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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: University of Arizona

Current Primary Outcome: Efficacy of the Novii when compared to the AN24 [ Time Frame: 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.


Original Primary Outcome: Efficacy of the AN25 when compared to the AN24 [ Time Frame: duration of the patient's labor ]

Both the AN24 device and the AN25 device will be placed on the patient's abdomen at the same time. After the patient has delivered their infant, the data from the AN25 will be downloaded and checked against that from the AN24 to assess for accuracy of fetal monitoring.


Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Arizona

Dates:
Date Received: May 1, 2013
Date Started: April 2013
Date Completion:
Last Updated: February 24, 2014
Last Verified: February 2014