Obstetric researchers honoured with inaugural clinical trial award

New research revealing women are better off waiting than being induced if their waters break early has won the University of Sydney’s Professor Jonathan Morris the inaugural Australian Clinical Trials Alliance award for the most outstanding investigator-driven clinical trial of 2015.

Published in The Lancet, Professor Morris’ ten-year international trial of more than 1800 pregnant women in 11 countries is set to significantly improve the outcomes in pregnancies where women’s waters break early, which occurs in 40 per cent of preterm deliveries.

When this rupture occurs before 34 weeks gestation, women are not generally induced as the complications of prematurity outweigh the risks, and by 37 weeks the infant is considered to have reached full term. But medical opinion has been split on whether women whose waters break in between 34 and 37 weeks should give birth immediately, or wait until the baby is more mature. Most recently it has been in favour of inducing labour, however premature babies spend more time in intensive care units and more mothers have to have caesareans.

Professor Morris’ game-changing research has now determined that babies are better off waiting in utero through this twilight period until the baby is full term at 37 weeks, rather than being induced immediately.

"What's become apparent is these last few weeks of gestation are really critical - they greatly benefit the brain and lung development of babies,” said Professor Morris, who is the director of the Kolling Institute for Medical Research.

“Given the recent increasing evidence of a lifelong risk of adverse outcomes in babies born even slightly prematurely, we felt it was important to determine whether the current treatment, which was resulting in babies being delivered early because of concerns over infection, was in fact supported by evidence.

“About 8 per cent of babies are born prematurely in Australia each year, and even those born between 34 and 37 weeks have higher chances of metabolic disease, cardiovascular disease, obesity, decreased respiratory function and impaired learning.”

The randomised controlled trial found babies whose mothers were placed on "expectant management" had significantly lower chances of respiratory distress and no difference in the rate of infection compared with those who were induced immediately.

These babies were likely to spend 50 per cent less time in neonatal intensive care after birth and 33 per cent less likely to require hospitalisation because of respiratory problems. The study also found that there was a reduced incidence of Caesarean section for mothers.

Professor Morris said there had not previously been any studies to support the case for immediate induction, despite UK guidelines being updated in 2010 to recommend the practice and US guidelines in 2013.

“This trial is an example of taking standard practice, testing it and coming up with a better outcome,” he said.

“Clinical trials are essential to inform best practice in health and we have an opportunity through Sydney Health Partners to embed clinical research within our health care system.”

The award was presented by Federal Health Minister Ms Sussan Ley on International Clinical Trials Day 20 May, 2016.