Actively Recruiting

Age: 18Years +
FEMALE
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

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-09-12

70

Participants Needed

2

Research Sites

95 weeks

Total Duration

On this page

Sponsors

A

Assistance Publique - Hôpitaux de Paris

Lead Sponsor

U

URC-CIC Paris Descartes Necker Cochin

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients treated for severe postpartum haemorrhage defined as bleeding greater than 1000 ml within 24 hours after delivery
  • Patients informed about the study who have not opposed participation
  • Delivery by any route (vaginal or caesarean)
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Hôpital Cochin Maternité Port Royal

Paris, France, 75014

Actively Recruiting

2

Hôpital Necker-Enfants Malades

Paris, France, 75015

Actively Recruiting

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Research Team

H

Hawa KEITA-MEYER, MD-PhD

CONTACT

H

Hélène Morel

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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