Introduction
Postpartum haemorrhage (PPH) affects up to 10% of all deliveries, with a trend towards the incidence increasing over time in developed countries 1,2. It is the leading cause of maternal mortality worldwide and accounts for up to 75% of severe maternal morbidity 3. Multidisciplinary PPH management requires early diagnosis, identification of the underlying aetiology, rapid resuscitation, and medical and surgical treatment 4,5.
Acquired coagulopathy is a major aggravating factor of blood loss6,7. During PPH, plasma fibrinogen is the first coagulation factor to drop precipitously due to bleeding, hyperfibrinolysis (consumption), and haemodilution 8. Additionally, fibrinogen is an early biomarker for worsening of PPH. The risk of progression to severe PPH increases almost 3 fold for each 1 g/L decrease in fibrinogen concentration, and a positive predictive value of 100% for progression to severe PPH is observed with fibrinogen concentrations under 2 g/L 9-12.
Fibrinogen replacement therapy for severe bleeding has therefore gained popularity 13-15. A multidisciplinary task force for advanced bleeding care in PPH patients recommends fibrinogen replacement if plasma level drops below 2 g/L 16. However, it remains debated whether systematic fibrinogen administration at an earlier stage may be helpful 17,18, namely before plasma level determination. We therefore designed the FIDEL study based on the hypothesis that early and systematic treatment with a significant amount of fibrinogen concentrate (3 g) could reduce the need for red blood cell transfusion (to less than 2 RBC units) in PPH patients requiring a switch from oxytocin to prostaglandins and/or would limit postpartum haemoglobin decreases 48 hours after delivery to less than 4 g/dL.