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NCT05782296 Clinical Trial

Noninvasive Monitoring of Uterine Activity and Fetal Heart Rate

Obstetric Complication Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05782296
Other study ID # CL-00002
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 24, 2022
Est. completion date April 30, 2024

Study information
Verified date April 2024
Source OB-Tools Ltd.
Contact Elon Reshef
Phone +972-4-6040162
Email elon.reshef@ob-tools.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date April 30, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• TrueLabor
Non invasive monitoring device

Locations
Country Name City State
Israel Meir Medical Center Kfar Saba
United States Montefiore Medical Center Bronx New York
United States Ascension Illinois Saint Alexius Residency Program in Obstetrics and Gynecology Hoffman Estates Illinois

Sponsors (1)
Lead Sponsor Collaborator
OB-Tools Ltd.

Countries where clinical trial is conducted

United States,  Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety, comparative performance, and reliability of the TrueLabor™ system for Fetal Heart Rate This will be performed using a Performance Goal Through labor, until delivery
Primary Safety, comparative performance, and reliability of the TrueLabor™ system for Uterine Activity This will be performed using a Performance Goal Through labor, until delivery
Secondary Effect of BMI (weight in Kg, height in meters will be combined to report BMI in kg/m2) Effect of BMI on the performance measures Through labor, until delivery
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