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A clinical study designed to validate the safety and performance of the TrueLaborâ„¢ device in monitoring labor vs. current standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort | Women in active labor following rupture of membranes and placement of an IUPC and/or FSE for obstetric indications |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TrueLabor | Device | Non invasive monitoring device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety, comparative performance, and reliability of the TrueLaborâ„¢ system for Fetal Heart Rate | This will be performed using a Performance Goal | Through labor, until delivery |
| Safety, comparative performance, and reliability of the TrueLaborâ„¢ system for Uterine Activity | This will be performed using a Performance Goal | Through labor, until delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of BMI (weight in Kg, height in meters will be combined to report BMI in kg/m2) | Effect of BMI on the performance measures | Through labor, until delivery |
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Inclusion Criteria:
Exclusion Criteria:
Women in active labor
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Women (age>18 y/o) in active labor following rupture of membranes and placement of an IUPC and/or FSE.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ascension Illinois Saint Alexius Residency Program in Obstetrics and Gynecology | Hoffman Estates | Illinois | 60169 | United States | ||
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| Label | URL |
|---|---|
| OB Tools website | View source |
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| Montefiore Medical Center |
| The Bronx |
| New York |
| 10467 |
| United States |
| Meir Medical Center | Kfar Saba | Israel |