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

• Sponsor: Nuvo-Group, Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03504189
• Collaborator: (none)
• Enrollment: 151
• Locations: 4
• Arm: 1
• Actual Duration (Months): 8.3
• Patients Per Site: 37.8
• Patients Per Site Per Month: 4.6

Study Details

Study Description

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)	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 151 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Open LabelOpen 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: Mar 1, 2018
• Actual Primary Completion Date: Jun 27, 2018
• Actual Study Completion Date: Nov 8, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Fetal Heart Rate [30 Minutes]

   Provide evidence of safety and FHR agreement between PregSense™ and the standard of care devices (i.e. CTG)

2. Maternal Heart Rate [30 MInutes]

   Provide evidence of safety and agreement between MHR collected via the PregSense™ and the standard of care devices (i.e. CTG)

Secondary Outcome Measures

1. Uterine Contractions [30 Minutes]

   Compare uterine contractions from Pregsense™ versus CTG.

Other Outcome Measures

1. Safety Measures [Through study completion, an average of 1 hour]

   Evaluate device related adverse events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
2	Eastern Virginia Medical School	Norfolk	Virginia	United States	23507
3	Heidelberg University Womens Hospital	Heidelberg		Germany
4	Hadassah-Hebrew University Medical Center	Jerusalem		Israel

Sponsors and Collaborators

• Nuvo-Group, Ltd.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 14, 2018

More Information

Publications

None provided.

• Responsible Party: Nuvo-Group, Ltd.
• ClinicalTrials.gov Identifier: NCT03504189
• Other Study ID Numbers: CLP1000
• First Posted: Apr 20, 2018
• Last Update Posted: Feb 18, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Nuvo-Group, Ltd.: Fetal monitoring, Prenatal monitoring

Study Results

Participant Flow

Arm/Group Title	"PregSense™ and Cardiotocopraphy (CTG)"
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

Baseline Characteristics

Arm/Group Title	PregSense™
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 Participants	147
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	147 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.8 (6.89)
Sex: Female, Male (Count of Participants)
Female	147 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 2%
Not Hispanic or Latino	140 95.2%
Unknown or Not Reported	4 2.7%
Region of Enrollment (Count of Participants)
United States	69 46.9%
Israel	49 33.3%
Germany	31 21.1%

Outcome Measures

1. Primary Outcome

Title	Fetal Heart Rate
Description	Provide evidence of safety and FHR agreement between PregSense™ and the standard of care devices (i.e. CTG)
Time Frame	30 Minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	"PregSense™ and Cardiotocopraphy (CTG)"	Cardiotocopraphy (CTG)
Arm/Group Description	PregSense™ wearable device was applied for maternal-fetal monitoring	Philips FM30 (CTG) was applied for maternal-fetal monitoring
Measure Participants	147	147
Mean (Standard Deviation) [bpm]	140.3 (11.9)	140.4 (11.65)

2. Primary Outcome

Title	Maternal Heart Rate
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PregSense™	Cardiotocopraphy (CTG)
Arm/Group Description	PregSense™ wearable device was applied for maternal-fetal monitoring	Philips FM30 Cardiotocopraphy (CTG) was applied for maternal-fetal monitoring
Measure Participants	147	147
Mean (Standard Deviation) [bpm]	89.3 (12.54)	89.1 (12.5)

3. Secondary Outcome

Title	Uterine Contractions
Description	Compare uterine contractions from Pregsense™ versus CTG.
Time Frame	30 Minutes

Outcome Measure Data

Analysis Population Description

Uterine Contraction information was eventually not collected AT ALL, therefore no population to describe.

Arm/Group Title	"PregSense™ and Cardiotocopraphy (CTG)"
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
Measure Participants	0

4. Other Pre-specified Outcome

Title	Safety Measures
Description	Evaluate device related adverse events
Time Frame	Through study completion, an average of 1 hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PregSense™
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
Measure Participants	147
Count of Participants [Participants]	0 0%

Adverse Events

Time Frame	30 minutes during Non stress test (NST)
Adverse Event Reporting Description	No adverse events reported during the trial
Arm/Group Title	PregSense™
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 (%)	# Events
Total	0/147 (0%)
Serious Adverse Events
	PregSense™
	Affected / at Risk (%)	# Events
Total	0/147 (0%)
Other (Not Including Serious) Adverse Events
	PregSense™
	Affected / at Risk (%)	# Events
Total	0/147 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.