Community Health Worker Support for Postpartum Hypertension

(AW2H Trial)

JR
Overseen ByJesse Rattan, PhD, MPH, RN
Age: < 65
Sex: Female
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

High blood pressure during or after pregnancy (such as preeclampsia, gestational hypertension, eclampsia, or Hemolysis, Elevated Liver enzymes, and Low Platelet (HELLP) syndrome) raises a mother's risk of heart disease later in life. Many patients do not return for follow-up care after delivery, missing a key window to protect their heart health. The Alabama Womb to Heart Solution (AW2H) trial will test whether pairing postpartum patients with a trained community health worker (CHW) for 6 months lowers blood pressure compared with usual care.

A total of 174 postpartum patients who had pregnancy-associated hypertension or stage 2 high blood pressure will be randomly assigned (1:1) to usual care or usual care plus the AW2H CHW program. All participants receive education on measuring their own blood pressure and a pregnancy-validated home blood pressure monitor. Participants in the CHW group are also contacted regularly by a CHW for 6 months. CHWs coach home blood pressure monitoring, support taking blood pressure medications as prescribed, encourage heart-healthy habits based on the American Heart Association's Life's Essential 8 (LE8), help schedule a primary care visit, provide mother-baby education (such as safe sleep and immunizations), and offer emotional support.

The main outcome is systolic blood pressure 6 months after enrollment, measured at home with the study-provided monitor while a research coordinator observes in person or by video/phone. The study will also look at diastolic blood pressure and whether participants scheduled a primary care visit. Interviews and focus groups will explore participant, CHW, and provider experiences with the program.

Who Is on the Research Team?

JR

Jesse Rattan, PhD, MPH, RN

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for English-speaking women aged 16-56 who delivered at UAB Hospital in the last six weeks (including pregnancy loss) and had high blood pressure during or after pregnancy. They must not be incarcerated, already in similar studies, or unwilling to be randomly assigned.

Inclusion Criteria

Speaks and writes in English
I am between 16 and 56 years old.
Delivered in the last six weeks at >=14 weeks gestational age, including pregnancy loss
See 2 more

Exclusion Criteria

Does not speak English
Currently incarcerated
Currently enrolled in other community health worker studies or services
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive usual care or usual care plus the AW2H CHW program for 6 months

6 months
Visits or contacts approximately 2 times per week for weeks 1-5, weekly for weeks 6-12, and monthly for weeks 13-26 (in person or virtual)

Follow-up

Participants are monitored for systolic and diastolic blood pressure, and integration into primary care is assessed

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Alabama Womb to Heart Solution (AW2H) Community Health Worker (CHW) Program

Trial Overview

The study compares usual postpartum care with self-blood pressure monitoring versus the same care plus regular support from a trained community health worker for six months. Participants are randomly placed into one of these two groups.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Usual Care + Alabama Womb to Heart Solution (AW2H) Community Health Worker ProgramExperimental Treatment2 Interventions
Group II: Usual CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials
508
Recruited
1,090,000+

ConnectionHealth

Collaborator

Trials
2
Recruited
440+

Preeclampsia Foundation

Collaborator

Trials
4
Recruited
50,900+