Multi-Reader Multi-Case Study to Identify Uterine Contractions Recorded From Laboring and Nonlaboring Patients by Practicing Clinicians
NCT ID: NCT01730963
Last Updated: 2012-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2007-01-31
2012-09-30
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).
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.
Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Pregnant, Preterm, In Labor
Gestation Age at or less than 36 weeks, clinically determined to be in labor
No interventions assigned to this group
Pregnant, Preterm, Nonlaboring
Gestation Age at or less than 36 weeks, clinically determined to not be in labor
No interventions assigned to this group
Pregnant, Term, Nonlaboring
Gestation Age more than 36 weeks, clinically determined to not be in labor
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Informed Consent Required
Exclusion Criteria
* Informed Consent Not Given
18 Years
40 Years
FEMALE
No
Sponsors
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Reproductive Research Technologies, LP
INDUSTRY
Responsible Party
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Principal Investigators
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Timothy B Waterhouse, MD
Role: STUDY_DIRECTOR
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
Southeast Texas OB/GYN Associates
Beaumont, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
Woman's Hospital of Texas
Houston, Texas, United States
Countries
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Other Identifiers
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RRT-12-01
Identifier Type: -
Identifier Source: org_study_id