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Heart Health Doulas for Hypertensive Disorders of Pregnancy (HHD Trial)

N/A

Recruiting

Led By Janet Catov, PhD

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months postpartum

Awards & highlights

No Placebo-Only Group

Summary

This trial investigates a multi-level intervention to reduce postpartum blood pressure in women with hypertensive disorder pregnancy. It involves monitoring, weight and a doula trained in heart health.

Who is the study for?

This trial is for pregnant or postpartum women in certain counties of Pennsylvania, diagnosed with hypertensive disorders like pre-eclampsia during the third trimester to two weeks after delivery. They must plan to deliver at Magee-Womens Hospital and not have chronic conditions affecting blood pressure, diabetes, severe kidney/liver disease, or lupus.

What is being tested?

The study compares usual care with a Heart Health Doula Intervention Program that includes home monitoring of blood pressure and weight plus support from a doula trained in heart health. Women are randomly assigned to one of these two approaches to see if the intervention improves postpartum blood pressure control.

What are the potential side effects?

Since this trial involves non-medical interventions such as monitoring and doula support rather than drugs or medical procedures, there are no direct side effects associated with typical clinical trials. However, participants may experience stress or discomfort related to frequent health monitoring.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months postpartum for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assess MAP at 12 months postpartum

Secondary study objectives

Assess Racial Disparities in Healthcare Delivery

Change from baseline in racial disparities and blood pressure & MAP at 12 months

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Postpartum Doula Intervention GroupExperimental Treatment2 Interventions

The intervention group will receive study devices (blood pressure cuff, scales, etc.) and instructions on 10-12 months of remote blood pressure, and weight monitoring. An electronic referral will be sent to the Healthy Start program to initiate postpartum Doula support for 8-12 weeks, and a Doula moderated social support group for 6 months. The postpartum Doula will deliver a heart health focused intervention aimed at reducing blood pressure by approximately 12 weeks postpartum.

Group II: Usual Care GroupActive Control1 Intervention

The usual care group will receive remote blood pressure monitoring for approximately 6 weeks via the clinical home blood pressure monitoring program at Magee Women's Hospital of UPMC and be discharged after delivery as usual. This monitoring is standardly offered to women post-delivery with hypertensive disorders of pregnancy. Participants will text in their blood pressures to the medical record systems and be monitored by clinical staff.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Usual Care

1990

Completed Phase 4

~7700

Do I qualify?Apply below to find out