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Labor Status Monitor for Diagnosing True vs False Labor in Preterm Patients

NCT06157203 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 181

Last updated 2023-12-05

No results posted yet for this study

Summary

This is an observational study of pregnant persons in threatened labor. The study device will record electromyography signals, then the signals will be examined to determine who is in true labor and who is in threatened labor. The two goals are:

* To establish the thresholds for the Contraction Synchronization Index (CSI) and the False Labor Index (FSI) to be used by the Labor Status Monitor to diagnose in-Labor or Not-in-Labor for preterm patients with threatened labor
* To obtain feedback from subjects and providers to assist with enhancing patient comfort and provider training.

Conditions

Interventions

DEVICE

Uterine electromyography

electromyographic and fetal electrocardiographic recordings will be obtained during threatened labor

Sponsors & Collaborators

  • University of Rochester

    collaborator OTHER

  • Duke University

    collaborator OTHER

  • PreTeL, Inc

    lead INDUSTRY

Principal Investigators

  • Roger C Young, MD · PreTeL Chief Medical Officer

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-06
Primary Completion
2024-08-28
Completion
2024-10-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06157203 on ClinicalTrials.gov