Blood haemoglobin level was also measured (HemoCue; HemoCue Meaux France). Blood samples were collected and tested for haemoglobin www.selleckchem.com/products/Temsirolimus.html concentration and hematocrit. Bleeding was considered to have stopped when the flow was <50 mL/10 minutes.In both study groups, packed red blood cells (PRBCs) and colloids could be used according to French guidelines. Vascular loading was as follows: crystalloid Ringer's lactate solution (Macoflex; Boulogne Billancourt, France) (500 mL) and the gelatin plasma expander Gelofusine 4% (B-Braun Medical, Boulogne Billancourt, France) (500 mL) for the first bleeding litre, then an infusion of gelatin was administered to compensate for blood loss (vol/vol). When blood loss exceeded 2,500 mL, loading was partially supported by an infusion of fresh frozen plasma (FFP).

According to French guidelines, infusion of PRBCs was indicated when the patient’s haemoglobin level was <8 g/dL.In both study groups, the use of additional procoagulant treatment (FFP, platelets and fibrinogen concentrate) was not permitted before T3. However, at any time in both groups, additional procoagulant treatments or invasive procedures could be used in cases of intractable bleeding (PPH >2,500 mL or blood flow >500 mL/30 minutes).According to national guidelines, postpartum thromboprophylaxis was carried out with low-molecular-weight heparin 50 IU/kg/day in the patients in severe condition in both groups from day 1 until the inflammatory syndrome disappeared.Criteria for evaluationThe primary end point was the volume of blood loss between T1 and T4.

Secondary end points were duration of bleeding and the impact of TA on PPH-related outcome (decrease in haemoglobin concentration; transfusion of PRBCs at T4 and at day 42; and the need for invasive procedures (uterine artery embolisation or ligature, hysterectomy), late postpartum curettage or general outcome (intensive care unit stay, use of any vasopressors, dyspnoea, renal and multiple organ failure)). Severe PPH was defined by Charbit et al. [8] as exhibiting one of the following criteria: peripartum decrease of haemoglobin >4 g/dL, with the last haemoglobin value before delivery considered as the reference; transfusion of at least 4 U of PRBCs; invasive haemostatic intervention; or death. Evaluation of each end point was performed by investigators blinded to treatment allocation.

Side effectsAlthough this study was not powered to address safety issues, side effects that could be related to TA were analyzed. Major side effects (thrombotic events, renal failure or seizures) and minor side effects were reported at each time point GSK-3 and at day 42. With respect to venous thrombosis, clinical signs of superficial or deep thrombosis were collected, and ultrasonography was performed as soon as the signs were detected.