Multi-Reader Multi-Case Study to Identify Uterine Contractions Recorded From Laboring Patients by Practicing Clinicians
NCT ID: NCT01282723
Last Updated: 2011-03-15
Study Results
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View full resultsBasic Information
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COMPLETED
20 participants
OBSERVATIONAL
2008-08-31
2010-01-31
Brief Summary
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Detailed Description
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This multi-reader multi-case study was designed to evaluate the performance of SureCALL® to the predicate Tocodynamometer device (TOCO) using the performance of an Intrauterine Pressure Catheter device (IUPC) as the "gold standard".
This study involved 20 women at term, in labor, at three clinical sites. Each study subject was instrumented with three technologies for measuring uterine activity:
1. a tocodynamometer attached to the maternal abdomen
2. a set of abdominal surface electrodes for uterine electromyography, and
3. an intrauterine pressure catheter.
An assessment was obtained and quantified from masked, qualified clinical obstetrician readers for the evaluation of the equivalence of the three independent labor monitor devices by identifying in isolation the individual uterine contraction signals and the peak of each contraction signal produced by a full-term patient in term labor as independently collected by each labor monitor device.
Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Pregnant, In Labor
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Indicated for IUPC
* Gestational ages from 37 to 41 weeks
* Informed consent required
Exclusion Criteria
* Not Indicated for IUPC
* Gestation age below 37 or above 41 weeks
* Informed consent not given
15 Years
40 Years
FEMALE
No
Sponsors
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Reproductive Research Technologies, LP
INDUSTRY
Responsible Party
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Reproductive Research Technologies, LP
Principal Investigators
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Timothy B Waterhouse, MD
Role: PRINCIPAL_INVESTIGATOR
Reproductive Research Technologies, LP
Locations
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St.Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States
University of Texas Medical Branch
Galveston, Texas, United States
Countries
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Other Identifiers
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RRT-10-01
Identifier Type: -
Identifier Source: org_study_id
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