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

• ClinicalTrials.gov Identifier: NCT01889316
• Recruitment Status: Completed
• First Posted: June 28, 2013
• Last Update Posted: February 26, 2014
• Sponsor: University of Arizona
• Information provided by (Responsible Party): Meg Hill, University of Arizona

Tracking Information

• First Submitted Date: May 1, 2013
• First Posted Date: June 28, 2013
• Last Update Posted Date: February 26, 2014
• Study Start Date: April 2013
• Actual Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 24, 2014)

Efficacy of the Novii when compared to the AN24 [ Time Frame: 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.

Original Primary Outcome Measures (submitted: June 27, 2013)

Efficacy of the AN25 when compared to the AN24 [ Time Frame: duration of the patient's labor ]

Both the AN24 device and the AN25 device will be placed on the patient's abdomen at the same time. After the patient has delivered their infant, the data from the AN25 will be downloaded and checked against that from the AN24 to assess for accuracy of fetal monitoring.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Performance Comparison of a New Fetal/Maternal Monitor With an FDA-cleared Method
• Official Title: Performance Comparison of a New Fetal/Maternal Monitor With an FDA-cleared Method
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Labor Fetal Anoxia

Intervention

• Device: Novii
  The Novii is a modified device with similar technology to the AN24 device already being used in the USA.
• Device: AN24

Study Arms

AN24 in addition to new device (Novii)

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.

Interventions:

• Device: Novii
• Device: AN24

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 24, 2014): 75
• Original Estimated Enrollment (submitted: June 27, 2013): 45
• Actual Study Completion Date: January 2014
• Actual Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Term Laboring Patients

Exclusion Criteria:

• Preterm Labor
• Fetal Anomaly
• Imminent cesarean

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01889316
• Other Study ID Numbers: 13-0197; FWA00004218 ( Other Identifier: Monica Healthcare )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Meg Hill, University of Arizona
• Study Sponsor: University of Arizona
• Collaborators: Not Provided

Investigators

• Principal Investigator: Meg Hill, MBBS; University of Arizona

• PRS Account: University of Arizona
• Verification Date: February 2014