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.
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
Declines randomization
Does not speak English
Currently incarcerated
Currently enrolled in other community health worker studies or services
Parallel
Alabama Womb to Heart Solution (AW2H) Community Health Worker (CHW) Program
BehavioralSix-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
Other interventionStandardized 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.
Systolic Blood Pressure (SBP)
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.
Diastolic Blood Pressure (DBP)
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.
Scheduling of a Primary Care Visit
Proportion of participants with integration into primary care, defined as participant self-report of a scheduled primary care visit.
Mean Arterial Blood Pressure (MAP)
Mean arterial blood pressure in mmHg, derived from blood pressure readings taken using the same standardized protocol as the primary outcome.
Click on the lead sponsor to view all of their trials.
University of Alabama at Birmingham
Lead sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
ConnectionHealth
Collaborator
Preeclampsia Foundation
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
