NCT06335381: MOMs-CC

MOMs Chat and Care Study

Recruiting now NA Last updated 7 January 2026

What this trial tests

NA trial testing Northwell Pregnancy & Peds Chats in Severe Maternal Morbidity in 674 participants. Currently enrolling.

Timeline

28 May 2024

Primary endpoint
31 December 2027

30 June 2028

Quick facts

Lead sponsor	Northwell Health
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	674
Start date	28 May 2024
Primary completion	31 December 2027
Estimated completion	30 June 2028
Sites	1 location across United States

Drugs / interventions tested

• Northwell Pregnancy & Peds Chats
• Prenatal Telehealth Visits
• Postpartum Telehealth Visits
• Home Blood Pressure Monitor
• Fitbit

Conditions studied

• Severe Maternal Morbidity — all drugs for Severe Maternal Morbidity →

Sponsor

Northwell Health — full company profile →

Who can join

Adults 18 to 50, female only, with Severe Maternal Morbidity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. MOMs Chat & Care Study: Rationale and design of a pragmatic randomized clinical trial to prevent severe maternal morbidity among Black birthing people.
   Fitzpatrick SL, Polo J, Ephraim P, Vrany E, et al · · 2025 · cited 1× · PMID 39987957 · DOI 10.1016/j.cct.2025.107850