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Refinement of the OBMedical LaborView System

NCT03244865 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 35

Last updated 2019-09-20

Study results available
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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

Interventions

DEVICE

LaborView Electronic Fetal Monitor

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.

Sponsors & Collaborators

  • University of Florida

    collaborator OTHER

  • OBMedical Company

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-29
Primary Completion
2018-04-11
Completion
2018-04-11
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03244865 on ClinicalTrials.gov