← Back to all trials
Active Not Recruiting
NCT05655936
Eliminating Severe Maternal Morbidity With Heart Health Doulas Trial
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
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 454
Sponsor: University of Pittsburgh
Location: Magee Women's Hospital of UPMC Pittsburgh Pennsylvania
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 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
Source: ClinicalTrials.gov (NCT05655936). StuddyBuddy aggregates publicly available trial information.