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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant, Preterm, In Labor | Gestation Age at or less than 36 weeks, clinically determined to be in labor | ||
| Pregnant, Preterm, Nonlaboring | Gestation Age at or less than 36 weeks, clinically determined to not be in labor | ||
| Pregnant, Term, Nonlaboring | Gestation Age more than 36 weeks, clinically determined to not be in labor |
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| Measure | Description | Time Frame |
|---|---|---|
| Comparison of SureCALL® and Tocodynamometer Detection of Contraction Events, as Identified by Readers | Agreement will be assessed by coefficient of individual agreement (CIA) derived from a dataset of all Reader-marked contractions. In addition, sensitivity and false positive rate per hours will be estimated for each patient by each reader. If CIA ≥ 0.445 (Barnhart, 2007, section 3) or CIA>0.8, Pan 2010), the SureCALL® is not significantly different than the TOCO. | 9 - 41 Minutes |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant women with uncomplicated singleton pregnancies
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| Name | Affiliation | Role |
|---|---|---|
| Timothy B Waterhouse, MD | Reproductive Research Technologies, LP | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Hospital and Medical Center | Phoenix | Arizona | 85013 | United States | ||
| Drexel University College of Medicine |
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| Philadelphia |
| Pennsylvania |
| 19101 |
| United States |
| Southeast Texas OB/GYN Associates | Beaumont | Texas | 77702 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
| Woman's Hospital of Texas | Houston | Texas | 77054 | United States |