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This multi-reader multi-case study was designed to evaluate the performance of SureCALL® EMG Labor Monitor® (SureCALL®)to the predicate Tocodynamometer device (TOCO) using the performance of an Intrauterine Pressure Catheter device (IUPC) as the "gold standard".
The SureCALL® EMG Labor Monitor® (SureCALL®)is a transabdominal electromyography monitor intended to measure intrapartum uterine activity. It is intended for use on term pregnant women who are in labor, 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) 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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant, In Labor |
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| Measure | Description | Time Frame |
|---|---|---|
| Comparison of SureCALL® and TOCO Detection of Contraction Events, as Compared to the IUPC, as Identified by Readers | The presence of contractions measured by the SureCALL®, the presence of contractions measured by the TOCO, and the presence of contractions measured by the IUPC were determined by independent Readers. The Odds Ratio of SureCALL® contractions to IUPC contractions was calculated, and the Odd Ratio of TOCO contractions to IUPC contractions was calculated. Reader Correspondence was determined by a General Linear Mixed Model. | 9 - 42 Minutes |
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Inclusion Criteria:
Exclusion Criteria:
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Women in labor with uncomplicated singleton pregnancies and IUPC indicated with membranes ruptured and sufficient cervical dilation.
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| Name | Affiliation | Role |
|---|---|---|
| Timothy B Waterhouse, MD | Reproductive Research Technologies, LP | Principal Investigator |
| 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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| ID | Title | Description |
|---|---|---|
| FG000 | Pregnant, In Labor | Monitored simultaneously by SureCALL®, TOCO, and IUPC |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregnant, In Labor | Monitored simultaneously by SureCALL®, TOCO, and IUPC |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Comparison of SureCALL® and TOCO Detection of Contraction Events, as Compared to the IUPC, as Identified by Readers | The presence of contractions measured by the SureCALL®, the presence of contractions measured by the TOCO, and the presence of contractions measured by the IUPC were determined by independent Readers. The Odds Ratio of SureCALL® contractions to IUPC contractions was calculated, and the Odd Ratio of TOCO contractions to IUPC contractions was calculated. Reader Correspondence was determined by a General Linear Mixed Model. | Posted | Jan 2011 | Number | 95% Confidence Interval | Odds Ratio | 9 - 42 Minutes |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pregnant, In Labor | Monitored simultaneously by SureCALL®, TOCO, and IUPC |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jack McCrary | Reproductive Research Technologies, LP | 7136800200 | jmc@innovalp.com |
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| Philadelphia |
| Pennsylvania |
| 19102 |
| United States |
| University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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PIs may publish or present results of the study after the expiration of 12 months from completion. Publications or presentations are subject to the protection of confidential information or patentable information.