NCT06353256

A Community Health Worker Intervention to Address Adverse Pregnancy Outcomes

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: Female
• Age: 16 Years – 56 Years
• Healthy volunteers: Accepted

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, 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.

Conditions

• Preeclampsia Postpartum
• Adverse Pregnancy Outcomes

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-09-03
• Primary completion: 2025-06-02
• Completion: 2025-06-02
• First posted: 2024-04-09
• Last updated: 2025-09-30

Locations

2 sites across 1 country: United States