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

Not Applicable

Completed

• Conditions: Labor Fetal Anoxia
• Interventions: Device: Novii; Device: AN24

• Registration Number: NCT01889316
• Lead Sponsor: University of Arizona

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

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 placed on the patient's abdomen. After delivery of the patient's infant, the data will be abstracted from the second device. This data will be compared to the data from the first device for accuracy.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-05-01
• Study First Submitted QC: 2013-06-27
• Study First Posted: 2013-06-28
• Primary Completion: 2013-11
• Study Completion: 2014-01
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-24
• Last Update Posted: 2014-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 75

Inclusion Criteria

• Term Laboring Patients

Exclusion Criteria

• Preterm Labor
• Fetal Anomaly
• Imminent cesarean

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AN24 in addition to new device (Novii)	Novii	FDA-cleared device (The AN24 device) used in conjunction with the new device (Novii). Both devices will be placed on the patient's abdomen. Hence the patient acts as their own control.
AN24 in addition to new device (Novii)	AN24	FDA-cleared device (The AN24 device) used in conjunction with the new device (Novii). Both devices will be placed on the patient's abdomen. Hence the patient acts as their own control.

Primary Outcome Measures

Name	Time	Method
Efficacy of the Novii when compared to the AN24	duration of the patient's labor	Both the AN24 device and the Novii device will be placed on the patient's abdomen at the same time. After the patient has delivered their infant, the data from the Novii will be downloaded and checked against that from the AN24 to assess for accuracy of fetal monitoring.

Trial Locations

Locations (1)

University Medical Center; 🇺🇸 Tucson, Arizona, United States