Status:

COMPLETED

Performance Comparison of a New Fetal/Maternal Monitor With an FDA-cleared Method

Lead Sponsor:

University of Arizona

Conditions:

Labor Fetal Anoxia

Eligibility:

FEMALE

18-50 years

Phase:

NA

Brief Summary

This is a prospective clinical trial involving the use of the FDA-cleared Fetal ECG tracing in labor with the AN24 (Fetal Monitoring device marketed by Monica Healthcare) to the Novii (a newer device ...

Detailed Description

This study has one arm, in which Both the FDA - Approved AN24 (Fetal Monitoring device marketed by Monica Healthcare) and the new device (Novii, being investigated in this clinical trial) will be plac...

Eligibility Criteria

Inclusion

  • Term Laboring Patients

Exclusion

  • Preterm Labor
  • Fetal Anomaly
  • Imminent cesarean

Key Trial Info

Start Date :

April 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2014

Estimated Enrollment :

75 Patients enrolled

Trial Details

Trial ID

NCT01889316

Start Date

April 1 2013

End Date

January 1 2014

Last Update

February 26 2014

Active Locations (1)

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Page 1 of 1 (1 locations)

1

University Medical Center

Tucson, Arizona, United States, 85724