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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Meg Hill, University of Arizona
ClinicalTrials.gov Identifier:
NCT01889316
First received: May 1, 2013
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Labor Fetal Anoxia
Device: Novii
Device: AN24

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Performance Comparison of a New Fetal/Maternal Monitor With an FDA-cleared Method

Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • Efficacy of the Novii when compared to the AN24 [ Time Frame: duration of the patient's labor ] [ Designated as safety issue: No ]
    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.


Enrollment: 75
Study Start Date: April 2013
Study Completion Date: January 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
AN24 in addition to new device (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.

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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Term Laboring Patients

Exclusion Criteria:

  • Preterm Labor
  • Fetal Anomaly
  • Imminent cesarean
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01889316

Locations
United States, Arizona
University Medical Center
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
University of Arizona
Investigators
Principal Investigator: Meg Hill, MBBS University of Arizona
  More Information

No publications provided

Responsible Party: Meg Hill, Principal Investigator, University of Arizona
ClinicalTrials.gov Identifier: NCT01889316     History of Changes
Obsolete Identifiers: NCT02041949
Other Study ID Numbers: 13-0197, FWA00004218
Study First Received: May 1, 2013
Last Updated: February 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arizona:
Fetal monitoring
ECG

ClinicalTrials.gov processed this record on September 16, 2014