A Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for Antepartum Fetal Monitoring

NACompletedINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

June 25, 2021

Primary Completion Date

November 9, 2021

Study Completion Date

November 25, 2021

Conditions
Fetal Monitoring
Interventions
DEVICE

Bloomlife MFM-Pro

"Bloomlife MFM-Pro is a non-invasive, wireless, external monitoring system used to measure fetal heart rate, maternal heart rate, and uterine activity during antepartum (non-stress) testing on pregnant women with a singleton pregnancy.~The system acquires biopotential signals from abdominal surface electrodes and measures the fetal electrocardiography, maternal electrocardiography, electrohysterography, as well as accelerometer data."

Trial Locations (1)

3600

Ziekenhuis Oost-Limburg, Genk

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bloom Technologies

INDUSTRY

NCT05060172 - A Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for Antepartum Fetal Monitoring | Biotech Hunter | Biotech Hunter