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NCT Number: NCT06353256

A Community Health Worker Intervention to Address Adverse Pregnancy Outcomes

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.

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Key information

Conditions

Preeclampsia Postpartum Adverse Pregnancy Outcomes Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

16 year–56 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

The investigators will adapt a current perinatal community health worker intervention, lead by a leading community health worker organization, Connection Health, 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 Connection Health 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 (loss at greater or equal to 14 weeks gestation), gestational diabetes, delivering a small for gestational age infant
  • Planning to deliver at UAB Hospital
  • Speaks and writes in English

Exclusion criteria

  • Declines Randomization
  • Speaks or writes in languages other than English
  • Currently incarcerated
  • Previously enrolled in P3OPPY

Treatment and study plan

usual postpartum care

Behavioral

Usual clinical and educational postpartum care

usual postpartum care + community health worker intervention

Behavioral

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

Primary outcomes

  1. Acceptability

    Time frame: 12 weeks

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

Secondary outcomes

  1. Patient satisfaction with CHW intervention

    Time frame: 6-12 weeks postpartum

    Patient satisfaction with CHW intervention using Sekhon Questionnaire to Assess the Acceptability of Healthcare Interventions, 1-5 scale with 1 being the lowest acceptability to 5 being the highest acceptability.

  2. Secondary Outcome Measure: Primary Care Visit Scheduled

    Time frame: 6-12 weeks postpartum

    Participant reports at least one visit is scheduled with a primary care provider

  3. Secondary Outcome Measure: Mean Blood Pressure

    Time frame: 6-12 weeks postpartum

    Mean blood pressure at 6-12 weeks postpartum

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • American Heart Association
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Acronym: AW2H

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 9, 2024
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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