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

February 24, 2014 updated by: Meg Hill, University of Arizona
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Term Laboring Patients

Exclusion Criteria:

  • Preterm Labor
  • Fetal Anomaly
  • Imminent cesarean

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
duration of the patient's labor

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Investigators

  • Principal Investigator: Meg Hill, MBBS, University of Arizona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

May 1, 2013

First Submitted That Met QC Criteria

June 27, 2013

First Posted (Estimate)

June 28, 2013

Study Record Updates

Last Update Posted (Estimate)

February 26, 2014

Last Update Submitted That Met QC Criteria

February 24, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-0197
  • FWA00004218 (Other Identifier: Monica Healthcare)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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