Phase 4
Completed N=437
Fibrinogen in Haemorrhage of Delivery
Post-Partum Hemorrhage
Source: ClinicalTrials.gov NCT02155725 ↗
Enrolled (actual)
437
Serious AEs
4.6%
Results posted
Sep 2020
Primary outcomePrimary: Failure Rate of PPH Management — 75; 80; 92; 92 Participants — p=0.9563
◆ Published Evidence
Established
80citations · ~16 / year
Early and systematic administration of fibrinogen concentrate in postpartum haemorrhage following vaginal delivery: the FIDEL randomised controlled trial.
Summary
The purpose of the study is to assess the benefits of a therapeutic strategy that associates an early administration of human fibrinogen concentrate in the management of PPH on the reduction of bleeding after the initiation of prostaglandins intravenous infusion, following vaginal delivery.
Linked Publications
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Early and systematic administration of fibrinogen concentrate in postpartum haemorrhage following vaginal delivery: the FIDEL randomised controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Failure Rate of PPH Management |
75; 80; 92; 92; 88; 89 | 0.9563 |
| SECONDARY Patients With at Least Administration of 2 Units of RBCs |
51; 52 | 0.9786 |
| SECONDARY Patients With Loss of at Least 4 g/dL of Hb |
42; 41 | 0.9474 |
Eligibility Criteria
Inclusion Criteria
- Signed and dated informed consent form
- Vaginal delivery
- PPH requiring IV administration of prostaglandins
- At least one available result of Hb level during the third trimester of pregnancy
- 18-year-old female patients and older
- Covered by healthcare insurance in accordance with local requirements
Exclusion Criteria
- Caesarean section
- Haemostatic intervention (as ligation, embolization or hysterectomy) already decided at the time of inclusion
- Known placenta praevia or accreta
- Hb level < 10g/dl during the third trimester of pregnancy
- History of venous or arterial thromboembolic event
- Known inherited bleeding or thrombotic disorders
- Treatment with low-molecular-weight heparin (LMWH) within 24 hours prior to the inclusion
- Treatment with acetylsalicylic acid within 5 days prior to the inclusion
- Treatment with vitamin K antagonists within 7 days prior to the inclusion
- Administration of fibrinogen concentrate within 48 hours prior to the inclusion
- Administration of FFP, platelets units or prohaemostatic drugs, tranexamic acid and rFVIIa or prothrombin complex concentrates (PCC) within 48 hours prior to the inclusion
- Administration of RBCs within 3 months prior to the inclusion
- Participation in another interventional clinical study within 30 days prior to the inclusion
- Previous inclusion/enrolment in the present clinical study
- Known history of hypersensitivity or other severe reaction to any component of Clottafact® or placebo
- Minors, majors under guardianship, persons staying in health or social institutes and people deprived of their freedom
- Known drug or alcohol abuse
- Patients whose use of concomitant medication may interfere with the interpretation of data
- Any other current significant medical condition that might interfere with treatment evaluation according to the investigator's judgement
- Patients who are unlikely to survive through the treatment period and evaluation
- Patients transferred from another service
Data sourced from ClinicalTrials.gov (NCT02155725) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.