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Clinical Trials/NCT06353256
NCT06353256
Completed
Not Applicable

Alabama Womb 2 Heart Solution (AW2H): A Community Health Worker Intervention to Improve Short- and Long-term Outcomes in Black Patients With Adverse Pregnancy Outcomes

University of Alabama at Birmingham2 sites in 1 country61 target enrollmentSeptember 3, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preeclampsia Postpartum
Sponsor
University of Alabama at Birmingham
Enrollment
61
Locations
2
Primary Endpoint
Acceptability
Status
Completed
Last Updated
7 months ago

Overview

Brief Summary

United States maternal mortality and preterm birth rates are among the highest among high-income countries due in part to a combination of racial, regional and socioeconomic disparities in access to care and overall health. The research proposed focuses on adapting and expanding a perinatal community health worker intervention for Black postpartum patients with preeclampsia (PE) and other adverse pregnancy outcomes (APOs). Investigators will partner with a community-based organization that trains and deploys community health workers. Investigators will test an intervention for urban and rural Black postpartum patients with APOs to 1) enhance blood pressure control postpartum and 2) promote long-term cardiovascular disease prevention for this underserved population. This pilot study will determine if randomizing and implementing a community health worker intervention tailored to pregnant people experiencing preeclampsia is feasible and found to be acceptable by participants.

Detailed Description

The investigators will adapt a current perinatal community health worker intervention to the unique needs of Black postpartum patients with preeclampsia and other adverse pregnancy outcomes. The investigators will conduct a pilot trial to assess the feasibility and acceptability of the intervention. The hypothesis is that it is possible to randomize eligible patients to the feasibility trial, and the intervention will be acceptable to participants. The investigators will randomize Black postpartum patients with preeclampsia or other adverse pregnancy outcomes to either 1) usual care - cardiovascular disease-prevention education before discharge, or 2) intervention - cardiovascular disease prevention education before discharge plus an adapted community health worker intervention. Following the completion of this project, the investigators intend to conduct a larger postpartum community health worker intervention trial in patients with preeclampsia or other adverse pregnancy outcomes powered to detect a difference in clinically meaningful outcomes, as informed by our existing community advisory board.

Registry
clinicaltrials.gov
Start Date
September 3, 2024
End Date
June 2, 2025
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jesse Rattan

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

Inclusion Criteria

  • Self Identifies as Black
  • Between 16-56 years old
  • Experiencing adverse pregnancy outcomes defined as hypertensive disorders of pregnancy, preterm birth, placental abruption, pregnancy loss, gestational diabetes, small for gestational infant
  • Planning to deliver at UAB Hospital
  • Speaks and writes in English
  • No indication for delivery at the time of enrollment

Exclusion Criteria

  • Declines Randomization
  • Speaks or writes in languages other than English
  • Currently incarcerated

Outcomes

Primary Outcomes

Acceptability

Time Frame: 12 weeks

Participant satisfaction with postpartum support received as part of the study (scaled from 1 to 10).

Secondary Outcomes

  • Patient satisfaction with CHW intervention(6-12 weeks postpartum)
  • Secondary Outcome Measure: Primary Care Visit Scheduled(6-12 weeks postpartum)
  • Secondary Outcome Measure: Mean Blood Pressure(6-12 weeks postpartum)

Study Sites (2)

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