Labor Fetal Anoxia
Conditions
Keywords
Fetal monitoring, ECG
Brief 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.
Detailed 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.
Interventions
DEVICENovii
The Novii is a modified device with similar technology to the AN24 device already being used in the USA.
DEVICEAN24
Sponsors
University of Arizona
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Term Laboring Patients
Exclusion criteria
* Preterm Labor * Fetal Anomaly * Imminent cesarean
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of the Novii when compared to the AN24 | 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. |
Countries
United States
Outcome results
None listed