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Clinical Trials/NCT05916534
NCT05916534
Recruiting
Not Applicable

Brooklyn Digital Community Care Intervention to Address Unmet Social Needs and Optimize Engagement in Maternal Health Care

State University of New York - Downstate Medical Center1 site in 1 country80 target enrollmentNovember 20, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Maternal Health
Sponsor
State University of New York - Downstate Medical Center
Enrollment
80
Locations
1
Primary Endpoint
Initiation of postpartum care
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

The goal of this clinical trial is to test a behavioral intervention in pregnant women who identify as Black and live in Central Brooklyn. The main question it aims to answer is whether the WeCAB intervention leads to a net improvement in utilization of postpartum care compared to those receiving usual care.

The WeCAB group will have a dedicated WeCAB community health worker who will be trained in digital care navigation.

Researchers will compare the WeCAB group versus the group receiving usual care to see if the patients randomized to WeCAB will have higher rates of early post-partum care compared to patients in the control group.

Registry
clinicaltrials.gov
Start Date
November 20, 2023
End Date
August 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
State University of New York - Downstate Medical Center
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Eligible participants for the pilot RCT will be patients
  • aged 18-49 years (childbearing age)
  • residing in a Central Brooklyn zip code
  • self-reporting as Black,
  • who speak English or Haitian Creole, and
  • plan to deliver or present for delivery at University Hospital at Downstate (UHD).
  • In NYC, SMM increases incrementally with later entry into prenatal care (1st trimester: 208/10,000 deliveries; 2nd trimester: 252/10,000; 3rd trimester: 297/10,000; None: 575/10,000). 3 Accordingly, in order to capture the full range of SMM risk profiles for our pilot study, any pregnant patient/client visiting our clinics will be eligible for enrollment from 13 weeks gestation through delivery, thus allowing follow-up to 3 months post-partum within the 2-year study timeline.

Exclusion Criteria

  • Patients planning to move outside of New York City in the ensuing 3 months post-partum
  • Patients demonstrating an impairment that limits their ability to provide informed consent.

Outcomes

Primary Outcomes

Initiation of postpartum care

Time Frame: 13 weeks until 3 months postpartum

Initiation of postpartum care within 6 weeks of delivery

Secondary Outcomes

  • Maternal death(13 weeks until 3 weeks postpartum)

Study Sites (1)

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