Improving Management of Post-partum Haemorrhage With Quantra® System

• Conditions: Post Partum Haemorrhage

• Registration Number: NCT05336838
• Lead Sponsor: University Hospital, Montpellier

Brief 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.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-23
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-13
• Last Update Submitted: 2022-04-13
• Study First Posted: 2022-04-20
• Last Update Posted: 2022-04-20
• Study Start: 2022-05-01
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Women ≥ 18 years old Experiencing post partum haemorrhage ≥ 500 mL Within 24 hours after delivery

Exclusion Criteria

• Previous anemia ≤ 7g/dL
• Known bleeding disorders
• Ongoing antiplatelets treatment
• Ongoing anticoagulant treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of delay in obtaining Quantra Fibrinogen Clot Stiffness result to standard fibrinogen level result	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

Secondary Outcome Measures

Name	Time	Method
Rate of satisfaction of anesthetist in charge of patient assessed by Lickert scale	When post partum haemorrhage occurred, within 24 hours after delivery	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
Comparison of Quantra Clot Time result to Standard Kaolin Clotting time result	When post partum haemorrhage occurred, within 24 hours after delivery	Coagulation function assessed by Quantra and standard coagulation tests
Comparison of level of fibrinogen assessed by Quantra Fibrinogen Clot Stiffness to level of fibrinogen assessed by standard coagulation test	When post partum haemorrhage occurred, within 24 hours after delivery	Fibrinogen level assessed by Quantra and standard coagulation tests
Comparison of Platelet Clot Stiffness result to standard platelet count result	When post partum haemorrhage occurred, within 24 hours after delivery	Platelet function assessed by Quantra and standard platelet count.