Coagulation, Obstetric Hemostasis
Conditions
Keywords
Quantra, Viscoelastic testing, Coagulation
Brief summary
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
Detailed description
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.
Interventions
DIAGNOSTIC_TESTQuantra System
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care
Sponsors
HemoSonics LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reference range intervals for measurement of Clot Stability to Lysis (CSL) parameter | Baseline, determined from a single blood draw | Reference range intervals for CSL for pregnant women in third trimester |
| Reference range intervals for measurement of Fibrinogen Contribution (FCS) parameter | Baseline, determined from a single blood draw | Reference range intervals for FCS for pregnant women in third trimester |
| Reference range intervals for measurement of Platelet Contribution (PCS) parameter | Baseline, determined from a single blood draw | Reference range intervals for PCS for pregnant women in third trimester |
| Reference range intervals for measurement of Clot Stiffness (CS) parameter | Baseline, determined from a single blood draw | Reference range intervals for CS for pregnant women in third trimester |
| Reference range intervals for measurement of Clot Time (CT) parameter | Baseline, determined from a single blood draw | Reference range intervals for CT for pregnant women in third trimester |
Countries
United States
Outcome results
None listed