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Pregnant women and their unborn babies can look forward to a brighter future, with the risks of fetal distress in the spotlight of Professor Sailesh Kumar’s research.
Fetal distress can occur when a baby does not receive enough oxygen during labour, which can result in emergency delivery by caesarean section. It can also be associated with poor neonatal outcomes, even in previously uncomplicated pregnancies. Lack of oxygen during labour can cause brain injury in babies leading to significant early and late complications including cerebral palsy.
Senior Specialist in Maternal and Fetal Medicine/Obstetrics and Gynaecology at Mater Mother’ Hospital Professor Kumar wants this to change.
“In an earlier world-first trial of 300 women at term, we showed that Sildenafil Citrate compared to placebo halved caesarean and instrumental birth rates due to fetal distress. However, while this is a significant finding, the trial was not large enough to demonstrate that Sildenafil improved neonatal outcomes,” Professor Kumar said.
“In the forthcoming Phase 3 trial we will evaluate if Sildenafil improves neonatal outcomes by reducing the risk of fetal distress during labour. These is a major area of unmet need.”
The Medical Research Future Fund (MRFF) for the Rare Cancers, Rare Diseases and Unmet Need (RCRDUN) scheme, awarded Professor Kumar $3.42 Million for a large Australia wide study: Can intrapartum SildEnafil safely Avert the Risks of Contraction-induced Hypoxia in labour? iSEARCH – a pragmatic Phase 3 Randomised Controlled Trial.
In partnership with Mater Research-University of Queensland, National Health and Medical Research Council (NHMRC) Clinical Trials Centre, the Stillbirth Centre for Research Excellence and the Australia Cerebral Palsy Alliance, the trial will run over four years, in 16 Australian hospitals and 3200 women, in spontaneous or induced labour at term, to test if compared to placebo, does Sildenafil reduce the risk of fetal hypoxia and thus improve neonatal outcomes. This trial will commence later this year.
“This MRFF grant is so important for us to be able to take forward the results of our earlier work and hopefully develop a reliable preventative treatment for this devastating birth complication,” said Professor Kumar.