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Noninvasive Monitoring of Uterine Activity and Fetal Heart Rate | Clinical Trials | Clareo Health

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Noninvasive Monitoring of Uterine Activity and Fetal Heart Rate

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

NCT05782296•OB-Tools Ltd.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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

Locations (3)

Ascension Illinois Saint Alexius Residency Program in Obstetrics and Gynecology

Hoffman Estates, Illinois, United States

Montefiore Medical Center

The Bronx, New York, United States

Meir Medical Center

Kfar Saba, Israel

Key Dates

Start Date

February 24, 2022

Primary Completion Date

June 5, 2024

Completion Date

June 5, 2024

Last Updated

March 27, 2025

Enrollment

ACTUAL participants

Conditions

Fetal Heart Rate or Rhythm Abnormality Affecting Newborn During LaborUterine ContractionsObstetric Complication

Interventions

TrueLabor

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 27, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Noninvasive Monitoring of Uterine Activity and Fetal Heart Rate

Inclusion Criteria

Exclusion Criteria

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