NCT03504189

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable pregnancy

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 20, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2018

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

February 18, 2020

Completed
Last Updated

February 18, 2020

Status Verified

February 1, 2020

Enrollment Period

4 months

First QC Date

March 5, 2018

Results QC Date

January 13, 2019

Last Update Submit

February 6, 2020

Conditions

Pregnancy

Keywords

Fetal monitoring, Prenatal monitoring

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Uterine Contractions

    30 Minutes

Other Outcomes (1)

  • Safety Measures

    Through study completion, an average of 1 hour

Study Arms (1)

PregSense™

EXPERIMENTAL

PregSense™ wearable device and the standard of care CTG (cardiotocography) will be applied for maternal-fetal monitoring

Device: PregSense™Device: Cardiotocopraphy (CTG)

Interventions

PregSense™DEVICE

PregSense™ wearable device will be applied for maternal-fetal monitoring

PregSense™
Cardiotocopraphy (CTG)DEVICE

Cardiotocopraphy (CTG) will be applied for maternal-fetal monitoring

PregSense™

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant females
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female age between 18-50
  • Gestational age \> 32 + 0 weeks
  • Singleton gestation
  • Ability to understand and sign informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

Heidelberg University Womens Hospital

Heidelberg, Germany

Location

Hadassah-Hebrew University Medical Center

Jerusalem, Israel

Location

Related Publications (1)

  • 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.

    PMID: 33345967DERIVED

Results Point of Contact

Title
VP Clinical
Organization
Nuvo Group
adar.shani@nuvocares.com
+972-3-6242266

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Open Label
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2018

First Posted

April 20, 2018

Study Start

March 1, 2018

Primary Completion

June 27, 2018

Study Completion

November 8, 2018

Last Updated

February 18, 2020

Results First Posted

February 18, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)US(2)IL(1)