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

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University of Arizona

Status

Completed

Conditions

Labor Fetal Anoxia

Treatments

Device: AN24
Device: Novii

Study type

Interventional

Funder types

Other

Identifiers

NCT01889316
FWA00004218 (Other Identifier)
13-0197

Details and patient eligibility

About

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.

Full 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.

Enrollment

75 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Term Laboring Patients

Exclusion criteria

Preterm Labor Fetal Anomaly Imminent cesarean

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

75 participants in 1 patient group

AN24 in addition to new device (Novii)
Other group
Description:
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:
Device: Novii
Device: AN24

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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