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

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Labor Fetal Anoxia Device: Novii Device: AN24 Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Performance Comparison of a New Fetal/Maternal Monitor With an FDA-cleared Method
Study Start Date : April 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : January 2014
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889316


Locations
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United States, Arizona
University Medical Center
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
University of Arizona
Investigators
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Principal Investigator: Meg Hill, MBBS University of Arizona
More Information
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Responsible Party: Meg Hill, Principal Investigator, University of Arizona
ClinicalTrials.gov Identifier: NCT01889316    
Obsolete Identifiers: NCT02041949
Other Study ID Numbers: 13-0197
FWA00004218 ( Other Identifier: Monica Healthcare )
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: February 26, 2014
Last Verified: February 2014
Keywords provided by Meg Hill, University of Arizona:
Fetal monitoring
ECG
Additional relevant MeSH terms:
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Fetal Hypoxia
Hypoxia
Signs and Symptoms, Respiratory
Fetal Diseases
Pregnancy Complications