integrated care model approach at two different levels of intensity designed to facilitate timely, appropriate care to reduce risk for SMM. Black and Hispanic pregnant patients with an Obstetrics-Comorbidity Index Score ³ greater than or equal to 2 and/or a history of pre-eclampsia will be identified via the electronic health record and 674 will be recruited and randomized early during pregnancy to one of two study arms: MOMs High-Touch (MOMs-HT) vs. MOMs Low-Touch (MOMs-LT). The two study arms will be compared on incidence of SMM at labor and delivery (Aim 1), incidence rate of SMM-related hospitalizations at 1-month and 1-year postpartum (Aim 1a), time to preeclampsia diagnosis and initiation of treatment (Aim 2), change in perceived social support domains (Aim 3), and physical activity trajectories (exploratory Aim 4). Mixed methods will also be used to examine facilitators and barriers to implementation (Aim 5). Findings from this study will help to determine how to feasibly implement an effective and sustainable integrated care approach to reduce risk for SMM.
Eligibility 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/
Contact & Investigator
Stephanie L Fitzpatrick, PhD
PRINCIPAL INVESTIGATOR
Northwell Health
Frequently Asked Questions
Who can join the NCT06335381 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Severe Maternal Morbidity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06335381 currently recruiting?
Yes, NCT06335381 is actively recruiting participants. Contact the research team at sfitzpatrick1@northwell.edu for enrollment information.
Where is the NCT06335381 trial being conducted?
This trial is being conducted at Manhasset, United States.
Who is sponsoring the NCT06335381 clinical trial?
NCT06335381 is sponsored by Northwell Health. The principal investigator is Stephanie L Fitzpatrick, PhD at Northwell Health. The trial plans to enroll 674 participants.