Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT05655936

Eliminating Severe Maternal Morbidity With Heart Health Doulas Trial

Led by University of Pittsburgh · Updated on 2025-10-20

454

Participants Needed

1

Research Sites

209 weeks

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

This is a single site, single-blinded parallel randomized control trial that investigates a multi-level intervention to improve postpartum blood pressure in women with hypertensive disorder pregnancy. The investigators will recruit women diagnosed with a hypertensive disorder of pregnancy, identified between 3rd trimester and 2 weeks post-delivery. The investigators will randomize participants to receive usual care home blood pressure monitoring for 6 weeks versus an intervention of usual care + blood pressure and weight monitoring + a doula trained in heart health. This trial will be conducted in partnership with a local community-based organization, Healthy Start Inc.

CONDITIONS

Official Title

Eliminating Severe Maternal Morbidity With Heart Health Doulas Trial

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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.
Not Eligible

You will not qualify if you...

  • Women with pre-pregnancy chronic conditions affecting blood pressure such as hypertension or on antihypertensive medications within 3 months before conception.
  • Women with type 1 or type 2 diabetes.
  • Women with chronic and severe renal or liver disease or systemic lupus erythematous.
  • Women under 18 years old.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Magee Women's Hospital of UPMC

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

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Research Team

J

Janet Catov, PhD

CONTACT

E

Esa Davis, MD

CONTACT

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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