Clinical trial NCT05655936: Eliminating Severe Maternal Morbidity With Heart Health Doulas Trial
Official title: Eliminating Severe Maternal Morbidity With Heart Health Doulas Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Keywords: Postpartum Doula, Doula Intervention
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2022-12-19
Enrollment: 454
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators will conduct a prospective single site, single-blinded, parallel randomized control trial in which women diagnosed with HDP will be randomized into either the control or intervention group. The investigators will randomize 454 women into usual care, or an 8-12-week heart health intervention program provided by a postpartum Doula. Randomization will be stratified by race to achieve over enrollment of Black and African American participants.
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Assess MAP at 12 months postpartum
timeFrame: Baseline to approximately 12 months postpartum
Secondary outcomes:
measure: Change from baseline in racial disparities and blood pressure & MAP at 12 months
timeFrame: Baseline to approximately 12 months postpartum
measure: Assess Racial Disparities in Healthcare Delivery
timeFrame: Up to 12 months postpartum
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Magee Women's Hospital of UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Janet Catov, PhD
role: PRINCIPAL_INVESTIGATOR
References: