Status:
ACTIVE_NOT_RECRUITING
Wireless Physiologic Monitoring in Postpartum Women
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Mbarara University of Science and Technology
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Maternal Death During Childbirth
Pregnancy Complications
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To estimate the clinical effectiveness of wireless physiologic monitoring of women in the first 24 hours after cesarean delivery at Mbarara Regional Referral Hospital
Detailed Description
Women in sub-Saharan Africa have the highest rates of morbidity and mortality during childbirth. Despite significant increases in facility-based childbirth, quality gaps at the facility have limited r...
Eligibility Criteria
Inclusion
- Emergency cesarean delivery at MRRH
- Able to provide consent or have a guardian/attendant present who can consent
- Willing to wear the biosensor for 24 hours
- Willing remain in the postpartum unit for 24 hours
Exclusion
- Admitted to ICU directly after delivery
- Allergies or hypersensitivity to device materials
Key Trial Info
Start Date :
January 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
3191 Patients enrolled
Trial Details
Trial ID
NCT04060667
Start Date
January 21 2020
End Date
December 31 2025
Last Update
September 9 2025
Active Locations (1)
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1
Mbarara Regional Referral Hospital
Mbarara, Uganda