“If you want to know how strong a country’s health system is, look at the well-being of its mothers.” – Hillary Clinton

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

Background

• Post partum haemorrhage (PPH) – leading cause of maternal death worldwide
• Aim: to study to role of early administration of tranexamic acid on death, hysterectomy and other outcomes in woman with PPH

Methods

• Randomised double-blind placebo controlled trial
• Inclusion criteria: women aged > 16 years with PPH post vaginal birth or C-section
• Randomisation: selection of a numbered treatment pack from a box containing 8 packs which were identical apart from their numbers
• Enrollment: Originally 15,000 woman but this was increased to 20,000 part way through because it came to light that in many cases, the decision to given tranexamic acid and the decision to perform a hysterectomy were made at the same time
• Intention to treat analysis

Intervention

• 1g tranexamic acid or placebo in addition to usual care
• Second dose of 1g of tranexamic acid or placebo given if bleeding continued after 30 mins, or it stopped but restarted within 24 hours of the first dose

Primary End points

• Death from all causes
• Hysterectomy within 42 days of randomisation

Secondary End points

• Cause-specific death with analysis of death due to bleeding
• Thromboembolic events
• Surgical interventions
• Untoward medical events
• Complications
• Quality of life measured with EQ5D
• Status of thromboembolic events in breastfed babies

Results

• Death due to bleeding was reduced in women given tranexamic acid (155/10036) vs those given the placebo (191/9985) — risk ratio: 0.81 95% CI 0.65-1.00, p = 0.045. Greatest effect was seen in women given tranexamic acid within 3 hours of PPH (RR 0.69, 95% CI 0,52 – 0.91, p =0.008)
• No reduction in death from all causes or hysterectomy
• No increase in adverse thromboembolic events

Discussion

• Tranexamic acid reduces risk of death due to bleeding with minimal adverse events
• It should be given as soon as possible when bleeding begins

Summary by Dr Nisha Sriram

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Second Opinion

Summary over at The Bottom Line