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Search / 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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Feb 9, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Severe Postpartum Haemorrhage Fibrinogen Concentration Q Labs®Fib Monitoring System Clauss Fibrinogen Assay

ClinConnect Summary

This clinical trial is looking at a new way to measure a substance called fibrinogen in women who are experiencing severe postpartum hemorrhage, which is heavy bleeding after childbirth. In France, a significant number of women face this issue, and low levels of fibrinogen can indicate a more serious condition. The researchers want to see if a quick test called the qLabs®FIB analyzer, which can be used right in the delivery room, gives similar results to the traditional laboratory method. By measuring fibrinogen levels quickly, healthcare providers may be able to manage severe bleeding more effectively, potentially preventing complications.

To participate in this study, women who have experienced severe postpartum hemorrhage (bleeding more than 1000 ml within 24 hours after giving birth) may be eligible. Participants will need to agree to take part in the study and cannot have certain conditions, like a specific type of blood problem or legal restrictions. If you join the trial, you can expect to have your fibrinogen levels tested using the new quick method and help researchers understand if it can improve care for women facing severe bleeding after delivery.

Gender

FEMALE

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

About Assistance Publique Hôpitaux De Paris

Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.

Locations

Paris, , France

Paris, , France

Patients applied

0 patients applied

Trial Officials

Hawa KEITA-MEYER, MD-PhD

Principal Investigator

Assistance Publique - Hôpitaux de Paris

Marc SAMAMA, MD-PhD

Study Director

Assistance Publique - Hôpitaux de Paris

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported