Evaluating the Safety of PregSense™ and Compare Its Performance to CTG in Prenatal Monitoring of Pregnant Subjects

Clinical Study Evaluating the Safety of PregSense and Comparative Performance of PregSense Versus CTG in Prenatal Monitoring of Pregnant Subjects

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.

Inclusion Criteria:

• Female age between 18-50
• Gestational age > 32 + 0 weeks
• Singleton gestation
• Ability to understand and sign informed consent

Exclusion Criteria:

• BMI (Body Mass Index) ≥ 45 and ≤15 prior pregnancy
• Multiple gestation
• Uncontrolled Hypertension
• Fetal Anomaly
• Subjects with skin problems in the abdominal area (such as flesh wounds, cuts in the skin, skin rashes, etc.)
• Subjects with implanted electronic devices (pacemaker, defibrillator, etc.)
• Subjects who, in the judgement of the investigator, are likely to be non-compliant or uncooperative during the study