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