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Protecting Mothers and Babies: A Delicate Balancing Act

balancing fibrin clot formation and fibrinolysis. TXA inhibits fibrinolysis, therefore preventing clot breakdown, and was demonstrated to reduce mortality in bleeding trauma patients in the CRASH 2 trial if given within 3 hours.1 A Cochrane review in 20072 of 211 RCTs included 20,781 randomized patients undergoing elective surgery and demonstrated a reduced risk of blood transfusion and mean transfused volume when TXA was used. This paper is a systematic review of 12 RCTs evaluating the use of TXA in the prevention and treatment of PPH and all predate the large WOMAN trial published in 2017 (a double blind placebo controlled RCT evaluating the use of TXA in over 20,000 woman with a diagnosis of PPH).3 All studies were performed in low-middle income countries, and 10 of the 12 included only elective ceserean deliveries. Overall, the authors of the systematic review felt the quality of the RCTs were poor. This affirmed the need for a large RCT like the WOMAN trial. The authors looked at the prevention of PPH, a question not addressed in the WOMAN trial. Ten of the RCTs reported the role of TXA in the prevention of PPH after elective cesarean delivery. While they all showed a reduction in blood loss and no increase in adverse events, the authors highlighted several flaws, including randomization methods and variable blood loss assessment methods in the papers. It is worth noting all 10 were underpowered to assess for adverse events. Taking the limitations into account, the applicability of these results are debatable. Two trials assessed the prevention of PPH postvaginal delivery and both showed a reduction in blood loss with TXA. Again, both studies had limitations; one study had no placebo and was not blinded and the other was underpowered to assess adverse events. The authors found a single paper addressing TXA for the treatment of PPH (EXADELI trial). Patients with a PPH > 800mL after vaginal delivery were randomized to receive a large dose (4 g in 1 h IV then 1 g/h over 6 h) of TXA or nothing. Measured blood loss was lower in the TXA group (mean 173 vs. 221 mL), with a shorter duration of bleeding and less progression to further PPH, with a reduced requirement for packed red blood cells. There were more mild adverse events in the TXA group, such as nausea/ vomiting, but no increase in thrombosis. The role of TXA in the treatment of PPH has subsequently been addressed by the WOMAN trial. TXA reduced the risk of death due to bleeding (1.5% vs. 1.9%) with no increase in adverse events including thrombosis. While the magnitude of the benefit in the WOMAN trial is modest, adverse effects that previously limited its use, typically thrombosis, were shown not to be an issue. The evidence from these earlier studies in this systematic review adds to the growing evidence of the effectiveness of TXA in prevention and treatment of PPH without significant adverse effects.