Eliminating Severe Maternal Morbidity With Heart Health Doulas Trial

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.

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

Interventions

BEHAVIORAL

Heart 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.

BEHAVIORAL

Usual 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.

Sponsors & Collaborators

• National Institute on Minority Health and Health Disparities (NIMHD)

  collaborator NIH

• University of Pittsburgh

  lead OTHER

Principal Investigators

• Janet Catov, PhD · University of Pittsburgh

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-06-29

Primary Completion

2027-07-01

Completion

2027-07-01

Countries

• United States

Study Locations