Early and Systematic Administration of Fibrinogen Concentrate in
Postpartum Haemorrhage Following Vaginal Delivery: The FIDEL Randomized
Controlled Trial.
Abstract
Objective: To assess the benefits and safety of early human fibrinogen
concentrate (FC) in postpartum haemorrhage (PPH) management. Design:
Multicentre, double-blind, randomized placebo-controlled trial.
Setting:30 French hospitals. Population: patients with persistent PPH
after vaginal delivery requiring a switch from oxytocin to
prostaglandins. Methods: Within 30 min after introduction of
prostaglandins, patients received either 3 g FC or placebo. Main outcome
measures: Failure as composite primary efficacy endpoint: at least 4
g/dL of haemoglobin decrease and/or transfusion of at least 2 units of
packed red blood cells within 48h following investigational medicinal
product administration. Secondary endpoints: PPH evolution, need for
haemostatic procedures, and maternal morbidity-mortality within 6±2
weeks after delivery. Results: the intention-to-treat analysis included
437 patients of which 224 received FC and 213 placebo. At inclusion,
blood loss (877 ± 346mL) and plasma fibrinogen (FG) (4.1 ± 0.9g/L) were
similar in both groups (mean ± SD). Failure rates were 40.0% and 42.4%
in the FC and placebo groups, respectively (OR=0.99) after adjustment on
centre and baseline FG; (95%CI: [0.66;1.47]; p=0.96). No
significant differences in secondary efficacy outcomes were observed.
The mean plasma FG was unchanged after 2 hours in the FC group and
decreased by 0.56 g/L in the placebo group. No thromboembolic or other
relevant adverse effects were reported in the FC group, versus two in
the placebo group. Conclusions: Early and systematic administration of 3
g fibrinogen concentrate did not reduce blood loss, transfusion needs,
and postpartum anaemia, but prevented plasma fibrinogen decrease without
any subsequent thromboembolic events.