Trial Outcomes & Findings for Evaluating the Safety of PregSense™ and Compare Its Performance to CTG in Prenatal Monitoring of Pregnant Subjects (NCT NCT03504189)

NCT ID: NCT03504189

Last Updated: 2020-02-18

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 151 participants
• Primary outcome timeframe: 30 Minutes
• Results posted on: 2020-02-18

Participant Flow

Participant milestones

Measure	"PregSense™ and Cardiotocopraphy (CTG)" 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.
Overall Study STARTED	151
Overall Study COMPLETED	147
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	"PregSense™ and Cardiotocopraphy (CTG)" 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.
Overall Study Withdrawal by Subject	1
Overall Study Screening Failure	1
Overall Study Device Failure	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	PregSense™ n=147 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	147 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	31.8 years STANDARD_DEVIATION 6.89 • n=5 Participants
Sex: Female, Male Female	147 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	140 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Region of Enrollment United States	69 Participants n=5 Participants
Region of Enrollment Israel	49 Participants n=5 Participants
Region of Enrollment Germany	31 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 Minutes

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

Outcome measures

Measure	"PregSense™ and Cardiotocopraphy (CTG)" n=147 Participants PregSense™ wearable device was applied for maternal-fetal monitoring	Cardiotocopraphy (CTG) n=147 Participants Philips FM30 (CTG) was applied for maternal-fetal monitoring
Fetal Heart Rate	140.3 bpm Standard Deviation 11.9	140.4 bpm Standard Deviation 11.65

PRIMARY outcome

Timeframe: 30 MInutes

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

Outcome measures

Measure	"PregSense™ and Cardiotocopraphy (CTG)" n=147 Participants PregSense™ wearable device was applied for maternal-fetal monitoring	Cardiotocopraphy (CTG) n=147 Participants Philips FM30 (CTG) was applied for maternal-fetal monitoring
Maternal Heart Rate	89.3 bpm Standard Deviation 12.54	89.1 bpm Standard Deviation 12.5

SECONDARY outcome

Timeframe: 30 Minutes

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

Compare uterine contractions from Pregsense™ versus CTG.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Through study completion, an average of 1 hour

Evaluate device related adverse events

Outcome measures

Measure	"PregSense™ and Cardiotocopraphy (CTG)" n=147 Participants PregSense™ wearable device was applied for maternal-fetal monitoring	Cardiotocopraphy (CTG) Philips FM30 (CTG) was applied for maternal-fetal monitoring
Safety Measures	0 Participants	—

Adverse Events

PregSense™

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

VP Clinical

Nuvo Group

Phone: +972-3-6242266

Email: adar.shani@nuvocares.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place