Obstetric HemostasisNCT06415760
Reference Range Study for the Quantra System With the QStat Cartridge in Obstetric Patients
An observational study of Obstetric Hemostasis and Coagulation, run by HemoSonics LLC at 3 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obstetric Hemostasis, Coagulation
- What is being tested?
- Quantra System
- How many people
- 129 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 May 2024to 1 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Adult pregnant women 18 years of age or older in their third trimester of pregnancy with no prenatal risk factors and an uncomplicated pregnancy.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
United States3 sites
University of Florida Medicine
Gainesville, Florida, 32611
Unified Womens Clinical Research
Raleigh, North Carolina, 27612
Unified Womens Clinical Research
Winston-Salem, North Carolina, 27103
About this study
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
Read the 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.
- Conditions
- Obstetric Hemostasis, Coagulation
- Being tested
- Quantra System
- Keywords
- Quantra, Viscoelastic testing, Coagulation
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantra SystemDiagnostic test
Also called QStat Cartridge
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care
| Study group | Role | What they receive |
|---|---|---|
| Obstetric Patients | Adult pregnant women in their third trimester of prenancy with no prenatal risk factors and an uncomplicated pregnancy. Receives: Diagnostic Test: Quantra System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reference range intervals for measurement of Clot Stability to Lysis (CSL) parameter
Reference range intervals for CSL for pregnant women in third trimester
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, determined from a single blood draw
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start7 May 2024
- Primary completion1 Apr 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric HemostasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- HemoSonics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06415760
- Sponsor's protocol ID
- HEMCS-047
- Status last verified
- Jul 2025
- First submitted
- 10 May 2024
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reference Range Study for the Quantra System With the QStat Cartridge in Obstetric Patients
- ClinicalTrials.gov ID
- NCT06415760
- Acronym / sponsor ID
- HEMCS-047
- Conditions
- Obstetric Hemostasis, Coagulation
- Keywords
- Quantra, Viscoelastic testing, Coagulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- HemoSonics LLCIndustry (pharma, biotech, devices)
- Study start
- 7 May 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obstetric Patients | – | Diagnostic Test: Quantra SystemAdult pregnant women in their third trimester of prenancy with no prenatal risk factors and an uncomplicated pregnancy. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adult pregnant women 18 years of age or older in their third trimester of pregnancy with no prenatal risk factors and an uncomplicated pregnancy.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantra SystemAlso: QStat CartridgeDiagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care | Diagnostic test | Obstetric Patients |
Primary outcome
Reference range intervals for measurement of Clot Stability to Lysis (CSL) parameter
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, determined from a single blood draw
Reference range intervals for CT for pregnant women in third trimester
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstetric Hemostasis and Coagulation, run by HemoSonics LLC at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reference range intervals for measurement of Clot Stability to Lysis (CSL) parameter (time frame: Baseline, determined from a single blood draw). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.