Reference Range Study for the Quantra System With the QStat Cartridge in Obstetric Patients

HemoSonics LLC129 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

129

Conditions

Obstetric Hemostasis Coagulation

Interventions

Quantra SystemDIAGNOSTIC_TEST

Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subject is female, age 18 to 45 years old. * Subject is pregnant with a single fetus and duration of pregnancy is \>28weeks * Subject is willing to participate and has provided informed consent. Exclusion Criteria: * Subject has a history of a coagulation disorder (including excessive bleeding, thrombosis, VWD, or any factor deficiencies). * Subject has taken medications known to alter coagulation during pregnancy including heparin, warfarin/Coumadin®, antiplatelet drugs including Plavix® or aspirin at a dose greater than 81 mg/day, Xarelto® or Eliquis®, or other anticoagulants. * Subject has experienced one or more complications during pregnancy such as gestational diabetes, high blood pressure, pre-eclampsia or eclampsia, hypovolemia or pre-term labor. * Subject had a blood transfusion during pregnancy. * Subject has a history of smoking/vaping during pregnancy

Locations (3)

University of Florida Medicine

Gainesville, Florida, United States

Unified Womens Clinical Research

Raleigh, North Carolina, United States

Unified Womens Clinical Research

Winston-Salem, North Carolina, United States