Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06353256 |
| Other study ID # |
300012607 |
| Secondary ID |
UL1TR00309624POS |
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2024 |
| Est. completion date |
July 31, 2025 |
Study information
| Verified date |
May 2024 |
| Source |
University of Alabama at Birmingham |
| Contact |
Jesse E Rattan, PhD |
| Phone |
205-934-5611 |
| Email |
jrattan[@]uab.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
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.
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.
