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

NCT01889316 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2014-02-26

No results posted yet for this study

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.

Conditions

  • Labor Fetal Anoxia

Interventions

DEVICE

Novii

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

DEVICE

AN24

Sponsors & Collaborators

  • University of Arizona

    lead OTHER

Principal Investigators

  • Meg Hill, MBBS · University of Arizona

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2013-11-30
Completion
2014-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01889316 on ClinicalTrials.gov