- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01730963
Multi-Reader Multi-Case Study to Identify Uterine Contractions Recorded From Laboring and Nonlaboring Patients by Practicing Clinicians
Study Overview
Status
Conditions
Detailed Description
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:
- Standard tocodynamometer attached to the maternal abdomen,
- 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Arizona
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Phoenix, Arizona, United States, 85013
- St. Joseph's Hospital and Medical Center
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19101
- Drexel University College of Medicine
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-
Texas
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Beaumont, Texas, United States, 77702
- Southeast Texas OB/GYN Associates
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Galveston, Texas, United States, 77555
- University of Texas Medical Branch
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Houston, Texas, United States, 77054
- Woman's Hospital of Texas
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Singleton Pregnancy
- Informed Consent Required
Exclusion Criteria:
- Multifetal Pregnancy
- Informed Consent Not Given
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of SureCALL® and Tocodynamometer Detection of Contraction Events, as Identified by Readers
Time Frame: 9 - 41 Minutes
|
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
|
Collaborators and Investigators
Investigators
- Study Director: Timothy B Waterhouse, MD, Reproductive Research Technologies, LP
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RRT-12-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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