| ID | Type | Description | Link |
|---|---|---|---|
| FWA00004218 | Other Identifier | Monica Healthcare |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AN24 in addition to new device (Novii) | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novii | Device | The Novii is a modified device with similar technology to the AN24 device already being used in the USA. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of the Novii when compared to the AN24 | 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. | duration of the patient's labor |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meg Hill, MBBS | University of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center | Tucson | Arizona | 85724 | United States |
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| AN24 | Device |
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