CompletedNot Applicable

Noninvasive Monitoring of Uterine Activity and Fetal Heart Rate

United States, Israel80 participantsStarted 2022-02-24

Plain-language summary

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

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Safety, comparative performance, and reliability of the TrueLabor™ system for Fetal Heart Rate

Timeframe: Through labor, until delivery

Safety, comparative performance, and reliability of the TrueLabor™ system for Uterine Activity

Timeframe: Through labor, until delivery

Trial details

NCT IDNCT05782296

SponsorOB-Tools Ltd.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-06-05

View on ClinicalTrials.gov More Fetal Heart Rate or Rhythm Abnormality Affecting Newborn During Labor trials