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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03504189
Recruitment Status : Completed
First Posted : April 20, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pregnancy Device: PregSense™ Device: Cardiotocopraphy (CTG) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open Label
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Clinical Study Evaluating the Safety of PregSense and Comparative Performance of PregSense Versus CTG in Prenatal Monitoring of Pregnant Subjects
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : June 27, 2018
Actual Study Completion Date : November 8, 2018

Arm Intervention/treatment
Experimental: PregSense™
PregSense™ wearable device and the standard of care CTG (cardiotocography) will be applied for maternal-fetal monitoring
Device: PregSense™
PregSense™ wearable device will be applied for maternal-fetal monitoring

Device: Cardiotocopraphy (CTG)
Cardiotocopraphy (CTG) will be applied for maternal-fetal monitoring




Primary Outcome Measures :
  1. Fetal Heart Rate [ Time Frame: 30 Minutes ]
    Compare fetal heart rate data from PregSense™ versus CTG.

  2. Maternal Heart Rate [ Time Frame: 30 MInutes ]
    Compare maternal heart rate data from PregSense™ versus CTG.


Secondary Outcome Measures :
  1. Uterine Contractions [ Time Frame: 30 Minutes ]
    Compare uterine contractions from Pregsense™ versus CTG.


Other Outcome Measures:
  1. Safety Measures [ Time Frame: Through study completion, an average of 1 hour ]
    Evaluate device related adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant females
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504189


Locations
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United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Virginia
Eastern Virginia Medical School
Norfolk, Virginia, United States, 23507
Germany
Heidelberg University Womens Hospital
Heidelberg, Germany
Israel
Hadassah-Hebrew University Medical Center
Jerusalem, Israel
Sponsors and Collaborators
Nuvo-Group, Ltd.

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Responsible Party: Nuvo-Group, Ltd.
ClinicalTrials.gov Identifier: NCT03504189     History of Changes
Other Study ID Numbers: CLP1000
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Nuvo-Group, Ltd.:
Fetal monitoring, Prenatal monitoring