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

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ClinicalTrials.gov Identifier: NCT03504189
Recruitment Status : Completed
First Posted : April 20, 2018
Results First Posted : February 18, 2020
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
Nuvo-Group, Ltd.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Pregnancy
Interventions Device: PregSense™
Device: Cardiotocopraphy (CTG)
Enrollment 151
Recruitment Details  
Pre-assignment Details  
Arm/Group Title "PregSense™ and Cardiotocopraphy (CTG)"
Hide Arm/Group Description

PregSense™ WSB then was applied by the authorized study personnel to the maternal abdominal area, not before cleaning the maternal abdomen with a damp cloth, then drying the abdomen. Before initiating the recording session, a valid signal is to be obtained.

An authorized study personnel applied the CTG transducers and confirmed fetal heart rate detection according to the standard of care procedure.

If a valid signal was detected, a 30-minute session initiated, recording both systems simultaneously in a synchronized method (PregSense™ and CTG).

Following the completion of the sessions, the authorized study personnel removed both monitoring systems from the maternal abdomen.

Period Title: Overall Study
Started 151
Completed 147
Not Completed 4
Reason Not Completed
Withdrawal by Subject             1
Screening Failure             1
Device Failure             2
Arm/Group Title PregSense™
Hide Arm/Group Description

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

Overall Number of Baseline Participants 147
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants
<=18 years 0
Between 18 and 65 years 147
>=65 years 0
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 147 participants
31.8  (6.89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants
Female
147
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants
Hispanic or Latino
3
   2.0%
Not Hispanic or Latino
140
  95.2%
Unknown or Not Reported
4
   2.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants
United States 69
Israel 49
Germany 31
1.Primary Outcome
Title Fetal Heart Rate
Hide Description Provide evidence of safety and FHR agreement between PregSense™ and the standard of care devices (i.e. CTG)
Time Frame 30 Minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title "PregSense™ and Cardiotocopraphy (CTG)" Cardiotocopraphy (CTG)
Hide Arm/Group Description:
PregSense™ wearable device was applied for maternal-fetal monitoring
Philips FM30 (CTG) was applied for maternal-fetal monitoring
Overall Number of Participants Analyzed 147 147
Mean (Standard Deviation)
Unit of Measure: bpm
140.3  (11.9) 140.4  (11.65)
2.Primary Outcome
Title Maternal Heart Rate
Hide Description Provide evidence of safety and agreement between MHR collected via the PregSense™ and the standard of care devices (i.e. CTG)
Time Frame 30 MInutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PregSense™ Cardiotocopraphy (CTG)
Hide Arm/Group Description:
PregSense™ wearable device was applied for maternal-fetal monitoring
Philips FM30 Cardiotocopraphy (CTG) was applied for maternal-fetal monitoring
Overall Number of Participants Analyzed 147 147
Mean (Standard Deviation)
Unit of Measure: bpm
89.3  (12.54) 89.1  (12.5)
3.Secondary Outcome
Title Uterine Contractions
Hide Description Compare uterine contractions from Pregsense™ versus CTG.
Time Frame 30 Minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Uterine Contraction information was eventually not collected AT ALL, therefore no population to describe.
Arm/Group Title "PregSense™ and Cardiotocopraphy (CTG)"
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Other Pre-specified Outcome
Title Safety Measures
Hide Description Evaluate device related adverse events
Time Frame Through study completion, an average of 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PregSense™
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 147
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
Time Frame 30 minutes during Non stress test (NST)
Adverse Event Reporting Description No adverse events reported during the trial
 
Arm/Group Title PregSense™
Hide Arm/Group Description

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

All-Cause Mortality
PregSense™
Affected / at Risk (%)
Total   0/147 (0.00%) 
Hide Serious Adverse Events
PregSense™
Affected / at Risk (%)
Total   0/147 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PregSense™
Affected / at Risk (%)
Total   0/147 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: VP Clinical
Organization: Nuvo Group
Phone: +972-3-6242266 ext 1630
EMail: adar.shani@nuvocares.com
Layout table for additonal information
Responsible Party: Nuvo-Group, Ltd.
ClinicalTrials.gov Identifier: NCT03504189    
Other Study ID Numbers: CLP1000
First Submitted: March 5, 2018
First Posted: April 20, 2018
Results First Submitted: January 13, 2019
Results First Posted: February 18, 2020
Last Update Posted: February 18, 2020