Deaths stop Qld research

Overseas

A QUEENSLAND study into reducing foetal distress during childbirth through the use of Viagra has been paused after the use of the same drug resulted in the death of 11 babies in The Netherlands.

Mater Research Institute professor Sailesh Kumar said the study at the Mater Mother’s Hospital used a much lower dosage of Sildenafil, which is sold as Viagra and dilates blood vessels in the pelvis, compared to the Dutch study.

The Queensland study was used over a significantly shorter time frame and for different reasons, but it had been paused as a precautionary measure while he gathered more information from the Dutch researchers, he added. “Our study is in a very completely different context,” Mr Kumar said yesterday.

“We are using Sildenafil in women with full-term pregnancies who are appropriately grown. These are babies at 37 and beyond weeks.

“Our primary aim is to see if it reduces the risk of a baby becoming distressed in labour.”

The Dutch study, which started in 2015, looked at possible beneficial effects of increased blood flow to the placenta in mothers whose unborn babies were severely underdeveloped.

Eleven babies of mothers using the medication died.

When the overseas trial was stopped on Monday, roughly half of the 183 participating pregnant women were taking Sildenafil, the Amsterdam University’s Academic Medical Centre said in a statement.

Prof Kumar said a decision on the future of the Queensland study would be made within a fortnight and they have stopped recruiting mothers for their research.

He said about 240 women had taken part in the study and there were no adverse outcomes among those who had been taken Sildenafil.

“Our preliminary outcomes are promising,” he said.

“In light of these results from Holland, we are going to go back and discuss the matter with them and make a decision over the next one or two weeks.”