This clinical study will evaluate the safety of PregSense™ and Comparative Performance of PregSense™ versus CTG in Prenatal Monitoring of Pregnant subjects.
PregSense™ is a maternal-fetal monitor that non-invasively measures and displays fetal heart rate, maternal hear rate and uterine contractions. This study will be performed to collect and digitally record data from PregSense™ and the standard of care (CTG) in order to provide evidence of safety and agreement between PregSense™ and the gold standard NST device.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
151
PregSense™ wearable device will be applied for maternal-fetal monitoring
Cardiotocopraphy (CTG) will be applied for maternal-fetal monitoring
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States
Heidelberg University Womens Hospital
Heidelberg, Germany
Hadassah-Hebrew University Medical Center
Jerusalem, Israel
Fetal Heart Rate
Provide evidence of safety and FHR agreement between PregSense™ and the standard of care devices (i.e. CTG)
Time frame: 30 Minutes
Maternal Heart Rate
Provide evidence of safety and agreement between MHR collected via the PregSense™ and the standard of care devices (i.e. CTG)
Time frame: 30 MInutes
Uterine Contractions
Compare uterine contractions from Pregsense™ versus CTG.
Time frame: 30 Minutes
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