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

Clinical Study Evaluating the Safety of PregSense and Comparative Performance of PregSense Versus CTG in Prenatal Monitoring of Pregnant Subjects

This clinical study will evaluate the safety of PregSense™ and Comparative Performance of PregSense™ versus CTG in Prenatal Monitoring of Pregnant subjects.

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Device: PregSense™; Device: Cardiotocopraphy (CTG)

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: Interventional
• Enrollment (Actual): 151
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany
    • Heidelberg University Womens Hospital
• Israel
  • Jerusalem, Israel
    • Hadassah-Hebrew University Medical Center
• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Eastern Virginia Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fetal Heart Rate	Provide evidence of safety and FHR agreement between PregSense™ and the standard of care devices (i.e. CTG)	30 Minutes
Maternal Heart Rate	Provide evidence of safety and agreement between MHR collected via the PregSense™ and the standard of care devices (i.e. CTG)	30 MInutes

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nuvo-Group, Ltd.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): June 27, 2018
• Study Completion (Actual): November 8, 2018

Study Registration Dates

• First Submitted: March 5, 2018
• First Submitted That Met QC Criteria: April 19, 2018
• First Posted (Actual): April 20, 2018

Study Record Updates

• Last Update Posted (Actual): February 18, 2020
• Last Update Submitted That Met QC Criteria: February 6, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Fetal monitoring, Prenatal monitoring
• Other Study ID Numbers: CLP1000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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