NCT05655936Active, not recruiting
Eliminating Severe Maternal Morbidity With Heart Health Doulas Trial
Source: ClinicalTrials.gov · Last updated 6 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 454 (estimated)
- First submitted
- 8 Dec 2022
- Start date
- 29 Jun 2023
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- University of Pittsburgh
- Diseases
- Obesity, High blood pressure
- NCT number
- NCT05655936
What you commit to
- Study type: Interventional
- Planned participants: 454
- From 29 Jun 2023 to the primary completion date, 31 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Magee Women's Hospital of UPMC Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.