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

N/A

Waitlist Available

Led By Meg Hill, MBBS

Research Sponsored by University of Arizona

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Term Laboring Patients

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up duration of the patient's labor

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Birth Asphyxia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ duration of the patient's labor

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~duration of the patient's labor

This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of the patient's labor for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy of the Novii when compared to the AN24

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: AN24 in addition to new device (Novii)Experimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Novii

2013

N/A

~80

AN24

2013

N/A

~80