Evaluating the Safety of PregSense™ and Compare Its Performance to CTG in Prenatal Monitoring of Pregnant Subjects
NCT ID: NCT03504189
Last Updated: 2020-02-18
Study Results
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View full resultsBasic Information
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COMPLETED
NA
151 participants
INTERVENTIONAL
2018-03-01
2018-11-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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PregSense™
PregSense™ wearable device and the standard of care CTG (cardiotocography) will be applied for maternal-fetal monitoring
PregSense™
PregSense™ wearable device will be applied for maternal-fetal monitoring
Cardiotocopraphy (CTG)
Cardiotocopraphy (CTG) will be applied for maternal-fetal monitoring
Interventions
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PregSense™
PregSense™ wearable device will be applied for maternal-fetal monitoring
Cardiotocopraphy (CTG)
Cardiotocopraphy (CTG) will be applied for maternal-fetal monitoring
Eligibility Criteria
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Inclusion Criteria
* Gestational age \> 32 + 0 weeks
* Singleton gestation
* Ability to understand and sign informed consent
Exclusion Criteria
* 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
18 Years
50 Years
FEMALE
No
Sponsors
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Nuvo-Group, Ltd.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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References
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Mhajna M, Schwartz N, Levit-Rosen L, Warsof S, Lipschuetz M, Jakobs M, Rychik J, Sohn C, Yagel S. Wireless, remote solution for home fetal and maternal heart rate monitoring. Am J Obstet Gynecol MFM. 2020 May;2(2):100101. doi: 10.1016/j.ajogmf.2020.100101. Epub 2020 Mar 17.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CLP1000
Identifier Type: -
Identifier Source: org_study_id
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