Objectives and Endpoints
The primary objective was to assess the benefits of early administration
of fibrinogen for PPH management and reduction of bleeding after
initiation of a sulprostone intravenous infusion. The primary efficacy
criterion was a composite failure endpoint defined as loss of at least 4
g/dL of Hb and/or need for transfusion of at least 2 units of packed red
blood cells (RBCs) within the 48 hours following the IMP infusion. The
Hb reference level was the most recent Hb value recorded in the third
trimester of pregnancy (to get rid of the influence of initial
haemorrhage).
The secondary objectives were to assess the evolution of haemorrhage and
its management by further haemostatic interventions, as well as the
safety of fibrinogen administration via adverse events collection19.
Study data were collected prospectively, from the day of delivery until
the end of follow-up at 6 ± 2 weeks 19.