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Not Yet Recruiting NCT07778966

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

Conditions: Pregnancy-Associated Hypertension, Gestational Hypertension, Preeclampsia, Eclampsia, HELLP Syndrome, Postpartum Hypertension, Stage 2 Hypertension

Sex: Female
Ages: 16 Years – 56 Years
Healthy volunteers: No
Phase: NA
Enrollment: 174
Sponsor: University of Alabama at Birmingham

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

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.

Eligibility Criteria

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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07778966). StuddyBuddy aggregates publicly available trial information.