The Queensland study was looking into whether sildenafil reduced the risk of foetal distress in labour among women with full-term pregnancies and normally grown babies.
The Queensland study was looking into whether sildenafil reduced the risk of foetal distress in labour among women with full-term pregnancies and normally grown babies.

Baby deaths bring sudden halt to Queensland drug trial

A QUEENSLAND trial giving the erectile dysfunction drug Viagra to pregnant women has been suspended after the deaths of 11 babies in the Netherlands.

Professor Sailesh Kumar, of the Mater Medical Research Institute, said the Queensland study was looking into whether sildenafil, the generic name for Viagra, reduced the risk of foetal distress in labour among women with full-term pregnancies and normally-grown babies.

"Our trial uses much lower doses of sildenafil over a shorter period of time compared to the study in the Netherlands," Professor Kumar said in a statement issued by the Mater.

The Dutch trial was designed to investigate whether Viagra was useful in promoting the growth of severely underdeveloped babies in the womb.

Professor Kumar, based at the University of Queensland, said the Queensland study was looking into Viagra's use "in a very different context".

"Preliminary analysis of our study shows that there are benefits to using sildenafil in this context and we have not seen any similar complications nor any differences in other adverse outcomes between the two arms of our study," he said.

"As a precautionary measure, we have paused recruitment into our trial, until we have an opportunity to gain further information. We will update our patient information and consent forms in light of this new data before deciding the best way to proceed."

About 230 women had enrolled in the Mater trial, with another 200 expected to be recruited before the study was halted.

The Dutch trial was looking into possible beneficial effects of increased blood flow to the placenta in mothers whose unborn babies were severely growth retarded.

Professor Kumar did not return The Courier-Mail's phone calls today.



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