Improving Management of Post-partum Haemorrhage With Quantra® System

Post Partum Haemorrhage Clinical Trial

— Quantralab  

Official title:

Use of Quantra® System in Clinical Practice to Improve Management of Post-partum Haemorrhage : a Prospective Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05336838
• Other study ID #: RECHMPL21_0729
• Status: Not yet recruiting
• Start date: May 1, 2022
• Est. completion date: May 1, 2023

Study information

• Verified date: April 2022
• Source: University Hospital, Montpellier
• Contact: Jessie Grenié, MD
• Phone: 00330467336472
• Email: j-grenie[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Post Partum Haemorrhage
• Postpartum Hemorrhage

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	When post partum haemorrhage occurred, within 24 hours after delivery
Secondary	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	When post partum haemorrhage occurred, within 24 hours after delivery
Secondary	Comparison of Quantra Clot Time result to Standard Kaolin Clotting time result	Coagulation function assessed by Quantra and standard coagulation tests	When post partum haemorrhage occurred, within 24 hours after delivery
Secondary	Comparison of Platelet Clot Stiffness result to standard platelet count result	Platelet function assessed by Quantra and standard platelet count.	When post partum haemorrhage occurred, within 24 hours after delivery
Secondary	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	When post partum haemorrhage occurred, within 24 hours after delivery