PURPOSE:

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).

METHODS:

Randomized, double-blind, placebo-controlled trial – multicentered (193 hospitals/21 countries), conducted between March 2010 and April 2016.

RESULTS:

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

SUMMARY:

• 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

Learn More – Primary Sources:

Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial

Editorial: WOMAN: reducing maternal deaths with tranexamic acid

Related ObG Topics:

Postpartum Hemorrhage – Medications to Treat Uterine Atony 

Does ART Increase Risk of Postpartum Hemorrhage?

Placenta Accreta Spectrum Disorder: Definitions and Management