No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
16 – 56
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
174 (estimated)
Sponsor
University of Alabama at Birmingham · Other
Who this trial is looking for
This trial is looking for women who had high blood pressure during or after pregnancy. Participants will get support from a community health worker for 6 months to help manage their blood pressure.
Are You a Good Fit for This Trial?
You may be able to join if
I had high blood pressure during or after my pregnancy.
I delivered in the last six weeks.
I am between 16 and 56 years old.
I speak and write in English.
I delivered at the University of Alabama at Birmingham Hospital.
You may not be able to join if
I do not want to participate in a random study.
I do not speak English.
I am currently in jail.
I am already part of another community health worker study.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 wil…
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.
Trial Locations
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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 Col…
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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