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Researchers at the University of British Columbia suspended a clinical trial that gave pregnant women an erectile dysfunction drug after 11 babies born to mothers enrolled in a similar Dutch study died. a lung disease
. give sildenafil to women suffering from a disease called early restriction of intrauterine growth (IUGR) in which the placenta does not provide enough food to the fetus, which increases the risk of stillbirth or problems after birth.
Sildenafil is well known by the brand name Viagra, improves blood flow, researchers had theorized that it could help increase the supply of nutrition to placentas in IUGR cases.
Amsterdam University Medical Center, which led the Dutch study, issued a press release Monday saying that the trial was suspended after an interim analysis revealed that the drug may be detrimental to babies after birth and had no positive effect.
Volkskrant reports that 90 women received sildenafil and 93 received a placebo during the Dutch trial. They say that 19 babies born to mothers who took the drug died, including 11 with a lung disorder. In the control group, nine babies died but none died as a result of a lung disorder. It is believed that Sildenafil may have caused this lung disorder
Dr. Kenneth Lim, Head of the Maternal and Fetal Medicine Program Division of the University of British Columbia, oversaw the Canadian trial
. On Tuesday, he learned of the report from the Netherlands late last week and immediately notified the Data Safety Monitoring Board of the study and the University Research Ethics Committee. from British Columbia
. We were very saddened and worried about learning this news, "he said in a statement sent by email.
"We are not aware of any increase in adverse outcomes among the 21 Canadian trial participants," Lim added.
A woman currently on trial was contacted and told to stop taking the pills she had received, which could have been either the drug or a placebo, according to Lim.
"We will contact the other 20 Canadian women who have already participated in the trial," said Lim, "As long as the trial is suspended, no further recruitment will take place."
The study recruited Mothers in Vancouver, Quebec and Montreal
"We are working with our international research partners in the Netherlands, the United Kingdom, Australia and New Zealand to better understand the cause. results in the Netherlands and how they relate to results reported by the UK and other researchers, which show no evidence of harm ". The UBC-led study was launched in 2017. It has received funding from the Canadian Institutes of Health Research and has been approved by Health Canada.
When Lim announced the trial, he said in a statement: "We have already done a small study that has shown promising results. "
" The growth of babies seemed to improve and no harm was identified, although the number of babies studied was small, "he said at the time. [19659016] d, s, id) {
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