Noninvasive Monitoring of Uterine Activity and Fetal Heart Rate

Recruiting

• Conditions: Fetal Heart Rate or Rhythm Abnormality Affecting Newborn During Labor; Obstetric Complication; Uterine Contractions
• Interventions: Device: TrueLabor

• Registration Number: NCT05782296
• Lead Sponsor: OB-Tools Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-24
• Study First Submitted: 2022-02-28
• Study First Submitted QC: 2023-03-12
• Study First Posted: 2023-03-23
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-03
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort	TrueLabor	Women in active labor following rupture of membranes and placement of an IUPC and/or FSE for obstetric indications

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Ascension Illinois Saint Alexius Residency Program in Obstetrics and Gynecology; 🇺🇸 Hoffman Estates, Illinois, United States

Meir Medical Center; 🇮🇱 Kfar Saba, Israel

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States