NCT05655936 Eliminating Severe Maternal Morbidity With Heart Health Doulas Trial
| NCT ID | NCT05655936 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pittsburgh |
| Condition | Preeclampsia |
| Study Type | INTERVENTIONAL |
| Enrollment | 454 participants |
| Start Date | 2023-06-29 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 454 participants in total. It began in 2023-06-29 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Janet Catov, PhD
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT05655936 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Preeclampsia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05655936 currently recruiting?
Yes, NCT05655936 is actively recruiting participants. Contact the research team at catovjm@mwri.magee.edu for enrollment information.
Where is the NCT05655936 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT05655936 clinical trial?
NCT05655936 is sponsored by University of Pittsburgh. The principal investigator is Janet Catov, PhD at University of Pittsburgh. The trial plans to enroll 454 participants.