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



Status:Completed
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - 50
Updated:11/16/2018
Start Date:March 1, 2018
End Date:November 8, 2018

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

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

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.

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
We found this trial at
3
sites
3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Principal Investigator: Nadav Schwartz, M.D.
Phone: 215-615-4358
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Philadelphia, PA
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Norfolk, Virginia 23507
Principal Investigator: Steven Warsof, M.D.
Phone: 757-624-2241
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Norfolk, VA
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Heidelberg,
Principal Investigator: Marin Jacobs, MD
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Heidelberg,
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