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Dutch women who received Viagra to increase the growth of their unborn babies as part of a major clinical trial face an anxious expectation after the death of 11 babies.
The research, which was conducted at 10 hospitals in the Netherlands, included women whose placenta was not functioning properly and who were taking sildenafil, a drug sold under the brand name Viagra.
Viagra dilates blood vessels and is used for erectile dysfunction in women. Men also be prescribed for people with hypertension. It was hoped that with the support of experimental research in rats, the remedy would improve blood flow through the placenta, which would improve the baby's growth.
The growth of all babies of pregnant women who participated in the study I was severely limited in the uterus. As a result, the prognosis of children, due to lack of available treatment, was very poor. The study was canceled last week, when an independent committee that oversees the research found that more babies than expected were born with lung problems.
A total of 93 women received the drug as part of the study, led by the Medical Center of the United States. University of Amsterdam. Seventeen babies developed lung problems and since then, 11 have died
. Of the 90 women in the control group who received placebo, three developed lung problems, although no babies died. Now, between 10 and 15 women are hoping to find out if their children have been affected.
There is concern that the drug has caused pulmonary hypertension, which has resulted in babies receiving very little oxygen. Now, between 10 and 15 women are waiting to know if their children have been affected. "observe =" "data-observer-function =" loadLazyImg "/> Now between 10 and 15 women are waiting to know if their children have been affected. 19659011] In an interview with the Dutch newspaper De Volkskrant, the director of research, gynecologist Wessel Ganzevoort, commented: "We wanted to show that this is an effective way to promote baby's growth. I was stunned, the last thing he wanted was to harm patients "We have already informed Canadian researchers that they are doing a similar study. canceled their investigation. " The study began in 2015 and is expected to continue until 2020, with the participation of 350 patients. The hospital said: "A preliminary analysis of the Amsterdam University Medical Center, on the AMC website, has shown that sildenafil may be harmful to the baby after birth. Pulmonary blood vessels appear to be larger and the likelihood of death after birth seems to have increased. "The researchers found no positive effect for babies on other findings. All side effects occurred after birth. Based on these results, the study was immediately canceled. All participants were contacted and now they know if they took the drug or the placebo. " A study conducted in the United Kingdom, whose results were published last December, has not brought convincing evidence as to the effectiveness of the drug nor suggested that there was a risk for patients. Ganzevoort told De Volkskrant: "This was heard at conferences. Foreign colleagues have slipped that sometimes they have prescribed it, with good results. It has happened to me in my own office that pregnant women have asked me. If they had ordered it online? I do not know. Who can know? "In the Netherlands, physicians exercise reasonable care.The effectiveness and safety of the drug must first be proven by placebo-controlled studies before prescribing it. Exactly, this has been demonstrated once again. "
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