PPH evolution, anaemia, need for transfusion
and invasive procedures, and maternal morbi-
mortality: Hb drop compared with the reference
level, percentage of patients developing anaemia
(Hb < 8g/dl), requirement for PRBC transfusion or
any other blood products, requirement of
intrauterine balloon tamponade and/or invasive
procedure (arterial ligature, or embolisation, or
hysterectomy), and calculated blood loss.
Regarding the population selection, evidence
has shown that fibrinogen supplementation
may be more efficient in patients with
hypofibrinogenemia. The study population
may therefore be better selected among patients
with quite severe PPH at risk of developing
coagulopathy. The criteria of selection was to
enrol patients at the beginning of prostaglandin
(sulprostone; Nalador ® ) administration, which is
a time-validated second step of uterotonic
treatment in the algorithm of the French PPH
management guidelines (30 French guidelines).
Prostaglandins are advocated after no more than
30 minutes of ongoing PPH and oxytocin failure.
This inclusion criterion has been used previously. 4
Randomisation stratification by centres should
protect against the bias of variable team reactivity
times in taking the decision for oxytocin–
prostaglandin switch. Thromboelastometric
identification of coagulopathic patients was not
chosen in the FIDEL protocol because most of the
centres are not equipped to perform this.
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