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MOMs Chat and Care Study
NCT06335381 · View on ClinicalTrials.gov ↗
Study 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 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.
Conditions Studied
Interventions
- OTHER Fitbit
- OTHER Northwell Pregnancy & Peds Chats
- BEHAVIORAL Prenatal Telehealth Visits
- OTHER Postpartum Telehealth Visits
- OTHER Home Blood Pressure Monitor
Study Locations (1)
New York
- Northwell Health — Manhasset
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 674 participants |
| Start Date | 2024-05-28 |
| Est. Completion | 2028-06-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06335381
The ClinicalTrials.gov registry entry for NCT06335381 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 674 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwell Health, which has 371 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Severe Maternal Morbidity appearing as the primary indexed condition, and to 5 interventions — of which Fitbit is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06335381 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06335381 about?
NCT06335381 is a clinical study titled "MOMs Chat and Care Study". 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 2 and/or a histor...
What is the current status of trial NCT06335381?
This trial is currently recruiting. It is a NA study. The enrollment target is 674 participants. The study started on 2024-05-28. Estimated completion is 2028-06-30.
What conditions does trial NCT06335381 study?
This clinical trial studies the following conditions: Severe Maternal Morbidity. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06335381?
The interventions under investigation include: Fitbit (OTHER), Northwell Pregnancy & Peds Chats (OTHER), Prenatal Telehealth Visits (BEHAVIORAL), Postpartum Telehealth Visits (OTHER), Home Blood Pressure Monitor (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06335381?
This trial is sponsored by Northwell Health, which has 371 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06335381 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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