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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01889316
Recruitment Status : Completed
First Posted : June 28, 2013
Last Update Posted : February 26, 2014
Sponsor:
Information provided by (Responsible Party):
Meg Hill, University of Arizona

Tracking Information
First Submitted Date  ICMJE May 1, 2013
First Posted Date  ICMJE June 28, 2013
Last Update Posted Date February 26, 2014
Study Start Date  ICMJE April 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 27, 2013)
Efficacy of the AN25 when compared to the AN24 [ Time Frame: duration of the patient's labor ]
Both the AN24 device and the AN25 device will be placed on the patient's abdomen at the same time. After the patient has delivered their infant, the data from the AN25 will be downloaded and checked against that from the AN24 to assess for accuracy of fetal monitoring.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Performance Comparison of a New Fetal/Maternal Monitor With an FDA-cleared Method
Official Title  ICMJE 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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Labor Fetal Anoxia
Intervention  ICMJE
  • Device: Novii
    The Novii is a modified device with similar technology to the AN24 device already being used in the USA.
  • Device: AN24
Study Arms  ICMJE 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.

Interventions:
  • Device: Novii
  • Device: AN24
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 24, 2014)
75
Original Estimated Enrollment  ICMJE
 (submitted: June 27, 2013)
45
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Term Laboring Patients

Exclusion Criteria:

  • Preterm Labor
  • Fetal Anomaly
  • Imminent cesarean
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01889316
Other Study ID Numbers  ICMJE 13-0197
FWA00004218 ( Other Identifier: Monica Healthcare )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Meg Hill, University of Arizona
Study Sponsor  ICMJE University of Arizona
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Meg Hill, MBBS University of Arizona
PRS Account University of Arizona
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP