A clinical study designed to validate the safety and performance of the TrueLabor™ device in monitoring labor vs. current standard of care.
Study Type
OBSERVATIONAL
Enrollment
80
Non invasive monitoring device
Ascension Illinois Saint Alexius Residency Program in Obstetrics and Gynecology
Hoffman Estates, Illinois, United States
Montefiore Medical Center
The Bronx, New York, United States
Meir Medical Center
Kfar Saba, Israel
Safety, comparative performance, and reliability of the TrueLabor™ system for Fetal Heart Rate
This will be performed using a Performance Goal
Time frame: Through labor, until delivery
Safety, comparative performance, and reliability of the TrueLabor™ system for Uterine Activity
This will be performed using a Performance Goal
Time frame: Through labor, until delivery
Effect of BMI (weight in Kg, height in meters will be combined to report BMI in kg/m2)
Effect of BMI on the performance measures
Time frame: Through labor, until delivery
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