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A Community Health Worker Intervention to Address Adverse Pregnancy Outcomes

NCT06353256 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2025-09-30

No results posted yet for this study

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.

Conditions

  • Preeclampsia Postpartum
  • Adverse Pregnancy Outcomes

Interventions

BEHAVIORAL

usual postpartum care

Usual clinical and educational postpartum care

BEHAVIORAL

usual postpartum care + community health worker intervention

participants will receive routine care and also community health worker support and visits.

Sponsors & Collaborators

  • American Heart Association

    collaborator OTHER

  • National Institutes of Health (NIH)

    collaborator NIH

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Jesse E Rattan · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
56 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-03
Primary Completion
2025-06-02
Completion
2025-06-02

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06353256 on ClinicalTrials.gov