Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.

Tracking Information
First Submitted Date  ICMJE March 5, 2018
First Posted Date  ICMJE April 20, 2018
Last Update Posted Date November 14, 2018
Actual Study Start Date  ICMJE March 1, 2018
Actual Primary Completion Date June 27, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2018)
  • Fetal Heart Rate [ Time Frame: 30 Minutes ]
    Compare fetal heart rate data from PregSense™ versus CTG.
  • Maternal Heart Rate [ Time Frame: 30 MInutes ]
    Compare maternal heart rate data from PregSense™ versus CTG.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03504189 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2018)
Uterine Contractions [ Time Frame: 30 Minutes ]
Compare uterine contractions from Pregsense™ versus CTG.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 19, 2018)
Safety Measures [ Time Frame: Through study completion, an average of 1 hour ]
Evaluate device related adverse events
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Evaluating the Safety of PregSense™ and Compare Its Performance to CTG in Prenatal Monitoring of Pregnant Subjects
Official Title  ICMJE Clinical Study Evaluating the Safety of PregSense and Comparative Performance of PregSense Versus CTG in Prenatal Monitoring of Pregnant Subjects
Brief Summary This clinical study will evaluate the safety of PregSense™ and Comparative Performance of PregSense™ versus CTG in Prenatal Monitoring of Pregnant subjects.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Open Label
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Pregnancy
Intervention  ICMJE
  • Device: PregSense™
    PregSense™ wearable device will be applied for maternal-fetal monitoring
  • Device: Cardiotocopraphy (CTG)
    Cardiotocopraphy (CTG) will be applied for maternal-fetal monitoring
Study Arms  ICMJE Experimental: PregSense™
PregSense™ wearable device and the standard of care CTG (cardiotocography) will be applied for maternal-fetal monitoring
Interventions:
  • Device: PregSense™
  • Device: Cardiotocopraphy (CTG)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 11, 2018)
151
Original Estimated Enrollment  ICMJE
 (submitted: April 19, 2018)
200
Actual Study Completion Date  ICMJE November 8, 2018
Actual Primary Completion Date June 27, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Pregnant females
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Israel,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03504189
Other Study ID Numbers  ICMJE CLP1000
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Nuvo-Group, Ltd.
Study Sponsor  ICMJE Nuvo-Group, Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Nuvo-Group, Ltd.
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP