Comparison of SureCALL® Labor Monitor® and Tocodynamometer Measurement in Preterm and Term Pregnant Women
NCT ID: NCT01399229
Last Updated: 2013-09-12
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
30 participants
OBSERVATIONAL
2007-01-31
2011-12-31
Brief Summary
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Detailed Description
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This measurement study was designed to evaluate the performance of SureCALL® Labor Monitor® (SureCALL®) compared to the predicate Tocodynamometer device (TOCO) in pregnant laboring preterm patients, nonlaboring preterm patients, and nonlaboring term patients.
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 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
Subjects did not recieve any interventions as a part of this study.
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-11-01
Identifier Type: -
Identifier Source: org_study_id