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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03504189
• Other study ID #: CLP1000
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: November 8, 2018

Study information

• Verified date: February 2020
• Source: Nuvo-Group, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: November 8, 2018
• Est. primary completion date: June 27, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy

Intervention

Device:
• PregSense™
PregSense™ wearable device will be applied for maternal-fetal monitoring
• Cardiotocopraphy (CTG)
Cardiotocopraphy (CTG) will be applied for maternal-fetal monitoring

Locations

Country	Name	City	State
Germany	Heidelberg University Womens Hospital	Heidelberg
Israel	Hadassah-Hebrew University Medical Center	Jerusalem
United States	Eastern Virginia Medical School	Norfolk	Virginia
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Nuvo-Group, Ltd.

Countries where clinical trial is conducted

United States,  Germany,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety Measures	Evaluate device related adverse events	Through study completion, an average of 1 hour
Primary	Fetal Heart Rate	Provide evidence of safety and FHR agreement between PregSense™ and the standard of care devices (i.e. CTG)	30 Minutes
Primary	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	Uterine Contractions	Compare uterine contractions from Pregsense™ versus CTG.	30 Minutes