Improving Management of Post-partum Haemorrhage With Quantra® System

NCT05336838 | Unknown

• 1 other identifier: RECHMPL21_0729
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Post Partum Haemorrhage

Keywords

Post partum haemorrhage; Bleeding; Labour; Vaginal delivery; Caesarean section

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• Comparison of Quantra Clot Time result to Standard Kaolin Clotting time result

  When post partum haemorrhage occurred, within 24 hours after delivery

• Comparison of Platelet Clot Stiffness result to standard platelet count result

  When post partum haemorrhage occurred, within 24 hours after delivery

• Rate of satisfaction of anesthetist in charge of patient assessed by Lickert scale

  When post partum haemorrhage occurred, within 24 hours after delivery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women ≥ 18 years old experiencing post partum haemorrhage ≥ 500 mL

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

MeSH Terms

Conditions

Postpartum Hemorrhage; Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jessie Grenié, MD

CONTACT

00330467336472; j-grenie@chu-montpellier.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 20, 2022
• Study Start: May 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: April 20, 2022

Record last verified: 2022-04