CompletedNot Applicable

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

United States129 participantsStarted 2024-05-07

Plain-language 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

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Reference range intervals for measurement of Clot Stability to Lysis (CSL) parameter

Timeframe: Baseline, determined from a single blood draw

Reference range intervals for measurement of Fibrinogen Contribution (FCS) parameter

Timeframe: Baseline, determined from a single blood draw

Reference range intervals for measurement of Platelet Contribution (PCS) parameter

Timeframe: Baseline, determined from a single blood draw

Reference range intervals for measurement of Clot Stiffness (CS) parameter

Timeframe: Baseline, determined from a single blood draw

Reference range intervals for measurement of Clot Time (CT) parameter

Timeframe: Baseline, determined from a single blood draw

Trial details

NCT IDNCT06415760

SponsorHemoSonics LLC

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-04-01

View on ClinicalTrials.gov More Obstetric Hemostasis trials

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Reference range intervals for measurement of Clot Stability to Lysis (CSL) parameter

Timeframe: Baseline, determined from a single blood draw

Reference range intervals for measurement of Fibrinogen Contribution (FCS) parameter

Timeframe: Baseline, determined from a single blood draw

Reference range intervals for measurement of Platelet Contribution (PCS) parameter

Timeframe: Baseline, determined from a single blood draw

Reference range intervals for measurement of Clot Stiffness (CS) parameter

Timeframe: Baseline, determined from a single blood draw

Reference range intervals for measurement of Clot Time (CT) parameter

Timeframe: Baseline, determined from a single blood draw