Postpartum Hemorrhage
Conditions
Keywords
Severe postpartum haemorrhage, Fibrinogen concentration, qLabs®FIB Monitoring system, Clauss fibrinogen assay
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.
Interventions
BIOLOGICALFibrinogen concentration by the qLabs®FIB Monitoring system
A drop of blood (\~15 μL) is taken from the blood sample for the complete haemostasis assessment (prothrombin level, activated partial thromboplastin time, fibrinogen). This assessment is part of the usual management of severe postpartum haemorrhage. It is carried out urgently in the hospital's medical biology laboratory at the start of treatment (T1) and during or at the end of treatment of the haemorrhage (T2). This drop of blood will allow the measurement of the fibrinogen concentration by the qLabs®FIB Monitoring system for the study at these two times.
Sponsors
Assistance Publique - Hôpitaux de Paris
URC-CIC Paris Descartes Necker Cochin
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORHawa KEITA-MEYER, MD-PhD
Assistance Publique - Hôpitaux de Paris
STUDY_DIRECTORMarc SAMAMA, MD-PhD
Assistance Publique - Hôpitaux de Paris
Outcome results
None listed