A drug trial in the Netherlands on pregnant mothers has been put to an end after 11 babies died from lung disease, according to the press release issued on 23 July by the study leader – the Amsterdam University Medical Centre.
As a result, the researchers at the University of British Columbia have also suspended a clinical trial called STRIDER.
The study started in 2015, involving 11 hospitals. It was aimed at increasing the blood flow to the placenta in cases where unborn babies were critically undeveloped. This condition is called early intrauterine growth restriction (IUGR), increasing the risk of stillbirth or issues after the baby is born.
The Dutch trial involved 183 pregnant women, half of which received sildenafil (Viagra). At the moment, 15 women are close to giving birth, all waiting to see if the babies will live.
According to the Amsterdam University Medical Centre, the studies on sildenafil “showed a positive effect on the growth of babies. The first results of the current study showed that there may be adverse effects for the baby after birth.”
Dutch newspaper de Volkskrant reported that 19 babies born to mothers that received sildenafil died. Eleven of them had been born with lung conditions and didn’t survive. The trial had a group control that received placebo drugs – in that group nine babies died, but none of them had lung problems. The researchers believe that the drug might have caused the lung disorder.
The Canadian Trial Has Also Been Suspended
London School of Hygiene & Tropical Medicine’s pharmacoepidemiology professor, Stephen Evans, explains that the limited numbers of trials on pregnant women limited the knowledge of doctors and treatment for pregnant women, adding that:
“There have been other studies in this area, both involving preliminary work using animals and using pregnant women, and there was no indication that the treatment was dangerous based on previous research.”
The Canadian trial was supervised by the Head of the Division of Maternal-Fetal Medicine program at UBC, Dr. Kenneth Lim, stating the following:
“We are not aware of an increase in adverse outcomes among the 21 Canadian trial participants. We will contact the 20 other Canadian women who have already participated in the trial. As long as the trial is suspended, no further recruitment will take place.”
Doris’s passion for writing started to take shape in college where she was editor-in-chief of the college newspaper. Even though she ended up working in IT for more than 7 years, she’s now back to what he always enjoyed doing. With a true passion for technology, Doris mostly covers tech-related topics.