Actively Recruiting
Eliminating Severe Maternal Morbidity With Heart Health Doulas Trial to Improve Postpartum Blood Pressure in Women with Hypertensive Disorders of Pregnancy
Led by University of Pittsburgh · Updated on 2025-10-20
454
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Pittsburgh
Lead Sponsor
N
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a multi-level approach to improve blood pressure in women diagnosed with hypertensive disorders during pregnancy, such as gestational hypertension, preeclampsia, and eclampsia. The study aims to reduce the risk of chronic hypertension, cardiovascular disease, and mortality by supporting new mothers during and after pregnancy. This trial is a single-site, single-blinded randomized control study in partnership with Healthy Start Inc., a community-based organization that supports families and communities. Participants will be randomly assigned to two groups. The usual care group will receive standard home blood pressure monitoring for six weeks after delivery, using clinical devices and text messaging support. The intervention group will receive the usual care plus additional support from a postpartum doula trained in heart health. This includes weekly doula sessions for 8 to 12 weeks, ongoing blood pressure and weight monitoring with smart devices for 10 to 12 months, and access to a doula-moderated social support group for six months. Women enrolled will be monitored from the third trimester through about 12 months postpartum. Assessments include regular blood pressure and weight checks, with data sent via text to clinical staff. Both groups will attend a follow-up visit at 12 months postpartum to assess mean arterial pressure and racial disparities in blood pressure and healthcare delivery. The study includes continuous monitoring and support to understand how these interventions may affect postpartum blood pressure and health outcomes.
CONDITIONS
Brief Title
Eliminating Severe Maternal Morbidity With Heart Health Doulas Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women must be pregnant or postpartum and diagnosed with a hypertensive disorder of pregnancy (pre-eclampsia, eclampsia, or gestational hypertension).
- Women must live in Allegheny, Westmoreland, Beaver, Butler, or Washington County, or within 100 miles of Allegheny County.
- Participants must deliver or plan to deliver at Magee-Womens Hospital.
- Women must be 18 years or older.
You will not qualify if you...
- History of pre-pregnancy chronic conditions affecting blood pressure, including hypertension or use of antihypertensive medications within 3 months before conception.
- Diagnosis of diabetes (type 1 or type 2).
- Chronic and severe kidney or liver disease, or systemic lupus erythematous.
- Women under 18 years old.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or virtual) during third trimester up to a few weeks postpartum
Duration - Up to 12 months postpartum
Participants receive either usual care involving 6 weeks of home-based blood pressure monitoring with text messaging support, or the Heart Health Doula Intervention Program involving weekly doula sessions for 8-12 weeks and continued blood pressure and weight monitoring for up to 12 months postpartum.
Weekly check-ins with doula for 8-12 weeks (intervention group) and 6-week home blood pressure monitoring program (both groups)
Duration - At 12 months postpartum
Participants attend a follow-up visit at 12 months postpartum to assess blood pressure and overall health.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Magee Women's Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
J
Janet Catov, PhD
E
Esa Davis, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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