Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06353256
Study type Interventional
Source University of Alabama at Birmingham
Contact Jesse E Rattan, PhD
Phone 205-934-5611
Email jrattan@uab.edu
Status Not yet recruiting
Phase N/A
Start date July 1, 2024
Completion date July 31, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT05534932 - Guideline-directed Management and Therapy (GDMT) for the Prevention of Postpartum Cardiac Dysfunction in Preeclamptic African American Women N/A
Recruiting NCT04632589 - Losartan for Improved Vascular Endothelial Function After Preeclampsia Early Phase 1
Not yet recruiting NCT06373367 - Preeclampsia Educational Program Study (PrEPS) N/A
Recruiting NCT05937841 - Sensitivity of Angiotensin II Type II Receptors in Women Following Preeclampsia Early Phase 1
Recruiting NCT03978767 - Preeclampsia And Nonsteroidal Drugs for Analgesia: a Randomized Non Inferiority Trial Phase 2
Recruiting NCT05924971 - Aspirin for Postpartum Patients With Preeclampsia Phase 2
Recruiting NCT03667326 - Postpartum Low-Dose Aspirin and Preeclampsia Phase 2
Recruiting NCT04479072 - Aspirin and Preeclampsia Phase 4
Completed NCT03451266 - Effects of Vitamin C Administration on Extravascular Lung Water in Patients With Severe Features of Preeclampsia Phase 1