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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03504189
Other study ID # CLP1000
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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