Concordance Between the Measurement of Whole Blood Fibrinogen by the QLabs®FIB Analyzer and Its Measurement by Conventional Method (Clauss Fibrinogen) in the Context of Severe Postpartum Haemorrhage

Recruiting

• Conditions: Postpartum Hemorrhage
• Interventions: Biological: Fibrinogen concentration by the qLabs®FIB Monitoring system

• Registration Number: NCT06255002
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

In France in 2021, 11.6% of deliveries were complicated by a postpartum haemorrhage (PPH), including 3.0% by severe PPH (the bleeding volume exceeds 1000 ml). Severe PPH is the 5th cause of maternal death (8.4% or 1.2 deaths per 100,000 live births). These deaths were considered preventable in 90% of cases. A plasma fibrinogen concentration below 2 g/L is considered as a critical threshold which constitutes a marker of severity of PPH and is significantly associated with the occurrence of severe PPH. Measuring the concentration of fibrinogen using a rapid test, simple to perform and interpret, available in the delivery room could optimize the management of severe PPH. The qLabs®FIB analyzer distributed by the Stago Biocare laboratory for the rapid determination of the fibrinogen concentration at the patient's bedside could meet this objective.

Detailed Description

In France in 2021, 11.6% of deliveries were complicated by postpartum hemorrhage (PPH), including 3.0% by severe PPH (the bleeding volume exceeds 1000 ml). Severe PPH is the 5th cause of maternal death (8.4% or 1.2 deaths per 100,000 live births). These deaths were considered preventable in 90% of cases. A plasma fibrinogen concentration below 2 g/L is considered as a critical threshold which constitutes a marker of severity of PPH and is significantly associated with the occurrence of severe PPH. Measuring the concentration of fibrinogen using a rapid test, simple to perform and interpret, available in the delivery room could optimize the management of severe PPH. The qLabs®FIB analyzer distributed by Stago Biocare laboratory for the rapid determination of the fibrinogen concentration at the patient's bedside could meet this objective.

The hypothesis of the study is a concordance between the measurement of fibrinogen by the qLabs®FIB Monitoring system and by the Clauss fibrinogen assay in laboratory to identify patients with a fibrinogen level \< 2 g/L.

The prospects are to provide an easy-to-use delocalized biology tool for early diagnosis of a fibrinogen concentration \< 2g predictive of an unfavorable evolution in the context of severe PPH.

Study Timeline

• Study First Submitted: 2023-12-05
• Study First Submitted QC: 2024-02-09
• Study First Posted: 2024-02-12
• Study Start: 2024-06-03
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-24
• Last Update Posted: 2024-10-28
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

Adult patients having been informed of the study and not having objected to their participation and treated for severe postpartum haemorrhage defined as bleeding greater than 1000 ml within 24 hours postpartum, whatever the route delivery (vaginal route and caesarean section).

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Exclusion Criteria

• Opposition to participation in the study
• Presence of a constitutional fibrinogen deficiency
• Patients under guardianship or curatorship

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Fibrinogen concentration by the qLabs®FIB Monitoring system	Patients giving birth in the Cochin Port Royal and Necker Enfants Malades (APHP) maternity units and cared for severe postpartum haemorrhage defined as bleeding greater than 1000 ml within 24 hours of postpartum, regardless of the route of delivery (vaginal delivery and cesarean section).

Primary Outcome Measures

Name	Time	Method
Agreement between fibrinogen measurement by qLabs®FIB and by the Clauss method	Through study completion, an average of 1 year	Calculation of the average bias and the 95% limits of agreement between the measurement of qLabs®FIB fibrinogen in the delivery room and Clauss fibrinogen at the medical biology laboratory using the Bland and Altman graphic method. A difference of 0.1 g between the two techniques will be considered acceptable to identify patients with a fibrinogen level \< 2 g/L.

Secondary Outcome Measures

Name	Time	Method
Evaluation of the ease of use of qLabs®FIB by the anesthesia team	Through study completion, an average of 1 year	Ease of use of the qLabs®FIB assessed by a numerical scale between 0-10 by the anesthesia team.
Evaluation of the time taken to obtain the fibrinogen concentration using the 2 methods	Through study completion, an average of 1 year	Time to obtain the fibrinogen result with the qLabs®FIB and the Clauss method at the medical biology laboratory using the emergency circuit proposed by the laboratory.
Evaluation of measurement failure by qLabs®FIB	Through study completion, an average of 1 year	Number of failed fibrinogen measurements with qLabs®FIB defined as the absence of results returned by the monitor.

Trial Locations

Locations (2)

Hôpital Cochin Maternité Port Royal; 🇫🇷 Paris, France

Hôpital Necker-Enfants Malades; 🇫🇷 Paris, France