Noninvasive Monitoring of Uterine Activity and Fetal Heart Rate

April 1, 2024 updated by: OB-Tools Ltd.

Noninvasive Monitoring of Uterine Activity and Fetal Heart Rate: TrueLabor™, A New External Monitoring Device: Prospective Observational Study

A clinical study designed to validate the safety and performance of the TrueLabor™ device in monitoring labor vs. current standard of care.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Kfar Saba, Israel
        • Recruiting
        • Meir Medical Center
        • Principal Investigator:
          • Gil Shechter Maor, M.D
        • Contact:
  • United States
    • Illinois
      • Hoffman Estates, Illinois, United States, 60169
        • Recruiting
        • Ascension Illinois Saint Alexius Residency Program in Obstetrics and Gynecology
        • Contact:
        • Principal Investigator:
          • Marko Jachtorowycz, M.D.
    • New York
      • Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center
        • Contact:
        • Principal Investigator:
          • Dimitrios Mastrogiannis, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women (age>18 y/o) in active labor following rupture of membranes and placement of an IUPC and/or FSE.

Description

Inclusion Criteria:

  • Women who are on >=37w0d of gestation
  • Maternal age > 18 years old
  • Singleton pregnancy
  • Cephalic presentation
  • Patient requiring internal monitoring for obstetric indications
  • Informed consent

Exclusion Criteria:

  • Major fetal anomalies
  • Patients with implanted electronic devices of any kind
  • Patients using exterior electronic devices of any kind during the procedure
  • Patients with irritated skin or open wound on the abdominal wall

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort
Women in active labor following rupture of membranes and placement of an IUPC and/or FSE for obstetric indications
Device: TrueLabor
Non invasive monitoring device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety, comparative performance, and reliability of the TrueLabor™ system for Fetal Heart Rate
Time Frame: Through labor, until delivery
This will be performed using a Performance Goal
Through labor, until delivery
Safety, comparative performance, and reliability of the TrueLabor™ system for Uterine Activity
Time Frame: Through labor, until delivery
This will be performed using a Performance Goal
Through labor, until delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of BMI (weight in Kg, height in meters will be combined to report BMI in kg/m2)
Time Frame: Through labor, until delivery
Effect of BMI on the performance measures
Through labor, until delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OB-Tools Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2022

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

February 28, 2022

First Submitted That Met QC Criteria

March 12, 2023

First Posted (Actual)

March 23, 2023

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL-00002

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

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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