Clinical trial NCT06255002: 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
Official title: 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: a Prospective Multicenter Non-interventional Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Postpartum Hemorrhage
Keywords: Severe postpartum haemorrhage
Fibrinogen concentration
qLabs®FIB Monitoring system
Clauss fibrinogen assay
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients giving birth in the two type 3 maternity wards of the Paris Center University Hospital Group : Necker-Enfants Malades et Cochin Port Royal (APHP) and with severe postpartum hemorrhage.

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.

Eligibility criteria: 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).

Exclusion Criteria:

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

Primary outcomes:
measure: Agreement between fibrinogen measurement by qLabs®FIB and by the Clauss method
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Evaluation of the ease of use of qLabs®FIB by the anesthesia team
timeFrame: Through study completion, an average of 1 year
measure: Evaluation of the time taken to obtain the fibrinogen concentration using the 2 methods
timeFrame: Through study completion, an average of 1 year
measure: Evaluation of measurement failure by qLabs®FIB
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Cochin Maternité Port Royal
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Hawa KEITA-MEYER, MD-PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Marc SAMAMA, MD-PhD
role: STUDY_DIRECTOR
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