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 range

18 Years

Sex

FEMALE

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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