Post Partum HaemorrhageQuantralabNCT05336838
Improving Management of Post-partum Haemorrhage With Quantra® System
An observational study of Post Partum Haemorrhage, run by University Hospital, Montpellier.
Trial summary
Post partum haemorrhage is a concerning situation in maternity wards, though it is not the first cause of maternal mortality anymore. It has been already shown that low fibrinogen level is a major predictive factor of massive bleeding after delivery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post Partum Haemorrhage
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 1 May 2023
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women ≥ 18 years old experiencing post partum haemorrhage ≥ 500 mL
Who may be able to join
- Women ≥ 18 years old Experiencing post partum haemorrhage ≥ 500 mL Within 24 hours after delivery
Who cannot join
- Previous anemia ≤ 7g/dL
- Known bleeding disorders
- Ongoing antiplatelets treatment
- Ongoing anticoagulant treatment
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Use of Quantra® System in Clinical Practice to Improve Management of Post-partum Haemorrhage : a Prospective Study
Post partum haemorrhage is a concerning situation in maternity wards, though it is not the first cause of maternal mortality anymore.
It has been already shown that low fibrinogen level is a major predictive factor of massive bleeding after delivery.
In this situation, the early knowledge of fibrinogen level could enhance care of women experiencing post partum haemorrhage.
In a cohort of women suffering from post partum haemorrhage, this study will evaluate whether assessing fibrinogen level would be faster using the Quantra® system than the standard coagulation test.
- Conditions
- Post Partum Haemorrhage
- Keywords
- Post partum haemorrhage, Bleeding, Labour, Vaginal delivery, Caesarean section
- Medical subject headings
- Postpartum Hemorrhage, Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of delay in obtaining Quantra Fibrinogen Clot Stiffness result to standard fibrinogen level result
Comparison of delay in obtaining Quantra Fibrinogen Clot Stiffness result to standard fibrinogen level result
Measured: When post partum haemorrhage occurred, within 24 hours after delivery
Secondary outcomes (4)
Comparison of level of fibrinogen assessed by Quantra Fibrinogen Clot Stiffness to level of fibrinogen assessed by standard coagulation test
Fibrinogen level assessed by Quantra and standard coagulation tests
Measured: When post partum haemorrhage occurred, within 24 hours after delivery
Comparison of Quantra Clot Time result to Standard Kaolin Clotting time result
Coagulation function assessed by Quantra and standard coagulation tests
Measured: When post partum haemorrhage occurred, within 24 hours after delivery
Comparison of Platelet Clot Stiffness result to standard platelet count result
Platelet function assessed by Quantra and standard platelet count.
Measured: When post partum haemorrhage occurred, within 24 hours after delivery
Rate of satisfaction of anesthetist in charge of patient assessed by Lickert scale
Rate of satisfaction of anesthetist in charge of patient assessed by Lickert scale [1-Strongly disagree ; 2-Disagree ; 3-Neither agree nor disagree ; 4-Agree ; 5-Strongly agree
Measured: When post partum haemorrhage occurred, within 24 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start1 May 2022 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Partum HaemorrhageStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GRENIE, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05336838
- Sponsor's protocol ID
- RECHMPL21_0729
- Acronym
- Quantralab
- Status last verified
- Apr 2022
- First submitted
- 23 Mar 2022
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Quantra® System in Clinical Practice to Improve Management of Post-partum Haemorrhage : a Prospective Study
- ClinicalTrials.gov ID
- NCT05336838
- Acronym / sponsor ID
- Quantralab / RECHMPL21_0729
- Conditions
- Post Partum Haemorrhage
- Keywords
- Post partum haemorrhage, Bleeding, Labour, Vaginal delivery, Caesarean section
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 20 Apr 2022 (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.
Post partum haemorrhage is a concerning situation in maternity wards, though it is not the first cause of maternal mortality anymore.
It has been already shown that low fibrinogen level is a major predictive factor of massive bleeding after delivery.
In this situation, the early knowledge of fibrinogen level could enhance care of women experiencing post partum haemorrhage.
In a cohort of women suffering from post partum haemorrhage, this study will evaluate whether assessing fibrinogen level would be faster using the Quantra® system than the standard coagulation test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women ≥ 18 years old experiencing post partum haemorrhage ≥ 500 mL
Key inclusion criteria (1 listed)
- Women ≥ 18 years old Experiencing post partum haemorrhage ≥ 500 mL Within 24 hours after delivery
Key exclusion criteria (4 listed)
- Previous anemia ≤ 7g/dL
- Known bleeding disorders
- Ongoing antiplatelets treatment
- Ongoing anticoagulant treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of delay in obtaining Quantra Fibrinogen Clot Stiffness result to standard fibrinogen level result
Time frame: When post partum haemorrhage occurred, within 24 hours after delivery
Comparison of delay in obtaining Quantra Fibrinogen Clot Stiffness result to standard fibrinogen level result
4 secondary outcomes
Comparison of level of fibrinogen assessed by Quantra Fibrinogen Clot Stiffness to level of fibrinogen assessed by standard coagulation test
Time frame: When post partum haemorrhage occurred, within 24 hours after delivery
Comparison of Quantra Clot Time result to Standard Kaolin Clotting time result
Time frame: When post partum haemorrhage occurred, within 24 hours after delivery
Comparison of Platelet Clot Stiffness result to standard platelet count result
Time frame: When post partum haemorrhage occurred, within 24 hours after delivery
Rate of satisfaction of anesthetist in charge of patient assessed by Lickert scale
Time frame: When post partum haemorrhage occurred, within 24 hours after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Partum Haemorrhage, run by University Hospital, Montpellier.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jessie Grenié, MD (00330467336472, j-grenie@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of delay in obtaining Quantra Fibrinogen Clot Stiffness result to standard fibrinogen level result (time frame: When post partum haemorrhage occurred, within 24 hours after delivery). 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 20 Apr 2022.