CompletedNot Applicable

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

United States75 participantsStarted 2013-04

Plain-language 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 also created by Monica Healthcare) using the same technology with different monitor placement.

Who can participate

Age range18 Years – 50 Years

SexFEMALE

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Inclusion Criteria: * Term Laboring Patients Exclusion Criteria: * Preterm Labor * Fetal Anomaly * Imminent cesarean

What they're measuring

Efficacy of the Novii when compared to the AN24

Timeframe: duration of the patient's labor

Trial details

NCT IDNCT01889316

SponsorUniversity of Arizona

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-11

View on ClinicalTrials.gov More Labor Fetal Anoxia trials