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This measurement 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 measurement 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:
Using IUPC as the "gold standard", this study methodology allowed a three way comparison for evaluating how well the SureCALL® system performed compared to the TOCO technology.
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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 | Contraction timing as measured by the SureCALL® and contraction timing as measured by the TOCO, both compared to the contraction timing as measured by the IUPC gold standard. The contraction timing values of SureCALL® and TOCO were then compared. | 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 | 85004 | 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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| Philadelphia |
| Pennsylvania |
| 19102 |
| United States |
| University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregnant, In Labor | Monitored simultaneously by SureCALL®, TOCO, and IUPC |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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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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| Region of Enrollment | Number | participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Comparison of SureCALL® and TOCO Detection of Contraction Events, as Compared to the IUPC | Contraction timing as measured by the SureCALL® and contraction timing as measured by the TOCO, both compared to the contraction timing as measured by the IUPC gold standard. The contraction timing values of SureCALL® and TOCO were then compared. | Posted | Jan 2011 | Mean | Standard Deviation | Seconds | 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 | 0 | 20 | 0 | 20 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jack McCrary | Reproductive Research Technologies, LP | 7136800200 | jmc@innovalp.com |
| Mixed Models Analysis |
| 0.1676 |
| 95 |
| No |
| Superiority or Other |