Eliminating Severe Maternal Morbidity With Heart Health Doulas Trial (HHD)

University of Pittsburgh

Status: Enrolling

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

Treatments: Behavioral: Usual Care; Behavioral: Heart Health Doula Intervention Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05655936

STUDY22060056

1R01MD017083-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 454 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

454 participants in 2 patient groups

Usual Care Group

Active Comparator group

Description:

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:

Behavioral: Usual Care

Postpartum Doula Intervention Group

Experimental group

Description:

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.

Treatment:

Behavioral: Heart Health Doula Intervention Program

Behavioral: Usual Care