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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 preterm and term pregnant patients.
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 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:
Subjects did not recieve any interventions as a part of this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Comparison of SureCALL® and Tocodynamometer Detection of Contraction Event Timing | Time Stamps of the Peaks of Corresponding Contractions | 9 - 41 Minutes |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant women with uncomplicated singleton pregnancies
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| Name | Affiliation | Role |
|---|---|---|
| Timothy B Waterhouse, MD | Reproductive Research Technologies, LP | Study Director |
| 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, Preterm, In Labor | Pregnant preterm women independently determined to be in labor. |
| FG001 | Pregnant, Preterm, Non Labor | Pregnant preterm women independently determined to not be in labor. |
| FG002 | Pregnant, Term, Non Labor | Pregnant term women independently determined to be in labor. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregnant | The study focused on recruiting laboring preterm patients, nonlaboring preterm patients, and nonlaboring term patients. |
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| 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 Tocodynamometer Detection of Contraction Event Timing | Time Stamps of the Peaks of Corresponding Contractions | Posted | Mean | Standard Deviation | Seconds | 9 - 41 Minutes |
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Adverse events were reported from the date of each patient's enrollment through delivery.
There were no interventions as a part of the study and no adverse events related to the study reported.
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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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jack McCrary | Reproductive Research Technologies, LP | 7136800200 | jmc@innovalp.com |
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| Philadelphia |
| Pennsylvania |
| 19101 |
| United States |
| Southeast Texas OB/GYN Associates | Beaumont | Texas | 77702 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
| Woman's Hospital of Texas | Houston | Texas | 77054 | United States |
| Participants |
|
| 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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|
| 0 |
| 30 |
| 0 |
| 30 |
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.