NCT05655936

Eliminating Severe Maternal Morbidity With Heart Health Doulas Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 454 (estimated)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The purpose of this study is to improve blood pressure in women who have a hypertensive disorder of pregnancy. A hypertensive disorder of pregnancy is one in which a woman's blood pressure is elevated during pregnancy. For the purpose of this project, a hypertensive disorder of pregnancy includes gestational hypertension, preeclampsia and eclampsia. By improving blood pressure in pregnant women, the investigators aim to lower the number of women with chronic hypertension, cardiovascular disease, and mortality. The study will enroll 454 women who are 18 years or older, are about to or have recently given birth, and have been diagnosed with a hypertensive disorder of pregnancy. Women will be randomly chosen to take part in usual care or an intervention group. This study is designed to evaluate support for new moms by providing a postpartum doula in partnership with Healthy Start Inc. Healthy Start is a local community-based organization that supports women, children, fathers, families and communities through community-based programming, advocacy, research, and training. The support provided to new moms will include weekly doula sessions (in-person or virtual), education and support, and blood pressure and weight monitoring. Women will be enrolled during their third trimester up until they are a few weeks postpartum and will complete the study around 12 months postpartum. If assigned to the intervention group, women will attend weekly check-ins with their doula for 8-12 weeks and receive continuous blood pressure and weight monitoring throughout the duration of the study. Both groups will be enrolled into a 6-week home-based blood pressure monitoring program with text messaging support (enrollment in the 6-week program is the standard of care at Magee Women's Hospital following a hypertensive disorder of pregnancy). Both the usual care and intervention groups will attend a follow-up visit at 12 months postpartum.

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

Type	Name	Description
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.

Timeline

• Start date: 2023-06-29
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2022-12-19
• Last updated: 2025-10-20

Locations

1 site across 1 country: United States