Back to resultsPerformance Comparison of a New Fetal/Maternal Monitor With an FDA-cleared Method
Primary Purpose
Labor Fetal Anoxia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Novii
AN24
Sponsored by
About this trial
This is an interventional supportive care trial for Labor Fetal Anoxia focused on measuring Fetal monitoring, ECG
Eligibility Criteria
Inclusion Criteria:
- Term Laboring Patients
Exclusion Criteria:
- Preterm Labor
- Fetal Anomaly
- Imminent cesarean
Sites / Locations
- University Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
AN24 in addition to new device (Novii)
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01889316
Brief Title
Performance Comparison of a New Fetal/Maternal Monitor With an FDA-cleared Method
Official Title
Performance Comparison of a New Fetal/Maternal Monitor With an FDA-cleared Method
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arizona
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Fetal Anoxia
Keywords
Fetal monitoring, ECG
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AN24 in addition to new device (Novii)
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Novii
Intervention Description
The Novii is a modified device with similar technology to the AN24 device already being used in the USA.
Intervention Type
Device
Intervention Name(s)
AN24
Primary Outcome Measure Information:
Title
Efficacy of the Novii when compared to the AN24
Description
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.
Time Frame
duration of the patient's labor
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Term Laboring Patients
Exclusion Criteria:
Preterm Labor
Fetal Anomaly
Imminent cesarean
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meg Hill, MBBS
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Performance Comparison of a New Fetal/Maternal Monitor With an FDA-cleared Method
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