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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05916534
Other study ID # 1R21NR020706-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 20, 2023
Est. completion date August 2024

Study information

Verified date December 2023
Source State University of New York - Downstate Medical Center
Contact Aimee Afable, PHD
Phone 718-270-6397
Email aimee.afable@downstate.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date August 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 49 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
WeCAB Intervention
The WeCAB intervention will use a dedicated WeCAB community health worker who will administer a social determinants of health (SDOH) tool and use digital care navigation to monitor closed loop referrals.

Locations

Country Name City State
United States University Hospital at Downstate Brooklyn New York

Sponsors (1)

Lead Sponsor Collaborator
State University of New York - Downstate Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Initiation of postpartum care Initiation of postpartum care within 6 weeks of delivery 13 weeks until 3 months postpartum
Secondary Maternal death Death of a woman while pregnant or within 42 days of termination of pregnancy, irrespective of the duration and site of the pregnancy, from any cause related to or aggravated by the pregnancy or its management but not from accidental or incidental causes. 13 weeks until 3 weeks postpartum
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