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Multichannel EMG Diagnosing True Preterm Labor

NCT03785795 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 23

Last updated 2020-02-12

No results posted yet for this study

Summary

We have designed new electromyography sensors for measuring uterine activity. These sensors are directional - they preferentially report uterine muscle contractions at specific locations, called regions. By measuring the synchronization of the regions of the uterus during contractions we intend to non-invasively determine if any patient is in-labor or not-in-labor. Accurately diagnosing true preterm labor allows timely intervention to avoid preterm birth; Accurately diagnosing false preterm labor avoids needlessly treating patients who would not benefit.

Conditions

  • Pregnancy Preterm
  • Labor; Irregular
  • Preterm Labor

Interventions

DEVICE

Uncertain diagnosis of true labor

Multichannel EMG of uterine bioelectrical signals will be recorded using area sensors. The output of the synchronization calculations will be correlated with the time to delivery

Sponsors & Collaborators

  • University of Rochester

    collaborator OTHER

  • PreTeL, Inc

    lead INDUSTRY

Principal Investigators

  • Roger C Young, MD · PreTeL, Inc

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-25
Primary Completion
2020-01-10
Completion
2020-01-10
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT03785795 on ClinicalTrials.gov