Life-changing clinical trials take honours at national awards

Finalist was the PRECISE trial led by the Musculoskeletal Health Sydney Research Group, which revealed that pregabalin, a common medication for sciatica has no benefit and is linked to a higher risk of adverse health events.

Winner of Trial of the Year was the Australian Placental Transfusion Study that discovered that delayed clamping of the umbilical cord in preterm infants cuts the relative risk of death by a third.

Importantly, both trials have led to changes in clinical practice leading to life-changing, life-saving benefits in tens of thousands of people globally.

The PRECISE trial

The PRECISE trial, published last year in The New England Journal of Medicine, investigated the benefits and harms of pregabalin in patients with sciatica. Pregabalin is widely used globally and has been increasingly prescribed in Australia for back pain and sciatica.

“The trial found that taking pregabalin did not reduce the severity of leg pain, or improve other health outcomes, compared to placebo in the treatment of sciatica,” said the study’s senior author, Associate Professor Christine Lin of the University of Sydney.

“However, trial participants who took pregabalin had a higher risk of unwanted effects such as dizziness. These findings are significant for patient care and clinical practice because they provide strong evidence that this common medicine should be avoided in people with sciatica.”

The PRECISE trial was the first to rigorously examine the efficacy of pregabalin in sciatica and the findings do not support its continued use for this condition. 

Practice changing

“Despite pregabalin’s widespread use, until the PRECISE trial there was limited evidence informing its use for sciatica,” says Dr Jane Latimer, a professor in the School of Public Health and Co-Deputy Director of the Musculoskeletal Health Sydney Research Group.

“Support for using pregabalin was based on its success in other pain conditions, such as nerve pain experienced by people with diabetes. The PRECISE trial has caused us to rethink its use in sciatica. We’re really excited that our trial was selected as a finalist in these prestigious awards, as this really helps us to share the important findings.”

Importantly, the findings of the PRECISE Trial will influence practice and change clinical guidelines ensuring the results of high quality clinical trials are meaningfully used to improve outcomes for patients. 

Australian Placental Transfusion Study

Is there harm or benefit in delayed clamping of the umbilical cord in preterm infants?

The first evidence, published in the American Journal of Obstetrics and Gynecology, indicating that delayed umbilical cord clamping might have benefits for preterm infants and their mothers came in 2017 from a systematic review of randomised trials in nearly 3,000 preterm babies. 

The largest of these trials was the Australian Placental Transfusion Study involving nearly 1,600 babies born more than ten weeks early in 25 hospitals in seven countries.

In that trial, led by the University of Sydney’s NHMRC Clinical Trials Centre, doctors either clamped the cord within ten seconds of birth or aimed to wait 60 seconds before clamping.

“Ten years ago, umbilical cords were routinely clamped quickly after a preterm birth and the baby was passed to a paediatrician in case s/he needed urgent help with breathing,” says University of Sydney Professor William Tarnow-Mordi, who led the trial, published in the New England Journal of Medicine.

“But we now know that almost all preterm babies will start breathing by themselves in the first minute, if they are given time.”

“As a result of the Australian Placental Transfusion Study, we can say that delayed clamping of the umbilical cord by 60 seconds saves preterm babies’ lives. It also means that fewer babies get blood transfusions, and there is no increase in complications for mother or baby.”

Why does delayed clamping benefit preterm babies?

“First, babies may get extra red and white blood and stem cells from the placenta, helping to achieve healthy oxygen levels, control infection and repair injured tissue,” says Professor Tarnow-Mordi.

“Second, they get more time to start breathing on their own, helping them avoid invasive procedures.

“Worldwide, the benefits are huge because 15 million babies are born preterm each year. Fast, effective treatments that cost nothing are rare, but the evidence shows that delayed cord clamping is one of them.”

“We estimate that for every thousand very preterm babies born more than ten weeks early, delayed clamping will save between 20 and 100  additional lives compared with immediate clamping,” said the University of Sydney’s Associate Professor David Osborn, the systematic review’s lead author and a neonatal specialist at Royal Prince Alfred Hospital.

“This means that, worldwide, using delayed clamping instead of immediate clamping can be expected to save between 11,000 and 100,000 additional lives every year.”

Research co-author and Professor of Obstetrics and Gynaecology, Dr Jonathan Morris said:

“This intervention is simple and can be applied in every setting where babies are born across the world. This research will save lives.”

For babies who don’t need immediate resuscitation the message is simple – wait a minute!

Information for parents

Parents who want to know more are encouraged to visit the NHMRC Clinical Trials Centre website at http://www.ctc.usyd.edu.au  or Miracle Babies Foundation at https://www.miraclebabies.org.au/ for frequently asked questions about the Australian Placental Transfusion Study. 

Parents in Australia who need support can contact Miracle Babies Foundation 24 hour helpline at 1300 622 243.

Related news coverage

Sydney Morning Herald: Delayed clamping of umbilical cord could save thousands of premature babies' lives: study

ABC: Premature babies: Simple procedure by Australian doctors could save thousands of lives each year