Postpartum HemorrhageFIB-HPPSNCT06255002
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
An observational study of Postpartum Hemorrhage, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Fibrinogen concentration by the qLabs®FIB Monitoring system
- How many people
- 70 participants
- Where
- 2 sitesFrance
- Study dates
- 3 Jun 2024to 2 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study population: Patients giving birth in the two type 3 maternity wards of the Paris Center University Hospital Group : Necker-Enfants Malades et Cochin Port Royal (APHP) and with severe postpartum hemorrhage.
Who may be able to join
- 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).
Who cannot join
- Opposition to participation in the study
- Presence of a constitutional fibrinogen deficiency
- Patients under guardianship or curatorship
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Cochin Maternité Port Royal
Paris, 75014
Hôpital Necker-Enfants Malades
Paris, 75015
About this study
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: a Prospective Multicenter Non-interventional Study
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.
Read the 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
- Being tested
- Fibrinogen concentration by the qLabs®FIB Monitoring system
- Keywords
- Severe postpartum haemorrhage, Fibrinogen concentration, qLabs®FIB Monitoring system, Clauss fibrinogen assay
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrinogen concentration by the qLabs®FIB Monitoring systemBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Biological: Fibrinogen concentration by the qLabs®FIB Monitoring system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between fibrinogen measurement by qLabs®FIB and by the Clauss method
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.
Measured: Through study completion, an average of 1 year
Secondary outcomes (3)
Evaluation of the ease of use of qLabs®FIB by the anesthesia team
Ease of use of the qLabs®FIB assessed by a numerical scale between 0-10 by the anesthesia team.
Measured: Through study completion, an average of 1 year
Evaluation of the time taken to obtain the fibrinogen concentration using the 2 methods
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.
Measured: Through study completion, an average of 1 year
Evaluation of measurement failure by qLabs®FIB
Number of failed fibrinogen measurements with qLabs®FIB defined as the absence of results returned by the monitor.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start3 Jun 2024
- Primary completion2 Mar 2026
- Study completion2 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Hawa KEITA-MEYER, MD-PhD, Principal investigator, Assistance Publique - Hôpitaux de ParisMarc SAMAMA, MD-PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255002
- Sponsor's protocol ID
- APHP231640
- Acronym
- FIB-HPPS
- Status last verified
- May 2026
- First submitted
- 5 Dec 2023
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sentilhes L, Vayssiere C, Deneux-Tharaux C, Aya AG, Bayoumeu F, Bonnet MP, Djoudi R, Dolley P, Dreyfus M, Ducroux-Schouwey C, Dupont C, Francois A, Gallot D, Haumonte JB, Huissoud C, Kayem G, Keita H, Langer B, Mignon A, Morel O, Parant O, Pelage JP, Phan E, Rossignol M, Tessier V, Mercier FJ, Goffinet F. Postpartum hemorrhage: guidelines for clinical practice from the French College of Gynaecologists and Obstetricians (CNGOF): in collaboration with the French Society of Anesthesiology and Intensive Care (SFAR). Eur J Obstet Gynecol Reprod Biol. 2016 Mar;198:12-21. doi: 10.1016/j.ejogrb.2015.12.012. Epub 2015 Dec 21.
PubMed 26773243Blondel B et al. Enquête nationale périnatale 2021
Saucedo M, Tessier V, Leroux S, Almeras A, Deneux-Tharaux C. Mortalité maternelle en France, mieux comprendre pour mieux prévenir. Sages-Femmes. sept 2021;20(5):36-42
Deneux-Tharaux C, Bouvier-Colle MH. Severe acute maternal morbidity in France: the epimoms population-based study. Am J Obstet Gynecol. 1 janv 2017;216(1):S345-6
Godeberge C, Deneux-Tharaux C, Seco A, Rossignol M, Chantry AA, Bonnet MP; EPIMOMS Study Group. Maternal Intensive Care Unit Admission as an Indicator of Severe Acute Maternal Morbidity: A Population-Based Study. Anesth Analg. 2022 Mar 1;134(3):581-591. doi: 10.1213/ANE.0000000000005578.
PubMed 33989204Charbit B, Mandelbrot L, Samain E, Baron G, Haddaoui B, Keita H, Sibony O, Mahieu-Caputo D, Hurtaud-Roux MF, Huisse MG, Denninger MH, de Prost D; PPH Study Group. The decrease of fibrinogen is an early predictor of the severity of postpartum hemorrhage. J Thromb Haemost. 2007 Feb;5(2):266-73. doi: 10.1111/j.1538-7836.2007.02297.x. Epub 2006 Nov 6.
PubMed 17087729Deleu F, Deneux-Tharaux C, Chiesa-Dubruille C, Seco A, Bonnet MP; EPIMOMS study Group. Fibrinogen concentrate and maternal outcomes in severe postpartum hemorrhage: A population-based cohort study with a propensity score-matched analysis. J Clin Anesth. 2022 Oct;81:110874. doi: 10.1016/j.jclinane.2022.110874. Epub 2022 Jun 2.
PubMed 35662057Green L, Knight M, Seeney F, Hopkinson C, Collins PW, Collis RE, Simpson NA, Weeks A, Stanworth SJ. The haematological features and transfusion management of women who required massive transfusion for major obstetric haemorrhage in the UK: a population based study. Br J Haematol. 2016 Feb;172(4):616-24. doi: 10.1111/bjh.13864. Epub 2015 Dec 18.
PubMed 26683982Cortet M, Deneux-Tharaux C, Dupont C, Colin C, Rudigoz RC, Bouvier-Colle MH, Huissoud C. Association between fibrinogen level and severity of postpartum haemorrhage: secondary analysis of a prospective trial. Br J Anaesth. 2012 Jun;108(6):984-9. doi: 10.1093/bja/aes096. Epub 2012 Apr 6.
PubMed 22490316Ducloy-Bouthors AS, Mercier FJ, Grouin JM, Bayoumeu F, Corouge J, Le Gouez A, Rackelboom T, Broisin F, Vial F, Luzi A, Capronnier O, Huissoud C, Mignon A; FIDEL working group. Early and systematic administration of fibrinogen concentrate in postpartum haemorrhage following vaginal delivery: the FIDEL randomised controlled trial. BJOG. 2021 Oct;128(11):1814-1823. doi: 10.1111/1471-0528.16699. Epub 2021 Apr 7.
PubMed 33713384Liew-Spilger AE, Sorg NR, Brenner TJ, Langford JH, Berquist M, Mark NM, Moore SH, Mark J, Baumgartner S, Abernathy MP. Viscoelastic Hemostatic Assays for Postpartum Hemorrhage. J Clin Med. 2021 Aug 31;10(17):3946. doi: 10.3390/jcm10173946.
PubMed 34501395Huissoud C, Carrabin N, Audibert F, Levrat A, Massignon D, Berland M, Rudigoz RC. Bedside assessment of fibrinogen level in postpartum haemorrhage by thrombelastometry. BJOG. 2009 Jul;116(8):1097-102. doi: 10.1111/j.1471-0528.2009.02187.x. Epub 2009 May 12.
PubMed 19459866Collins PW, Cannings-John R, Bruynseels D, Mallaiah S, Dick J, Elton C, Weeks AD, Sanders J, Aawar N, Townson J, Hood K, Hall JE, Collis RE. Viscoelastometric-guided early fibrinogen concentrate replacement during postpartum haemorrhage: OBS2, a double-blind randomized controlled trial. Br J Anaesth. 2017 Sep 1;119(3):411-421. doi: 10.1093/bja/aex181.
PubMed 28969312Jokinen S, Kuitunen A, Uotila J, Yli-Hankala A. Thromboelastometry-guided treatment algorithm in postpartum haemorrhage: a randomised, controlled pilot trial. Br J Anaesth. 2023 Feb;130(2):165-174. doi: 10.1016/j.bja.2022.10.031. Epub 2022 Dec 7.
PubMed 36496259Sanfilippo S, Buisson L, Rouabehi H, Dujaric ME, Donnet T, de Raucourt E, Dumont B, Peynaud-Debayle E. The qLabs(R) FIB system, a novel point-of-care technology for a rapid and accurate quantification of functional fibrinogen concentration from a single drop of citrated whole blood. Thromb Res. 2023 Jun;226:159-164. doi: 10.1016/j.thromres.2023.03.018. Epub 2023 Apr 5.
PubMed 37178638
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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: a Prospective Multicenter Non-interventional Study
- ClinicalTrials.gov ID
- NCT06255002
- Acronym / sponsor ID
- FIB-HPPS / APHP231640
- Conditions
- Postpartum Hemorrhage
- Keywords
- Severe postpartum haemorrhage, Fibrinogen concentration, qLabs®FIB Monitoring system, Clauss fibrinogen assay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 2 Mar 2026 (actual)
- Study completion
- 2 Mar 2026 (actual)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Biological: Fibrinogen concentration by the qLabs®FIB Monitoring systemPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patients giving birth in the two type 3 maternity wards of the Paris Center University Hospital Group : Necker-Enfants Malades et Cochin Port Royal (APHP) and with severe postpartum hemorrhage.
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (3 listed)
- Opposition to participation in the study
- Presence of a constitutional fibrinogen deficiency
- Patients under guardianship or curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fibrinogen concentration by the qLabs®FIB Monitoring systemA 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. | Biological | Patients |
Primary outcome
Agreement between fibrinogen measurement by qLabs®FIB and by the Clauss method
Time frame: 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.
3 secondary outcomes
Evaluation of the ease of use of qLabs®FIB by the anesthesia team
Time frame: Through study completion, an average of 1 year
Evaluation of the time taken to obtain the fibrinogen concentration using the 2 methods
Time frame: Through study completion, an average of 1 year
Evaluation of measurement failure by qLabs®FIB
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Background: PubMed 26773243Sentilhes L, Vayssiere C, Deneux-Tharaux C, Aya AG, Bayoumeu F, Bonnet MP, Djoudi R, Dolley P, Dreyfus M, Ducroux-Schouwey C, Dupont C, Francois A, Gallot D, Haumonte JB, Huissoud C, Kayem G, Keita H, Langer B, Mignon A, Morel O, Parant O, Pelage JP, Phan E, Rossignol M, Tessier V, Mercier FJ, Goffinet F. Postpartum hemorrhage: guidelines for clinical practice from the French College of Gynaecologists and Obstetricians (CNGOF): in collaboration with the French Society of Anesthesiology and Intensive Care (SFAR). Eur J Obstet Gynecol Reprod Biol. 2016 Mar;198:12-21. doi: 10.1016/j.ejogrb.2015.12.012. Epub 2015 Dec 21.
- BackgroundBlondel B et al. Enquête nationale périnatale 2021
- BackgroundSaucedo M, Tessier V, Leroux S, Almeras A, Deneux-Tharaux C. Mortalité maternelle en France, mieux comprendre pour mieux prévenir. Sages-Femmes. sept 2021;20(5):36-42
- BackgroundDeneux-Tharaux C, Bouvier-Colle MH. Severe acute maternal morbidity in France: the epimoms population-based study. Am J Obstet Gynecol. 1 janv 2017;216(1):S345-6
- Background: PubMed 33989204Godeberge C, Deneux-Tharaux C, Seco A, Rossignol M, Chantry AA, Bonnet MP; EPIMOMS Study Group. Maternal Intensive Care Unit Admission as an Indicator of Severe Acute Maternal Morbidity: A Population-Based Study. Anesth Analg. 2022 Mar 1;134(3):581-591. doi: 10.1213/ANE.0000000000005578.
- Background: PubMed 17087729Charbit B, Mandelbrot L, Samain E, Baron G, Haddaoui B, Keita H, Sibony O, Mahieu-Caputo D, Hurtaud-Roux MF, Huisse MG, Denninger MH, de Prost D; PPH Study Group. The decrease of fibrinogen is an early predictor of the severity of postpartum hemorrhage. J Thromb Haemost. 2007 Feb;5(2):266-73. doi: 10.1111/j.1538-7836.2007.02297.x. Epub 2006 Nov 6.
- Background: PubMed 35662057Deleu F, Deneux-Tharaux C, Chiesa-Dubruille C, Seco A, Bonnet MP; EPIMOMS study Group. Fibrinogen concentrate and maternal outcomes in severe postpartum hemorrhage: A population-based cohort study with a propensity score-matched analysis. J Clin Anesth. 2022 Oct;81:110874. doi: 10.1016/j.jclinane.2022.110874. Epub 2022 Jun 2.
- Background: PubMed 26683982Green L, Knight M, Seeney F, Hopkinson C, Collins PW, Collis RE, Simpson NA, Weeks A, Stanworth SJ. The haematological features and transfusion management of women who required massive transfusion for major obstetric haemorrhage in the UK: a population based study. Br J Haematol. 2016 Feb;172(4):616-24. doi: 10.1111/bjh.13864. Epub 2015 Dec 18.
- Background: PubMed 22490316Cortet M, Deneux-Tharaux C, Dupont C, Colin C, Rudigoz RC, Bouvier-Colle MH, Huissoud C. Association between fibrinogen level and severity of postpartum haemorrhage: secondary analysis of a prospective trial. Br J Anaesth. 2012 Jun;108(6):984-9. doi: 10.1093/bja/aes096. Epub 2012 Apr 6.
- Background: PubMed 33713384Ducloy-Bouthors AS, Mercier FJ, Grouin JM, Bayoumeu F, Corouge J, Le Gouez A, Rackelboom T, Broisin F, Vial F, Luzi A, Capronnier O, Huissoud C, Mignon A; FIDEL working group. Early and systematic administration of fibrinogen concentrate in postpartum haemorrhage following vaginal delivery: the FIDEL randomised controlled trial. BJOG. 2021 Oct;128(11):1814-1823. doi: 10.1111/1471-0528.16699. Epub 2021 Apr 7.
- Background: PubMed 34501395Liew-Spilger AE, Sorg NR, Brenner TJ, Langford JH, Berquist M, Mark NM, Moore SH, Mark J, Baumgartner S, Abernathy MP. Viscoelastic Hemostatic Assays for Postpartum Hemorrhage. J Clin Med. 2021 Aug 31;10(17):3946. doi: 10.3390/jcm10173946.
- Background: PubMed 19459866Huissoud C, Carrabin N, Audibert F, Levrat A, Massignon D, Berland M, Rudigoz RC. Bedside assessment of fibrinogen level in postpartum haemorrhage by thrombelastometry. BJOG. 2009 Jul;116(8):1097-102. doi: 10.1111/j.1471-0528.2009.02187.x. Epub 2009 May 12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hawa KEITA-MEYER, MD-PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Marc SAMAMA, MD-PhD study director
Assistance Publique - Hôpitaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Hemorrhage, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between fibrinogen measurement by qLabs®FIB and by the Clauss method (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06255002, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.