Recommencement of the RIDSTRESS (Sildenafil/Viagra) trial

Recommencement of the RIDSTRESS (Sildenafil/Viagra) trial

Mater Research Professor Sailesh Kumar:

“Following detailed review, Mater is pleased to announce recruitment for the RIDSTRESS (Sildenafil) study has recommenced.

“Recruitment for this study was temporarily paused after an unrelated trial in the Netherlands—which used Sildenafil in pregnancy for the treatment of severely growth-restricted pre-term babies—revealed an increase in neonatal deaths in the Sildenafil group.

“The study investigators, with the assistance of an independent Data Safety and Monitoring Committee, reviewed all data from the Mater study and are pleased to confirm that there are no differences in adverse outcomes between the Sildenafil and Placebo groups. Importantly, there were no similar adverse outcomes as reported by the Dutch investigators. Furthermore, the previously noted beneficial impact of Sildenafil persists.

“The investigators wish to stress that the RIDSTRESS study is very different to the Dutch trial. The Mater study is in women with full term pregnancies with normally grown babies with the purpose of assessing if Sildenafil reduces the risk of fetal distress in labour. The RIDSTRESS study uses much lower doses of Sildenafil over a shorter period of time compared to the study in the Netherlands.

“Following this detailed review of the study data to date, both the Mater Human Research Ethics Committee and the Data Safety and Monitoring Committee are happy to approve recommencement of the RIDSTRESS study.

“The safety of both participants and their babies is of paramount importance for Mater and close monitoring of outcomes will continue until the study is completed.”

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