A Community Health Worker Intervention to Address Adverse Pregnancy Outcomes (AW2H)

The University of Alabama at Birmingham

Status: Completed

Conditions: Adverse Pregnancy Outcomes; Preeclampsia Postpartum

Treatments: Behavioral: usual postpartum care; Behavioral: usual postpartum care + community health worker intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06353256

300012607

24POST1198805 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: Female

Ages: 16 to 56 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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61 participants in 2 patient groups

Usual Care

Experimental group

Description:

Usual postpartum care

Treatment:

Behavioral: usual postpartum care

Usual care and community health worker intervention

Experimental group

Description:

Usual postpartum care and community health worker visits and support

Treatment:

Behavioral: usual postpartum care + community health worker intervention