Injecting a drug to stem severe post-childbirth bleeding is a safe, effective alternative to an IV drip, researchers have found – paving the way for the life-saving treatment to be used at home, in ambulances and at remote clinics across the globe.

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Edited by| Christian Megan

 

Healh   section -  CJ journalist

 

World – April,6,2023

 

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Each year, at least 70,000 women still die due to a postpartum haemorrhage – around a quarter of all maternal fatalities worldwide. But one of the most effective treatments, a clot stabiliser called tranexamic acid (TXA), is currently administered only via an IV drip, dramatically curtailing its use.

“The drug is only effective if it is given as early as possible after bleeding starts, and it’s no good after three hours,” said Professor Haleema Shakur-Still, a professor of global health clinical trials at the London School of Hygiene and Tropical Medicine.

Making sure this happens is not only difficult in remote, under-resourced health clinics, but also in ambulances or even at over-stretched hospitals, contributing to the “shocking” maternal death rate, she added.

“Most postpartum haemorrhages are diagnosed by midwives, but they are often not trained to deliver an IV… and we know that in most countries, there’s a shortage of doctors. That means there’s often a delay to administer TXA – the doctor is in an operating theatre or clinic, and getting to the women immediately is a problem.

TXA works as a clot stabiliser, which means it stops the body from breaking down clots when someone is bleeding severely

TXA works as a clot stabiliser, which means it stops the body from breaking down clots when someone is bleeding severely CREDIT: Saiyna Bashir / Wellcome Trust

“Having midwives who could deliver an injection will make a big difference,” Prof Shakur-Still said. “We also envisage a situation where you have a pre-filled syringe with the drug that the police or ambulance can administer in an emergency.”

According to the results of a phase two trial, co-led by Prof Shakur-Still and published in the British Journal of Obstetrics and Gynaecology on Thursday, this is feasible.

In the study, which included 120 women at risk of a postpartum haemorrhage in Pakistan and Zambia, participants received a TXA injection, tablet or placebo before any bleeding began.

While both alternatives to an IV drip were deemed safe for mothers and newborns, a tablet took an hour to reach a high enough concentration to have any impact. But it took just 10 minutes via an injection, which is the same rate as an IV drip.

Researchers are launching a broader phase three trial with 30,000 women in August to further test efficacy, which would pave the way for updated World Health Organization guidance on use within the next three years – an outcome that, given previous studies, they’re optimistic about.

TXA works as a clot stabiliser, which means it stops the body from breaking down clots when someone is bleeding severely. It was developed to treat trauma patients, and an injectable version has been used by paramedics in the UK since 2020 after a trial found it was effective.

“The military were the first to express an interest in an injectable form of TXA, which soldiers could carry in the field to use if they’re injured,” said Prof Shakur-Still. “We did a study that shows the absorption in trauma victims was very good if you deliver it [as an injection], and in the UK that is now accepted as standard treatment.”

If the same were to be the case for postpartum pregnancy, she added, it would save “tens of thousands” of lives.

“The [injection] route will be very helpful in Pakistan,” said Prof Rizwana Chaudhri, co-author of the study from Shifa Tameer-e-Millat University in Pakistan.

“With some patients who are experiencing a postpartum haemorrhage, it is difficult to get an intravenous line established, so anything that can reduce [severe bleeding] will be useful. In some cases, it will be the first and last choice.”

While there have been huge strides in reducing maternal mortality in recent decades – estimated fatalities have dropped from 446,000 in 2020 to around 290,000 in 2020 – recent progress has stalled or even reversed, the UN warned in February.

The vast majority take place in sub-Saharan Africa and south Asia, and huge numbers are preventable. As well as severe bleeding, infections, complications from delivery, high blood pressure and unsafe abortions are major killers.

“For millions of families, the miracle of childbirth is marred by the tragedy of maternal deaths,” Catherine Russell, executive director of Unicef, said when the latest report came out. “No mother should have to fear for her life while bringing a baby into the world, especially when the knowledge and tools to treat common complications exist.”

As well as making drugs such as TXA – which reduces the risk of a woman bleeding to death by 30 per cent if delivered within three hours – Prof Shakur-Still said more work is needed to make it available everywhere.

“We really have to work at that, because not only is it going to save young men from road traffic crashes and deaths, from all kinds of trauma, but it will save the lives of young mothers,” she said.

“In the UK, the treatment is about £1, but in countries including Nigeria it’s more expensive because of the middle men and distributors. It’s a generic drug and cheap to administer, there is no reason that this should be happening.”

But Prof Shakur-Still added that the “single biggest” intervention to reduce the number of women dying in childbirth is to diagnose and treat anaemia.

“Anaemia is very prevalent right across sub-Saharan Africa and southeast Asia, and a lot of the time when a woman comes to give birth she’s so weakened by anaemia that an infection or bleeding … can have a really detrimental impact,” she said. “So ensuring TXA is easily and widely available is critical, but it’s not the only intervention needed to save lives.”

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