A study to measure the efficacy of tranexamic acid to reduce post partum haemorrhage volume

The volume of blood loss between enrollment and 6 hours later

1. Duration of bleeding and the impact of TA on PPH-related outcome [decrease in haemoglobin concentration, transfusion of packed red blood cells (PRBC) at T4 and at day 42, and the need for invasive procedures (uterine artery embolisation or ligature, hysterectomy), late post-partum curettage or general outcome (intensive care unit stay, use of any vasopressors, dyspnoea, renal and multiple organ failure)].
2. Severe PPH was defined according to Charbit et al. as exhibiting one of the following criteria:
2.1. Peri-partum decrease of haemoglobin > 4g/dL, with the last haemoglobin value before delivery considered as the reference
2.2. Transfusion of at least four packed red blood cells (PRBC)
2.3. Invasive haemostatic intervention
2.4. Death
Evaluation of each endpoint was performed by investigators blinded to treatment allocation.
3. Side effects: Although the study was not powered to address safety issues, side effects that could be related to TA were analysed. Major (thrombotic events, renal failure, seizures) and minor side effects were reported at each time point 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.