Recruiting

AW2H Program

Sponsor:

University of Alabama at Birmingham

Code:

NCT07778966

Conditions

Pregnancy-Associated Hypertension

Gestational Hypertension

Preeclampsia

Eclampsia

HELLP Syndrome

Eligibility Criteria

Sex: Female

Age: 16 - 56

Healthy Volunteers: Not accepted

Interventions

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

Usual postpartum care with self-measured blood pressure education and home blood pressure monitor

Study Details

Brief summary:

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.

Conditions

Pregnancy-Associated Hypertension

Gestational Hypertension

Preeclampsia

Eclampsia

HELLP Syndrome

Study ID

NCT07778966

Start date

Oct 19, 2026

Status verified date

Oct, 2026

Completion date

Jul 30, 2030

Anticipated

Primary completion date

Jul 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 16 - 56

Healthy Volunteers: Not accepted

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 Design

Enrollment

174 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

Primary outcome measure

  • Systolic Blood Pressure (SBP) [ Time Frame: 6 months post-enrollment ]

Central Contacts and Locations

Central contacts

Jesse Rattan, PhD, MPH, RN

404-606-3319jrattan@uab.edu

Locations

University of Alabama at Birmingham (UAB Women and Infants Center)

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Jesse E Rattan, PhD, MPH, RN

(205)-934-1322jrattan@uab.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Oct 28, 2026

Last verified

Oct, 2026

Keywords

  • Community health worker
  • Postpartum
  • Blood pressure
  • Self-measured blood pressure monitoring
  • Cardiovascular disease prevention
  • Life's Essential 8
  • Hypertensive disorders of pregnancy
  • Alabama
  • Primary care linkage

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-29. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-10-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.