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Low-cost drug reduces maternal mortality from post-partum haemorrhage

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A cheap and widely available medication can reduce deaths from severe bleeding after childbirth, the leading cause of maternal mortality worldwide, according to a major trial led by UK researchers.

Tranexamic acid could reduce maternal deaths among women with severe bleeding after child birth, according to a global trial of 20,000 women in 21 countries.

“It’s safe, affordable and easy to administer”

Haleema Shakur

The study found maternal deaths were reduced by 31%, and urgent surgery to stop life-threatening bleeding was decreased by 36%, if the treatment was given within three hours of delivery.

The researchers noted that post-partum haemorrhage is the leading cause of maternal death worldwide, responsible for 100,000 deaths per year.

Tranexamic acid works by stopping fibrinolysis, a process that can occur in trauma or soon after birth. Previous research has shown that it reduces death due to bleeding in trauma patients.

Current World Health Organization guidance recommends using tranexamic acid for post-partum haemorrhage if uterotonics fail to control the bleeding, or if the bleeding is thought to be due to trauma.

“We hope can help save women’s lives around the world”

Ian Roberts

But the findings from the trial, published today in The Lancet, suggest that the drug should be given as soon as possible after the onset of post-partum haemorrhage, at the same time as uterotonics.

The WOMAN (World Maternal Antifibrinolytic) trial included over 20,000 women aged 16 or over in 193 hospitals in 21 countries, mostly in Africa and Asia.

Women diagnosed with post-partum haemorrhage after a vaginal birth or caesarean section were randomised to receive either 1g of intravenous tranexamic acid or placebo, in addition to usual care.

If bleeding continued after 30 minutes, or stopped and restarted within 24 hours of the first dose, a second dose was given.

Death due to bleeding was reduced in women given tranexamic acid compared to placebo, with 1.5% of women given tranexamic acid dying of bleeding compared to 1.9% of those given placebo.

Tranexamic acid was particularly effective when given within three hours of bleeding, reducing deaths by a third – 1.2% of women given it within this timeframe died versus 1.7% for placebo.

“The results of this important trial are very welcome”

Lesley Regan

There was also a reduction in laparotomy in the tranexamic acid group, compared to the placebo group – 0.8% versus 1.3%.

In addition, there was no difference in the rates of adverse effects in the tranexamic acid group compared to placebo.

However, the study authors noted that deaths from other causes – such as pulmonary embolism, organ failure, sepsis and eclampsia – did not differ between groups and nor did hysterectomy rates.

Associate Professor Haleema Shakur, from the London School of Hygiene and Tropical Medicine, who led the trial, said: “We now have important evidence that the early use of tranexamic acid can save women’s lives and ensure more children grow up with a mother.

London School of Hygiene and Tropical Medicine

Cheap drug cuts death from bleeding after childbirth

Haleema Shakur

“It’s safe, affordable and easy to administer, and we hope that doctors will use it as early as possible following the onset of severe bleeding after childbirth,” she said.

Co-author Professor Ian Roberts, also from LSHTM, added: “The researchers who invented tranexamic acid more than 50 years ago hoped it would reduce deaths from postpartum haemorrhage, but they couldn’t persuade obstetricians at the time to conduct a trial.

“Now we finally have these results that we hope can help save women’s lives around the world,” he noted.

In a linked editorial on the trial, The Lancet itself described the findings as an “important milestone” in the “high priority” search for new ways to prevent maternal death, especially from bleeding.

Professor Lesley Regan, president of the Royal College of Obstetricians and Gynaecologists, said: “The results of this important trial are very welcome.”

Royal College of Obstetricians and Gynaecologists

Cheap drug cuts death from bleeding after childbirth

Lesley Regan

“Although post-partum haemorrhage is rare in the UK, there hasn’t been a significant reduction in the number of deaths from the condition since 2009,” he said.

“Previous research has shown the benefits of the medication, but this latest study provides reassurance that there are no side effects from the drug for mothers or babies,” he added.

Professor Regan also highlighted that post-partum haemorrhage was an “obstetric emergency” and that all staff involved in maternity care should have appropriate training to treat women with it.

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