RecruitingNot ApplicableNCT05655936

Eliminating Severe Maternal Morbidity With Heart Health Doulas Trial

Sponsor

University of Pittsburgh

Enrollment

454 participants

Start Date

Jun 29, 2023

Study Type

INTERVENTIONAL

Conditions

Pregnancy Complications Preeclampsia Hypertensive Disorder of Pregnancy Toxemia

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a heart health doula program — a trained community health worker who provides ongoing support and education — can reduce serious health complications in pregnant or recently pregnant women who have high blood pressure disorders (like preeclampsia). **You may be eligible if...** - You are pregnant or recently gave birth - You were diagnosed during pregnancy or delivery with a hypertensive disorder such as preeclampsia, eclampsia, or gestational hypertension - You live in or near Allegheny County, Pennsylvania (within 100 miles) - You delivered or plan to deliver at Magee-Womens Hospital - You are 18 or older **You may NOT be eligible if...** - You had high blood pressure before pregnancy, or were on blood pressure medications within 3 months before conception - You have diabetes (type 1 or type 2) - You have chronic kidney disease, liver disease, or lupus - You are under 18 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALHeart Health Doula Intervention Program

The intervention group will be given a smart blood pressure cuff and a smart scale to monitor weight. The intervention group will receive support provided a postpartum doula until 8-12 weeks postpartum. The doula will provide individualized support during this time, and after 8-12 weeks, women will transition to a doula-moderated support group for the remainder of the study. The intervention group will continue to receive blood pressure and weight monitoring for the remainder of the study.

BEHAVIORALUsual Care

Usual care includes enrollment into a clinical 6-week home-based blood pressure monitoring program with text messaging support which includes receiving a home blood pressure cuff. Women in the intervention group will be offered the same support as the usual care group, and in addition will receive the intervention and supplies.