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

NCT ID: NCT06255002

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-03
• Study Completion Date: 2026-04-30

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.

Conditions

Postpartum Hemorrhage

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients

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).

Fibrinogen concentration by the qLabs®FIB Monitoring system

Intervention Type: BIOLOGICAL

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.

Interventions

Fibrinogen 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.

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hawa KEITA-MEYER, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Marc SAMAMA, MD-PhD

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Cochin Maternité Port Royal

Paris, , France

Site Status: RECRUITING

Hôpital Necker-Enfants Malades

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Hawa KEITA-MEYER, MD-PhD

Role: CONTACT

hawa.keita@aphp.fr

1 44 49 42 06 ext. +33

Hélène Morel

Role: CONTACT

helene.morel@aphp.fr

1 71 19 63 46 ext. +33

Facility Contacts

Marc SAMAMA, MD-PhD

Role: primary

marc.samama@aphp.fr

1 58 41 14 87 ext. +33

Hawa KEITA-MEYER, MD-PhD

Role: primary

hawa.keita@aphp.fr

1 44 49 42 06 ext. +33

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Other Identifiers

APHP231640

Identifier Type: -

Identifier Source: org_study_id