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Postpartum haemorrhage (PPH) is a leading cause of maternal death. Present guidelines for PPH management focus on uterotonic treatments, while the potential efficacy of antifibrinolytic drugs has been poorly explored in this indication.
After approval by the ethics committee, we randomly assigned women with PPH >800 ml after vaginal delivery to receive intravenous tranexamic acid (TXA) (4 g within 1 hour, followed by 1 g/hour during 6 hours) (TXA group) or no antifibrinolytic treatment (Control group). Monitoring and management were performed according to the guidelines. Additional procoagulant treatments (coagulant concentrates, fresh frozen plasma, platelets) were used only when PPH became intractable (>2,500 ml or >500 ml/30 minutes). Embolization or surgery was performed when considered clinically necessary. Blood loss, maternal morbidity and safety were collected at four time points: inclusion (T1), T1 + 30 minutes (T2), T1 + 2 hours (T3), and T1 + 6 hours (T4). The study plan, based on the hypothesis that TXA would induce a 20% blood loss reduction with an α risk of 5% and a β risk of 10%, required the inclusion of 72 patients in each group. Statistical analysis used the SAS system.
One hundred and forty-four patients were included, 72 in the TXA group and 72 in the control group. Management data were similar between the two groups. In the TXA group, as compared with the control group: blood loss was 46% lower between T2 and T3 (P = 0.026), and 49% lower between T2 and T4 (P = 0.0012); bleeding duration was shorter (31 ± 28 vs 65 ± 95 minutes, P = 0.004); and maternal morbidity was reduced (hemoglobin drop >4 g/dl: n = 15 vs 34, P < 0.001; blood transfusion requirement: n = 14 vs 20, P = NS; overall number of transfused packed red blood cells: n = 42 vs 62, P < 0.001; number of severe PPH (Charbit criteria 1): n = 23 vs 36, P = 0.028). Invasive procedures were needed in four women in the TXA group and in seven women in the control group (P = NS). Transient visual and digestive side effects were observed more frequently in the TXA group than in the control group (17 vs 4 P = 0.028).
These results show, for the first time, that TXA, when administered early in the management of PPH, reduces blood loss and maternal morbidity, with only minor and transient side effects. As TXA is a readily available and cheap hemostatic agent, we strongly suggest that it should be further investigated as an adjuvant treatment in PPH.