Eliminating Severe Maternal Morbidity With Heart Health Doulas Trial (NCT05655936) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Eliminating Severe Maternal Morbidity With Heart Health Doulas Trial
United States454 participantsStarted 2023-06-29
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assess MAP at 12 months postpartum
Timeframe: Baseline to approximately 12 months postpartum