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A woman who took part in a Dutch drug trial in which 11 babies died spoke of a "swirl" of emotions before enlisting.
Lana Huf-Germain (38) was one of 183 pregnant women who participated in a program to test whether the drug Sildenafil, which is sold under the brand name Viagra, would stimulate the growth of unborn children in the womb.
Women were informed Sunday that the trial, which began in 2015, was being discontinued due to the high number of deaths among babies born to mothers who took the drug.
Huf-Germain, whose daughter was born prematurely two years ago but is now in good health, said that he had been told
Between 10 and 15 women were still participating in the trial until the end of the year. to last Thursday and are now facing a terrifying wait to know if their unborn children have been affected.
Huf-Germain said that she did not remember being informed of any risk to her child at the start of the trial, but such was the desperation of the women involved that few would have understood the possible consequences .
She told the Guardian : "At the 20-week scan, they said that my daughter was too small and we had to go to the hospital.One of the first things we heard was that they were doing this research and they said it might be helpful to us.
"A doctor came to tell us what Viagra does and it still seems very plausible." So we said & # 39; yes, of course, let's go. "I asked my husband," Did they tell us the risks? "
" We were in a whirlwind. I can not even remember what I signed. She could have said something. But it was not so clear that we said, "Let's think about this." We were: "Let's do it and let's do it."
Huf-Germain added: "In all fairness, they did not know, as far as I know, about the risks. That's why I can not blame them. It's easy for me to say because my daughter is alive and I'm fine. If it had worked, they would be heroes.
"My husband needs therapy after that, he says," We will never do any more testing. "People are going crazy about it, I'm more on the doctors side, it's horrible for parents who are still pregnant now and who have caught it.It's a whole different ball game. "
The research was conducted in 10 hospitals across the Netherlands and involved women whose the placentas were underperforming.
Sildenafil, which dilates blood vessels, is commonly used for erectile dysfunction in men. and is prescribed for people with high blood pressure. It is sold by Pfizer as Viagra, but the pills used in the study were not produced by the pharmaceutical giant.
Researchers informed women that common side effects were dizziness, pink cheeks, headaches, and increased badual appetite.
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The hope, supported by experimental research on rats, had been that the drug would promote a better flow of blood through the placenta, promoting the growth of the child .
had unborn babies whose growth had been severely restricted in the uterus. The prognosis of children, due to a lack of available therapy, was considered poor as a result.
A total of 93 women received the drug in the trial, led by Amsterdam University Medical Center (UMC). Seventeen babies developed lung problems and 11 died. Of the 90 women in a control group who took a placebo, three had children who developed the same lung problems, but no babies died of diseases that could be related to sildenafil. . Nine babies died of independent problems
A spokeswoman for the UMC of Amsterdam said that women who were waiting to know if their child was affected had been counseled, just like those whose children were dead.
It is thought that the drug may have caused high blood pressure in the lungs, resulting in oxygen deficiency for babies. There is no indication that the trial was mistreated, and a spokesman said that the entire risk was on a consent form.
Huf-Germain said: "I think that in hindsight you make the decision, you have the impression that you have operated the switch – dead or alive. C & # 39; That's why people are angry, you feel responsible for the death of your child. "
An essay in the UK, the results of which were published last December, offers no compelling evidence of Efficacy of the drug or its risk to patients. Dutch researchers advised UK women to consider the results of their study. – Guardian
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