Sildenafil (Viagra) trial

Mater Research Institute—University of Queensland (MRI-UQ) Professor Sailesh Kumar discusses the findings of a recent trial in the Netherlands using Sildenafil, reported in the media today:

"Media outlets have reported today that a trial in the Netherlands, investigating the use of Sildenafil (Viagra) in very pre-term babies with severe fetal growth restriction, has been halted. 

"This trial is part of an international consortium with several separate studies taking place in different parts of the world.  In Australia, New Zealand and the UK, similar studies have been concluded and have shown no benefit to using Sildenafil in very pre-term babies where the aim is to use Sildenafil to help the babies to grow.  Importantly, the UK and Australia/New Zealand studies did not show the specific complication reported in the Dutch study and they didn’t show any other poor outcomes.

"At Mater, the trial we are undertaking currently is investigating Sildenafil in a very different context.  We are researching the use of Sildenafil in women with full term pregnancies with normally grown babies to see if it reduces the risk of babies becoming distressed in labour.  Our trial uses much lower doses of Sildenafil over a shorter period of time compared to the study in the Netherlands.

"Early results of our study show that there are benefits to using Sildenafil in this context and we have not seen any similar complications nor any differences in poor outcomes between the two arms of our study.

"With any trial we always take the utmost caution, so as a precautionary measure, we have paused recruitment into our trial, until we have an opportunity to gain further information before deciding the best way to proceed."