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

HemoSonics

Status: Invitation-only

Conditions: Coagulation; Obstetric Hemostasis

Treatments: Diagnostic Test: Quantra System

Study type: Observational

Funder types: Industry

Identifiers

NCT06415760

HEMCS-047

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

150 participants in 1 patient group

Obstetric Patients

Description:

Adult pregnant women in their third trimester of prenancy with no prenatal risk factors and an uncomplicated pregnancy.

Treatment:

Diagnostic Test: Quantra System