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This study will determine reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge in the last trimester of non-laboring pregnant women with an uncomplicated pregnancy
During pregnancy, there is a progressive shift of hemostasis toward a hypercoagulable state that is protective against postpartum hemorrhage. To assess the clinical utility of the Quantra System in high-risk OB patients during delivery, it is important to understand how the normal physiological changes of pregnancy impact Quantra results. This study will determine reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge in the last trimester of non-laboring pregnant women with an uncomplicated pregnancy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obstetric Patients | Adult pregnant women in their third trimester of prenancy with no prenatal risk factors and an uncomplicated pregnancy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quantra System | Diagnostic Test | Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reference range intervals for measurement of Clot Stability to Lysis (CSL) parameter | Reference range intervals for CSL for pregnant women in third trimester | Baseline, determined from a single blood draw |
| Reference range intervals for measurement of Fibrinogen Contribution (FCS) parameter | Reference range intervals for FCS for pregnant women in third trimester | Baseline, determined from a single blood draw |
| Reference range intervals for measurement of Platelet Contribution (PCS) parameter | Reference range intervals for PCS for pregnant women in third trimester | Baseline, determined from a single blood draw |
| Reference range intervals for measurement of Clot Stiffness (CS) parameter | Reference range intervals for CS for pregnant women in third trimester | Baseline, determined from a single blood draw |
| Reference range intervals for measurement of Clot Time (CT) parameter | Reference range intervals for CT for pregnant women in third trimester | Baseline, determined from a single blood draw |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant women
Adult pregnant women 18 years of age or older in their third trimester of pregnancy with no prenatal risk factors and an uncomplicated pregnancy.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida Medicine | Gainesville | Florida | 32611 | United States | ||
| Unified Womens Clinical Research |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Raleigh |
| North Carolina |
| 27612 |
| United States |
| Unified Womens Clinical Research | Winston-Salem | North Carolina | 27103 | United States |