Results From the Landmark Trial on Tranexamic Acid for Postpartum Hemorrhage
Tranexamic acid, an anti-fibrinolytic medication, has been shown in the trauma literature to be highly effective in reducing deaths due to bleeding. The aim of this study by the WOMAN Trial Collaborators (Lancet, 2017) was to determine if early administration of tranexamic acid could likewise be beneficial in the setting of postpartum hemorrhage (PPH).
Randomized, double-blind, placebo-controlled trial – multicentered (193 hospitals/21 countries), conducted between March 2010 and April 2016.
20,060 women were enrolled and randomized to receive either 1 g (100 mg/mL) of tranexamic acid intravenously at a rate of 1 mL per min or placebo. If bleeding continued after 30 min or stopped and restarted within 24 h of the first dose, a second dose of 1 g of tranexamic acid or placebo could be given. Key findings include:
Death due to bleeding was reduced by approximately 30% in the treatment group (risk ratio 0.69, 95% CI 0.52-0.91; p=0.008) if drug given within 3 hours of birth
There did not appear to be reduction if medication given after 3 hours
Laparotomy to control bleeding was similarly significantly reduced in the treatment group (risk ratio 0.64, 95% CI 0.49 – 0.85; p=0.002)
There was not difference in hysterectomy rates
There was no difference in overall death rates or deaths due to hysterectomies
There was no difference in adverse events, including those related to thromboembolism
Reduction in death rates by approximately a third mirrored findings in trauma patients
Strengths of study:
Well designed to answer question
Tranexamic acid is low cost and could potentially save tens of thousands of women’s lives worldwide annually
Authors recommend tranexamic acid be given early in PPH and not after uterotonics have failed
Limitations of study:
Primary issue is generalizability to higher resource regions
Tranexamic acid may have more impact on hysterectomy prevention where hysterectomy is a last resort vs. an early lifesaving intervention
Tranexamic acid may have more impact on overall death rates in countries where other causes of maternal death are lower (e.g., sepsis)
Tranexamic acid in this study was administered by IV which may be limiting in regions with limited maternal health resources
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