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Queensland trial giving Viagra to pregnant women halted after Netherlands deaths Queensland trial giving Viagra to pregnant women halted after Netherlands deaths
(25 days later)
A Queensland study on reducing foetal distress during childbirth through the use of Viagra has been paused after the death of 11 babies in a clinical trial in the Netherlands using the same drug.A Queensland study on reducing foetal distress during childbirth through the use of Viagra has been paused after the death of 11 babies in a clinical trial in the Netherlands using the same drug.
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.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.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.
Eleven babies die after Dutch women given Viagra in drug trialEleven babies die after Dutch women given Viagra in drug trial
“Our study is in a very completely different context,” Kumar said on Wednesday.“Our study is in a very completely different context,” Kumar said on Wednesday.
“We are using Sildenafil in women with full-term pregnancies who are appropriately grown. These are babies at 37 and beyond weeks.“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.”“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.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.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 (AMC) said in a statement.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 (AMC) said in a statement.
Kumar said a decision on the future of the Queensland study would be decided within a fortnight and, in the meantime, they have stopped recruiting mothers for their research.Kumar said a decision on the future of the Queensland study would be decided within a fortnight and, in the meantime, they have stopped recruiting mothers for their research.
Gel, wand, belly, ultrasound: the moment life as I knew it endedGel, wand, belly, ultrasound: the moment life as I knew it ended
He said about 240 women had taken part in the study and there had been no adverse outcomes, comparing mothers who had taken a placebo pill and those who had been administered Sildenafil.He said about 240 women had taken part in the study and there had been no adverse outcomes, comparing mothers who had taken a placebo pill and those who had been administered Sildenafil.
“Our preliminary outcomes are promising,” he said.“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.”“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.”
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