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OpenTrials
Completed

NCT Number: NCT01889316

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

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.

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Key information

Conditions

Labor Fetal Anoxia

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center

Tucson, Arizona, 85724, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Term Laboring Patients

Exclusion criteria

  • Preterm Labor
  • Fetal Anomaly
  • Imminent cesarean

Treatment and study plan

Novii

Device

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

AN24

Device

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Jun 28, 2013
Registry last updated
Feb 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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