New Delhi, April 26: A global clinical trial has shown that an inexpensive drug called tranexamic acid can reduce maternal deaths among women with severe bleeding after childbirth, researchers said today, recommending a revision in labour room practices to combat bleeding.

The trial involving over 20,000 women scattered across 21 countries has found that tranexamic acid - which costs only about Rs 180 per vial in India - when given within three hours of the onset of post-partum bleeding reduced the maternal deaths by one-third.

The findings also complete the dream of a Japanese medical scientist, Otako Okamoto, who had in 1962 discovered tranexamic acid but failed to convince her colleagues to use it to treat post-partum bleeding. Okamoto died last year, aged 98, aware of the trial and confident it would succeed.

"We have to make sure that every single doctor who looks after women with post-partum bleeding knows these results," Haleema Shakur-Still, associate professor of clinical trials at the London School of Hygiene and Tropical Medicine, who led the trial told The Telegraph.

Indian institutions had initially intended to participate in the trial but pulled out because of regulatory hurdles, she said. But the findings are relevant to India, which has a high burden of maternal mortality and where tranexamic acid is not routinely used to treat post-partum bleeding.

Tranexamic acid is already used to control excessive bleeding in victims of trauma and in patients who have had dental procedures. Gynaecologists also use it to treat excessive menstrual bleeding.

But existing World Health Organisation guidelines recommend tranexamic acid in post-partum bleeding only after other drugs used to reduce uterine contractions have failed to stop bleeding.

"It is time now to use tranexamic acid as a first-line therapy, our evidence supports such a revision," Shakur-Still said.

In the trial, 1.5 per cent (155 of 10,036) women given tranexamic acid died from bleeding compared to 1.9 per cent (191 of 9,985) women who received a placebo injection and other standard treatment. Tranexamic acid also reduced the need for laparotomy, or surgery to control the bleeding.

The study's findings were published today in The Lancet, a research journal.

"These are very significant results for India - post-partum bleeding is among the most common causes of maternal mortality," said Rishma Dhillon-Pai, a Mumbai gynaecologist and president of the Federation of Obstetrics and Gynaecological Societies of India (FOGSI), an apex body with a membership of about 34,000 gynaecologists.

Gynaecologists say post-partum bleeding is an acute event that cannot be predicted. While some women at high risk of this childbirth complication, doctors say it can occur in any woman, even after a perfectly normal delivery. Pai said FOGSI is likely to use workshops to promote the use of tranexamic acid. "The drug is inexpensive and widely available," she said.

Okamoto had discovered tranexamic acid's capacity to control bleeding through experiments while at Keio University in Tokyo in 1962 and wanted to use it to control post-partum bleeding. "But she could not convince doctors to do the necessary trials - our trial fulfills her dream," Shakur-Still said.

A colleague of Shakur-Still had met Okamoto who was aware of the global clinical trial. "She told my colleague: I already know the result."

The UK-based researcher and her colleagues had initially planned to include India in the trial, collaborating with the Indian Council of Medical Research.

The study protocol had received approvals from various layers of India's regulatory system, but new rules from 2013 requiring mandatory audio-visual recording of the consent form from trial volunteers stalled the process.

"Post-partum bleeding is an emergency - it's not possible to always get genuine informed consent in such situations," said Shakur-Still, who had four years ago co-authored a paper with neurologists in India cautioning that such rules would preclude India from participating in trials involving emergency situations, including head injury.