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

Completed · Not applicable

Conditions studied: Pregnancy

In brief

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

Key facts

Study ID

NCT03504189

Run by

Nuvo-Group, Ltd.

People needed

151

Starts

2018-03-01

Expected to finish

2018-11-08

Last updated by the study team

2020-02-18

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Eastern Virginia Medical School — Norfolk, Virginia, United States
• Heidelberg University Womens Hospital — Heidelberg, Germany
• Hadassah-Hebrew University Medical Center — Jerusalem, Israel

Full record on ClinicalTrials.gov

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