Eliminating Severe Maternal Morbidity With Heart Health Doulas Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Pennsylvania
Magee Women's Hospital of UPMC
RECRUITING
Pittsburgh
Contact Information
Primary
Janet Catov, PhD
catovjm@mwri.magee.edu
412-641-6217
Backup
Esa Davis, MD
Esa.Davis@som.umaryland.edu
410-706-4116
Time Frame
Start Date: 2023-06-29
Estimated Completion Date: 2027-07-01
Participants
Target number of participants: 454
Treatments
Active_comparator: Usual Care Group
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.
Experimental: Postpartum Doula Intervention Group
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.
Sponsors
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
Leads: University of Pittsburgh

This content was sourced from clinicaltrials.gov

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