Labor Fetal Anoxia Clinical Trial
Official title:
Performance Comparison of a New Fetal/Maternal Monitor With an FDA-cleared Method
Verified date | February 2014 |
Source | University of Arizona |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 75 |
Est. completion date | January 2014 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Term Laboring Patients Exclusion Criteria: - Preterm Labor - Fetal Anomaly - Imminent cesarean |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | University Medical Center | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
University of Arizona |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
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