Refinement of the OBMedical LaborView System

Completed

Conditions studied: Fetal Monitoring

In brief

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.

Key facts

Study ID
NCT03244865
Run by
OBMedical Company
People needed
35
Starts
2016-09-29
Expected to finish
2018-04-11
Last updated by the study team
2019-09-20

Who can join

Age: 18 and older, up to 100. Sex: female. Healthy volunteers: accepted.

You may qualify if…

You may not qualify if…

Where it is running

Full record on ClinicalTrials.gov

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