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Noninvasive Monitoring of Uterine Electrical Activity and Fetal Heart Rate: A New External Monitoring Device

NCT02993354 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 48

Last updated 2024-03-08

Study results available
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Summary

The EUM (electrical uterine myography) (OB Tools, Israel) was tested and found to be reliable as a non-invasive method for evaluating uterine contractions and the fetal heart rate. It is safe and effective in monitoring uterine contractions. The investigators propose to perform a study to validate the accuracy and clinical usefulness of the EUM device by simultaneously monitoring obese patients with current method of external tocodynamometry with the EUM device. Providers will be blinded to the results of the EUM device. Caregivers will continue care as per current guidelines using the information obtained from the current monitoring methods. Information obtained from the EUM devices will not be used to determine the clinical course of action.

Conditions

  • Contraction

Interventions

DEVICE

The EUM300 (electrical uterine myography)

This study involves monitoring one group of pregnant women for contractions simultaneously using two different devices to determine if one is superior: the usual tocodynamometer commonly used. Women are simultaneously monitored with both devices.

Sponsors & Collaborators

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Peter Bernstein, MD · Montefiore Medical Center

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2021-09-21
Completion
2021-09-21
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 NCT02993354 on ClinicalTrials.gov