Status:
NOT_YET_RECRUITING
Mindfulness and Wearable Biosensors to Prevent Hypertensive Disorders of Pregnancy
Lead Sponsor:
Medical College of Wisconsin
Conditions:
Preeclampsia
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The MINDBP study will enroll 90 pregnant women at risk for HDP across two sites (MCW and Brown) and randomize them to: (1) mindfulness training (MT) plus wearable biosensors, (2) MT alone, or (3) rout...
Detailed Description
The MINDBP study will enroll 90 pregnant women at risk for HDP across two sites (MCW and Brown) and randomize them to: (1) MT + wearable biosensors, (2) MT alone, or (3) routine prenatal care. MT part...
Eligibility Criteria
Inclusion
- Pregnant patients at gestational age \<= 16 weeks
- Live, non-anomalous gestation
- Normotensive at enrollment
- Meet criteria consistent with 'moderate' to 'high' risk for preeclampsia based on ACOG/USPSTF guidelines for low-dose aspirin administration to prevent hypertensive disorders of pregnancy
Exclusion
- Multiple gestation
- Chronic (pregestational hypertension)
- Inability of unwillingness to provide informed consent
- Active suicidality or psychosis
- Ongoing mind-body practice (e.g., yoga, meditation, mindfulness \>= once per week)
Key Trial Info
Start Date :
March 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT07218237
Start Date
March 1 2026
End Date
October 1 2028
Last Update
October 17 2025
Active Locations (2)
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1
Brown University
Providence, Rhode Island, United States, 02904
2
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226