Noninvasive Monitoring of Uterine Activity and Fetal Heart Rate

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

Completed

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Key information

Conditions

Fetal Heart Rate or Rhythm Abnormality Affecting Newborn During Labor Obstetric Complication Uterine Contractions

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Meir Medical Center, Kfar Saba, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TrueLabor

Device

Non invasive monitoring device

Primary outcomes

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
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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

OB-Tools Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: Mar 23, 2023
Registry last updated: Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed