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

Completed · Not applicable

Conditions studied: Labor Fetal Anoxia

In brief

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.

Key facts

Study ID

NCT01889316

Run by

University of Arizona

People needed

75

Starts

2013-04-01

Expected to finish

2014-01-01

Last updated by the study team

2014-02-26

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Term Laboring Patients

You may not qualify if…

• Preterm Labor
• Fetal Anomaly
• Imminent cesarean

Where it is running

• University Medical Center — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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