The objective of this study is to demonstrate the safety and performance of the M•care™ System for use in antenatal monitoring of pregnant women ≥ 32 weeks' gestation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
120
The M•care™ System will be applied for monitoring of fetal heart rate (FHR), maternal heart rate (MHR) and uterine activity (UA)
A standard of care CTG device will be applied for monitoring of fetal heart rate (FHR), maternal heart rate (MHR) and uterine activity (UA)
NorthShore University Health System
Evanston, Illinois, United States
Fetal Heart Rate (FHR)
FHR as measured by the M•care System versus standard of care CTG device
Time frame: Up to 120 minutes
Maternal Heart Rate (MHR)
MHR as measured by the M•care System versus standard of care CTG device
Time frame: Up to 120 minutes
Uterine Contractions (UC)
UC sensitivity as measured by the M•care System versus standard of care CTG device, where sensitivity is defined as the proportion of UC events identified by standard of care that are simultaneously identified by the M•care System (positive agreement).
Time frame: Up to 120 minutes
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