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NCT06335381 · ClinicalTrials.gov registry record · NA
MOMs Chat and Care Study
A NA study of Severe Maternal Morbidity, sponsored by Northwell Health.
- Recruiting
- Registry status
- NA
- Development phase
- 674
- Enrollment target
- 1
- Study location
NCT06335381: Recruiting NA study of Severe Maternal Morbidity, sponsored by Northwell Health.
NCT06335381 is a NA study of Severe Maternal Morbidity that is actively recruiting participants, run by Northwell Health. The registered enrollment target is 674 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (52% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06335381, a NA study of Severe Maternal Morbidity, is actively recruiting participants, sponsored by Northwell Health.
- RECRUITING
- Registry status
- NA
- Development phase
- 674 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
The Centers for Disease Control \& Prevention define SMM as having ≥ 1 ICD-10 diagnosis codes that correspond to 21 SMM indicators. SMM indicator diagnoses that occur at labor and delivery, from delivery to 1-month postpartum during a hospital admission, or from delivery to 1-year postpartum during a hospital admission will be extracted from the electronic health record.
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 |
What NCT06335381 shows while recruiting
NCT06335381 is an interventional study that assigns participants to a tested intervention. The registered 674 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (52% lower).
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.
NCT06335381 reports a single indexed study location in New York.
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.
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).
Who is sponsoring clinical trial NCT06335381?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
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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Where NCT06335381's enrollment target sits among peer trials
674 151st of 2000 higher than 1,850 of 2,000 other NA trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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