Measuring fibrinogen levels in severe postpartum hemorrhage
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
This study is testing a new bedside device to see if it can accurately measure fibrinogen levels in women who have heavy bleeding after giving birth, to help improve their care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 2 sites (Paris and 1 other locations) |
| Trial ID | NCT06255002 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the concordance between the qLabs®FIB Analyzer and the conventional Clauss fibrinogen assay in measuring fibrinogen levels in patients experiencing severe postpartum hemorrhage. The study focuses on adult patients who have experienced significant bleeding (greater than 1000 ml) within 24 hours postpartum. By utilizing a rapid testing method available at the bedside, the study seeks to optimize the management of severe postpartum hemorrhage and improve patient outcomes. The hypothesis is that the qLabs®FIB Monitoring system will provide reliable fibrinogen measurements that can help identify patients at risk of severe complications.
Who should consider this trial
Good fit: Ideal candidates for this study are adult women who have experienced severe postpartum hemorrhage defined as bleeding greater than 1000 ml within 24 hours after delivery.
Not a fit: Patients who may not benefit from this study include those with a constitutional fibrinogen deficiency or those who oppose participation.
Why it matters
Potential benefit: If successful, this study could lead to improved early diagnosis and management of severe postpartum hemorrhage, potentially reducing maternal mortality rates.
How similar studies have performed: While this approach is novel in the context of severe postpartum hemorrhage, similar rapid testing methods have shown promise in other clinical settings.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris and 1 other locations
- Hôpital Cochin Maternité Port Royal — Paris, France (Recruiting)
- Hôpital Necker-Enfants Malades — Paris, France (Recruiting)
Study contacts
- Principal investigator: Hawa KEITA-MEYER, MD-PhD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Hawa KEITA-MEYER, MD-PhD
- Email: hawa.keita@aphp.fr
- Phone: 1 44 49 42 06
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.