Performance Comparison of a New Fetal/Maternal Monitor With an FDA-cleared Method
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Labor Fetal Anoxia
- Sponsor
- University of Arizona
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Efficacy of the Novii when compared to the AN24
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Meg Hill
Principal Investigator
University of Arizona
Eligibility Criteria
Inclusion Criteria
- •Term Laboring Patients
Exclusion Criteria
- •Preterm Labor
- •Fetal Anomaly
- •Imminent cesarean
Outcomes
Primary Outcomes
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.