Pregnancy Clinical Trial
Official title:
Multi-Reader Multi-Case Study to Identify Uterine Contractions Recorded From Laboring and Nonlaboring Patients by Practicing Clinicians
This multi-reader multi-case study was designed to evaluate the performance of SureCALL® Labor Monitor® (SureCALL®) directly to the standard Tocodynamometer device (TOCO).
The SureCALL® Labor Monitor® (SureCALL®) is a transabdominal electromyography monitor
intended to measure uterine activity. It is intended for use on pregnant women, with
singleton pregnancies, using surface electrodes on the maternal abdomen. The device is
intended for use by healthcare professionals in a clinical setting.
This multi-reader multi-case study was designed to evaluate the performance of SureCALL® to
the predicate Tocodynamometer device (TOCO).
This study involved 25 women at a Gestational Age of 36 weeks or less and 5 women at a
Gestation Age of greater than 36 and not in labor at five clinical sites. Each study subject
was instrumented with two technologies for measuring uterine activity:
1. Standard tocodynamometer attached to the maternal abdomen,
2. SureCALL® with a set of abdominal surface electrodes for uterine electromyography
attached to the maternal abdomen
An assessment was obtained and quantified from masked, qualified clinical obstetrician
readers for the evaluation of the equivalence of both labor monitor devices by identifying
in isolation the individual uterine contraction signals and the peak of each contraction
signal as recorded by each labor monitor device.
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Observational Model: Case-Only, Time Perspective: Cross-Sectional
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