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Behavioral Intervention

Community Health Worker Support for Preeclampsia (AW2H Trial)

N/A
Recruiting
Led By jesse E Rattan
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Between 16-56 years old
Be younger than 65 years old
Must not have
Declines Randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-12 weeks postpartum
Awards & highlights
No Placebo-Only Group

Summary

This trial will focus on helping Black women who have experienced complications during pregnancy, such as preeclampsia. The study aims to see if a program involving community health workers can help improve blood pressure

Who is the study for?
This trial is for Black individuals between the ages of 16-56 who are experiencing adverse pregnancy outcomes like preeclampsia, preterm birth, and others. Participants must be planning to deliver at UAB Hospital, speak and write English, and not be due for delivery at enrollment.
What is being tested?
The study is testing if adding a community health worker intervention to usual postpartum care can better control blood pressure after childbirth and help prevent heart disease later on in Black patients with adverse pregnancy outcomes.
What are the potential side effects?
Since this trial involves standard postpartum care plus additional support from community health workers rather than medication or medical procedures, there are no direct side effects associated with the interventions being tested.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 16 and 56 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I choose not to be randomly assigned to a treatment group.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-12 weeks postpartum
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-12 weeks postpartum for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acceptability
Secondary study objectives
Measure: Mean Blood Pressure
Measure: Primary Care Visit Scheduled
Patient satisfaction with CHW intervention

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Usual care and community health worker interventionExperimental Treatment2 Interventions
Usual postpartum care and community health worker visits and support
Group II: Usual CareExperimental Treatment1 Intervention
Usual postpartum care

Find a Location

Who is running the clinical trial?

National Center for Advancing Translational Sciences (NCATS)NIH
377 Previous Clinical Trials
412,967 Total Patients Enrolled
University of Alabama at BirminghamLead Sponsor
1,655 Previous Clinical Trials
2,444,098 Total Patients Enrolled
American Heart AssociationOTHER
346 Previous Clinical Trials
4,971,117 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,840 Previous Clinical Trials
8,172,058 Total Patients Enrolled
jesse E RattanPrincipal InvestigatorUniversity of Alabama at Birmingham
Jesse E RattanPrincipal InvestigatorUniversity of Alabama at Birmingham
~38 spots leftby Jul 2025
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