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.