Prompt tranexamic acid administration reduces death due to postpartum haemorrhage
Women given tranexamic acid within three hours of giving birth appear to have a reduced risk of death due to postpartum haemorrhage (PPH), according to findings of the large, multinational WOMAN* trial.
Women given a 1 g dose of tranexamic acid had a significantly reduced risk of death due to bleeding compared with those given placebo (1.5 percent [n=155] vs 1.9 percent [n=191], risk ratio [RR], 0.81, 95 percent confidence interval [CI], 0.65–1.00; p=0.045). The risk of death due to bleeding was especially reduced in women given tranexamic acid within three hours of giving birth (1.2 percent [n=89]) compared with placebo (1.7 percent [n=127], RR, 0.69, 95 percent CI, 0.52–0.91; p=0.008), while there appeared to be no reduction in risk if tranexamic acid was administered after three hours (2.6 percent [n=66] vs 2.5 percent [n=63] in the tranexamic acid and placebo groups, respectively, RR, 1.07, 95 percent CI, 0.76–1.51; p=0.70). [Lancet 2017;doi:10.1016/S0140-6736(17)30638-4]
The risk of hysterectomy to control bleeding did not significantly differ between women given tranexamic acid or placebo (2.8 percent vs 3.0 percent, RR, 0.95; p=0.57), nor did the primary endpoint of death from all causes or hysterectomy within 42 days of giving birth (5.3 percent vs 5.6 percent, RR, 0.97; p=0.65). Laparotomy to control bleeding was more frequent in the placebo group compared with the tranexamic acid group (1.3 percent vs 0.8 percent, RR, 0.64; p=0.002).
Incidence of thromboembolic events and deaths due to pulmonary embolism, organ failure, sepsis, eclampsia, and other causes were comparable between the two groups.
In this multicentre (193 hospitals in 21 countries), double-blind trial, women aged ≥16 years (n=20,060) diagnosed with PPH after a vaginal birth or Caesarean section were randomized to receive tranexamic acid (1 g administered intravenously at 1mL/min; n=10,051) or placebo (n=10,009) plus usual care. In the incidence of persistent bleeding (after 30 minutes) or cessation and resumption of bleeding (within 24 hours of the first dose), a second dose of tranexamic acid (1 g) or placebo was allowed. After accounting for withdrawals and exclusions, 10,037 and 9,975 women were administered the first dose of tranexamic acid and placebo, respectively.
A total of 483 maternal deaths occurred, 374 (77 percent) and 43 (9 percent) within 24 and 1 hour of randomization, respectively. Of these, 346 (72 percent) occurred as a result of bleeding. Of the 709 hysterectomies done, 81 percent (n=578) were to control bleeding.
Based on trials that demonstrated the efficacy of tranexamic acid in treating trauma-related bleeding, the World Health Organization, in 2012, recommended the use of tranexamic acid in treating PPH in the incidence of bleeding due to trauma or if uterotonics were insufficient to control bleeding, said the researchers.
“The WOMAN trial results show that the effect of tranexamic acid in [PPH] is consistent with the effects recorded in surgery and trauma,” said the researchers. “Our results support the inclusion of tranexamic acid ... for [PPH] but suggest that treatment should be given as soon as possible after onset,” they said, and called for studies into determining the efficacy of tranexamic acid following alternative administration routes to assess its feasibility of use in situations where intravenous administration may not be possible.