NCT01889316

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 1, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 28, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

February 26, 2014

Status Verified

February 1, 2014

Enrollment Period

7 months

First QC Date

May 1, 2013

Last Update Submit

February 24, 2014

Conditions

Labor Fetal Anoxia

Keywords

Fetal monitoringECG

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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.

Device: NoviiDevice: AN24

Interventions

NoviiDEVICE

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

AN24 in addition to new device (Novii)
AN24DEVICE
AN24 in addition to new device (Novii)

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Term Laboring Patients

You may not qualify if:

  • Preterm Labor
  • Fetal Anomaly
  • Imminent cesarean

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center

Tucson, Arizona, 85724, United States

Location

Study Officials

  • Meg Hill, MBBS

    University of Arizona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 1, 2013

First Posted

June 28, 2013

Study Start

April 1, 2013

Primary Completion

November 1, 2013

Study Completion

January 1, 2014

Last Updated

February 26, 2014

Record last verified: 2014-02

Locations

US(1)