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

Labor Fetal Anoxia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01889316
• Other study ID #: 13-0197
• Secondary ID: FWA00004218
• Status: Completed
• Phase: N/A
• First received: May 1, 2013
• Last updated: February 24, 2014
• Start date: April 2013
• Est. completion date: January 2014

Study information

• Verified date: February 2014
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT02041949

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: January 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Term Laboring Patients

Exclusion Criteria:

• Preterm Labor

• Fetal Anomaly

• Imminent cesarean

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Labor Fetal Anoxia

Intervention

Device:
• Novii
The Novii is a modified device with similar technology to the AN24 device already being used in the USA.
• AN24

Locations

Country	Name	City	State
United States	University Medical Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of the Novii when compared to the AN24	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.	duration of the patient's labor	No