Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure (AW2H)

August 20, 2026 updated by: Jesse Rattan, University of Alabama at Birmingham

Alabama Womb to Heart Solution: A Community-Based Cardiovascular Health Intervention After Hypertension in Pregnancy

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a single-site, two-arm, parallel, randomized controlled efficacy trial conducted at the University of Alabama at Birmingham (UAB), building on the Alabama Womb to Heart Solution (AW2H) feasibility/acceptability pilot (NCT06353256, N=61). Postpartum patients with pregnancy-associated hypertension (gestational hypertension, preeclampsia, eclampsia, hypertension with superimposed preeclampsia, or hemolysis, elevated liver enzymes, and low platelet count [HELLP] syndrome) or stage 2 hypertension (systolic blood pressure [SBP] >=140 mmHg or diastolic blood pressure [DBP] >=90 mmHg) are randomized 1:1 to usual care or usual care plus a 6-month community health worker (CHW) intervention delivered in partnership with ConnectionHealth.

Usual care (both arms) includes brief self-measured blood pressure education, a pregnancy-validated iHealth blood pressure (BP) Cuff Kit (provided through partnership with the Preeclampsia Foundation), and written education on hypertensive disorders of pregnancy and long-term cardiovascular risk. The CHW intervention adds 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), covering home BP monitoring coaching with American College of Obstetricians and Gynecologists (ACOG)-concordant escalation guidance, medication adherence, postpartum and pediatric visit reminders, breastfeeding and contraception counseling, Life's Essential 8 behavior coaching, primary care linkage, mother-baby education, and trauma-informed emotional support.

The primary outcome is mean systolic blood pressure at 6 months post-enrollment (mean of 3 readings taken 1 minute apart with the validated iHealth monitor, following a protocol adapted from the Chronic Hypertension and Pregnancy (CHAP) Maternal Follow-up Study). The trial provides 80% power to detect a 7 mmHg difference in SBP (standard deviation [SD] 14.5, two-sided alpha=0.05) with 138 participants; enrollment of 174 allows for 20% attrition. Analysis follows intent-to-treat principles. Aim 2 comprises qualitative interviews (up to 20 intervention-arm participants) and two focus groups (CHWs/ConnectionHealth leadership; healthcare providers) analyzed thematically to inform future implementation.

Study Type

Interventional

Enrollment (Estimated)

174

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jesse Rattan, PhD, MPH, RN
  • Phone Number: 404-606-3319
  • Email: jrattan@uab.edu

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham (UAB Women and Infants Center)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Postpartum patients with pregnancy-associated hypertension (gestational hypertension, preeclampsia, eclampsia, hypertension with superimposed preeclampsia, or hemolysis, elevated liver enzymes, and low platelet count [HELLP] syndrome) or stage 2 hypertension per American College of Cardiology/American Heart Association (ACC/AHA) guidelines (systolic blood pressure [SBP] >=140 mmHg or diastolic blood pressure [DBP] >=90 mmHg) on two separate occasions at delivery-related hospital discharge or during the postpartum period
  • Delivered in the last six weeks at >=14 weeks gestational age, including pregnancy loss
  • 16-56 years old
  • Speaks and writes in English
  • Delivering at University of Alabama at Birmingham (UAB) Hospital

Exclusion Criteria:

  • Declines randomization
  • Does not speak English
  • Currently incarcerated
  • Currently enrolled in other community health worker studies or services

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual Care
Cardiovascular disease (CVD)-prevention education before hospital discharge from the delivery-associated hospitalization, including brief self-measured blood pressure (BP) education, a pregnancy-validated iHealth BP Cuff Kit, and written education on hypertensive disorders of pregnancy, long-term cardiovascular risk, and postpartum danger signs.
Other: Usual postpartum care with self-measured blood pressure education and home blood pressure monitor
Standardized self-measured blood pressure (SMBP) education and a pregnancy-validated iHealth blood pressure (BP) Cuff Kit provided before hospital discharge, plus written educational materials on hypertensive disorders of pregnancy and other adverse pregnancy outcomes, long-term cardiovascular disease (CVD) risk, and postpartum danger signs.
Experimental: Usual Care + Alabama Womb to Heart Solution (AW2H) Community Health Worker Program
Usual care (as in Arm 1) plus enrollment in the Alabama Womb to Heart Solution (AW2H) community health worker (CHW) program for 6 months.
Other: Usual postpartum care with self-measured blood pressure education and home blood pressure monitor
Standardized self-measured blood pressure (SMBP) education and a pregnancy-validated iHealth blood pressure (BP) Cuff Kit provided before hospital discharge, plus written educational materials on hypertensive disorders of pregnancy and other adverse pregnancy outcomes, long-term cardiovascular disease (CVD) risk, and postpartum danger signs.
Behavioral: Alabama Womb to Heart Solution (AW2H) Community Health Worker (CHW) Program
Six-month community health worker (CHW) program delivered in partnership with ConnectionHealth. Visit/contact frequency: Approximately 2 times/week for weeks 1-5, weekly for weeks 6-12, and monthly for weeks 13-26; visits may be in person or virtual (phone/video). CHWs coach home blood pressure monitoring with American College of Obstetricians and Gynecologists (ACOG)-concordant escalation guidance, reinforce antihypertensive medication adherence, educate on postpartum danger signs and long-term cardiovascular risk, remind about postpartum and pediatric visits, counsel on breastfeeding and contraception, coach on American Heart Association (AHA) Life's Essential 8 behaviors, assist with scheduling and attending a primary care appointment, provide mother-baby guidance (safe sleep, immunizations, developmental milestones), and offer trauma-informed emotional support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic Blood Pressure (SBP)
Time Frame: 6 months post-enrollment
Mean systolic blood pressure in mmHg, calculated as the mean of 3 readings taken 1 minute apart using a pregnancy-validated iHealth home blood pressure monitor, following a standardized measurement protocol during an in-person or coordinator-observed virtual visit.
6 months post-enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diastolic Blood Pressure (DBP)
Time Frame: 6 months post-enrollment
Mean diastolic blood pressure in mmHg, calculated as the mean of 3 readings taken 1 minute apart using the same standardized protocol as the primary outcome.
6 months post-enrollment
Scheduling of a Primary Care Visit
Time Frame: By 6 months post-enrollment
Proportion of participants with integration into primary care, defined as participant self-report of a scheduled primary care visit.
By 6 months post-enrollment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Arterial Blood Pressure (MAP)
Time Frame: 6 months post-enrollment
Mean arterial blood pressure in mmHg, derived from blood pressure readings taken using the same standardized protocol as the primary outcome.
6 months post-enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Preeclampsia Foundation
ConnectionHealth

Investigators

  • Principal Investigator: Jesse Rattan, PhD, MPH, RN, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 31, 2026

Primary Completion (Estimated)

July 30, 2029

Study Completion (Estimated)

July 30, 2030

Study Registration Dates

First Submitted

August 18, 2026

First Submitted That Met QC Criteria

August 18, 2026

First Posted (Actual)

August 21, 2026

Study Record Updates

Last Update Posted (Actual)

August 24, 2026

Last Update Submitted That Met QC Criteria

August 20, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-300016824
  • K12AR086524 (U.S. NIH Grant/Contract)
  • Build Up Trust Challenge Award (Other Grant/Funding Number: National Institutes of Health)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data underlying published results may be made available to qualified investigators on reasonable request to the Principal Investigator, subject to a data use agreement and any institutional approvals required at the time of the request. Sharing will be limited to uses consistent with the consent provided by participants.

IPD Sharing Time Frame

Beginning after publication of the primary study results. Requests will be considered on an ongoing basis thereafter.

IPD Sharing Access Criteria

Requests should be submitted in writing to the Principal Investigator and will be reviewed on a case-by-case basis. Access requires a data use agreement and any institutional approvals required at the time of the request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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