Eliminating Severe Maternal Morbidity With Heart Health Doulas Trial

RECRUITING

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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:

🦠 Preeclampsia 🦠 Hypertensive Disorder of Pregnancy 🦠 Toxemia 🦠 Pregnancy Complications 🦠 Hypertension, Pregnancy-Induced 🦠 Hypertension 🦠 Obesity 🦠 Overweight 🦠 Nutrition Disorders 🦠 Vascular Diseases 🦠 Cardiovascular Diseases 🦠 Pre-Eclampsia 🦠 Eclampsia 🦠 Gestational Hypertension

More conditions available...

🗓️ Study Start (Actual) 29 June 2023

🗓️ Primary Completion (Estimated) 1 July 2027

✅ Study Completion (Estimated) 1 July 2027

👥 Enrollment (Estimated) 454

🔬 Study Type INTERVENTIONAL

📊 Phase NA

Locations:

📍 Pittsburgh, Pennsylvania, United States

📋 Eligibility Criteria

Description

Inclusion
* Women must be pregnant or postpartum and assessed during pregnancy and/or delivery with a diagnosis of a hypertensive disorder of pregnancy (pre-eclampsia, eclampsia or gestational hypertension).
* Women must reside in Allegheny, Westmoreland, Beaver, Butler, or Washington County. Participant may also reside within 100 miles of Allegheny County.
* The participant must deliver (or plan to deliver) at Magee-Womens Hospital
Exclusion
* No pre-pregnancy chronic conditions that affect blood pressure such as hypertension or on antihypertensive medications within 3 months before conception.
* No diabetes (type 1 or type 2)
* No chronic and severe renal or liver disease or systemic lupus erythematous
* No women under the age of 18

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: FEMALE

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 8 December 2022
First Submitted that Met QC Criteria 15 December 2022
First Posted 19 December 2022

Study Record Updates