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

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