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

Not Applicable

Completed

• Conditions: Pregnancy
• Interventions: Device: PregSense™; Device: Cardiotocopraphy (CTG)

• Registration Number: NCT03504189
• Lead Sponsor: Nuvo-Group, Ltd.

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2018-03-01
• Study First Submitted: 2018-03-05
• Study First Submitted QC: 2018-04-19
• Study First Posted: 2018-04-20
• Primary Completion: 2018-06-27
• Study Completion: 2018-11-08
• Results First Submitted: 2019-01-13
• Status Verified: 2020-02
• Results First Submitted QC: 2020-02-06
• Last Update Submitted: 2020-02-06
• Results First Posted: 2020-02-18
• Last Update Posted: 2020-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 151

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PregSense™	PregSense™	PregSense™ wearable device and the standard of care CTG (cardiotocography) will be applied for maternal-fetal monitoring
PregSense™	Cardiotocopraphy (CTG)	PregSense™ wearable device and the standard of care CTG (cardiotocography) will be applied for maternal-fetal monitoring

Primary Outcome Measures

Name	Time	Method
Maternal Heart Rate	30 MInutes	Provide evidence of safety and agreement between MHR collected via the PregSense™ and the standard of care devices (i.e. CTG)
Fetal Heart Rate	30 Minutes	Provide evidence of safety and FHR agreement between PregSense™ and the standard of care devices (i.e. CTG)

Secondary Outcome Measures

Name	Time	Method
Uterine Contractions	30 Minutes	Compare uterine contractions from Pregsense™ versus CTG.

Trial Locations

Locations (4)

Hadassah-Hebrew University Medical Center; 🇮🇱 Jerusalem, Israel

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Heidelberg University Womens Hospital; 🇩🇪 Heidelberg, Germany

Eastern Virginia Medical School; 🇺🇸 Norfolk, Virginia, United States