Refinement of the OBMedical LaborView System

NCT03244865 | Completed Results FDA Device

• 1 other identifier: PRO00009835
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Despite its limitations, fetal heart rate (FHR) tracing analysis is the best monitor of fetal well-being during labor or preparation for cesarean delivery. Current monitoring methods: transabdominal ultrasound (CTG: cardiotocograph) and fetal scalp electrodes (FSE) have limitations (tracing loss during fetal movement, potential to confuse maternal for fetal heart rate, inability to monitor during cesarean section or abdominal surgery) and, in the latter case, risks (infection, hematoma). A reliable, non-invasive monitor of the fetal heart rate that can be used during labor, non-obstetric and obstetric surgery during pregnancy is needed. Recent developments in use of maternal abdominal electrodes for extraction of the FHR and contraction information inform this study. LaborView®, developed by researchers at University of Florida (UF) College of Medicine and OBMedical, is an FDA-approved non-invasive labor monitoring device. Refinement of the extraction algorithms continues, and that work is most effectively performed at UF, where the primary researchers and OBMedical are located. LaborView monitoring will be recorded from up to150 subjects admitted to Labor and Delivery at UFHealth. Data will be simultaneously obtained from the standard labor monitor. These signals will then be analyzed off-line for comparison and refinement of algorithms.

Conditions

Fetal Monitoring

Outcome Measures

Primary Outcomes (1)

• Fetal Heart Rate With the Laborview System Versus the CTG Monitor - Pilot Comparison Study

  Using standard of care CTG (Cardiotocography) already in place and the LaborView electrode-based FHR monitoring simultaneously, we will collect FHR data from both monitors simultaneously. We will compare the two FHR calculations using root mean squared error (RMSE).

  1 - 8 hours

Study Arms (1)

Pregnant Females

All patients admitted to the Labor \& Delivery Suite at UF Health, will be eligible for inclusion in the study except minors and those unable to consent for themselves. Nothing is required of the subjects. They will be non-invasively monitored for one to several hours. The information obtained will not be used for medical decision-making and there is no significant risk to the patient or her fetus. No longitudinal follow-up is planned or indicated.

Device: LaborView Electronic Fetal Monitor

Interventions

LaborView Electronic Fetal Monitor DEVICE

Per LaborView directions, electrode application sites will be prepared to reduce skin impedance, electrodes will be applied to the maternal abdomen and FHR data acquired for comparison with CTG data obtained through the traditional monitoring system. The comparison will be performed off-line. Nothing is required of the subjects. They will be non-invasively monitored for one to several hours. The information obtained will not be used for medical decision-making and there is no significant risk to the patient or her fetus.

Pregnant Females

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Only Pregnant Females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant Females admitted to Labor and Delivery at Shands UF Health who are over the age of 18 and able to consent themselves.

You may qualify if:

• Admitted to Labor and Delivery at Shands UF Health
• Are able to consent for themselves

You may not qualify if:

• Under the age of 18

Sponsors & Collaborators

• OBMedical Company: lead
• University of Florida: collaborator

Study Sites (1)

University of Florida Shands Health

Gainesville, Florida, 32608, United States

Location

Results Point of Contact

• Title: Dr. Tammy Euliano
• Organization: UF Health Department of Anesthesiology

teuliano@anest.ufl.edu

352-514-7460

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2017
• First Posted: August 10, 2017
• Study Start: September 29, 2016
• Primary Completion: April 11, 2018
• Study Completion: April 11, 2018
• Last Updated: September 20, 2019
• Results First Posted: September 20, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)