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

Study Overview
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Brief Summary
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This clinical study will evaluate the safety of PregSense™ and Comparative Performance of PregSense™ versus CTG in Prenatal Monitoring of Pregnant subjects.

Detailed Description
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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.

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

Conditions
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Pregnancy

Intervention / Treatment
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* Device: PregSense™
* Device: Cardiotocopraphy (CTG)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Open Label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PregSense™<br>PregSense™ wearable device and the standard of care CTG (cardiotocography) will be applied for maternal-fetal monitoring | Device: PregSense™<br>* PregSense™ wearable device will be applied for maternal-fetal monitoring<br>Device: Cardiotocopraphy (CTG)<br>* Cardiotocopraphy (CTG) will be applied for maternal-fetal monitoring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fetal Heart Rate | Provide evidence of safety and FHR agreement between PregSense™ and the standard of care devices (i.e. CTG) | 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) | 30 MInutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uterine Contractions | Compare uterine contractions from Pregsense™ versus CTG. | 30 Minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fetal monitoring, Prenatal monitoring