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.