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Mothers were part of a clinical trial to evaluate the safety and efficacy of the drug
A experience with pregnant women in the Netherlands seems to have left terribly bad. According to The Guardian, a group of Dutch researchers suspended a clinical trial due to the death of 11 babies because of lung disease after their mothers were treated with sildenafil – Viagra – during pregnancy.
Mothers participated in a clinical trial to evaluate the safety and efficacy of the drug in infants with "severe fetal growth restriction" who were at risk . significant to be born dead or dying after birth.
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The Experience
Half of the 183 mothers in the trial had been treated with sildenafil, while the other half were treated with a placebo. By the time they received the drug, the mothers did not know what treatment they were receiving. This procedure is standard in clinical trial protocols.
The intention was that the drug, which improves the function of the blood vessels, will increase the function of the placenta, thus improving the growth of the fetus. However, the researchers found that the drug caused babies a kind of hypertension in the lungs: a disease in the blood vessels of the lungs that increased the risk of death after birth [19659005] Read also: 6-month-old babies are able to recognize faces and happy voices
According to the press release, 183 women have participated in the clinical trial in 11 cities in the Netherlands since 2015. Ninety-seven Three women were treated with the drug and 90 were treated with a placebo.
Painful Results
Of the 93 women who were treated with the drug, 19 babies died – 11 of them due to a lung disorder – ] Six other babies were born with pulmonary disorder and survived. In comparison, nine babies born to women treated with placebo died, but none of them suffered from a lung disorder. At the same time, 3 babies with lung disorders were born to women treated with placebo, and all survived.
"We wanted to show that it's an effective way to promote baby's growth, but it's the opposite. I am shocked, the last thing you want is to harm patients, "said lead researcher Wessel Ganzevoort, a gynecologist at the University of Amsterdam Medical Center, of the Dutch newspaper De Volkskrant.
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The statement from the medical center says that sildenafil is sometimes used to treat women whose babies do not seem to grow well. However, previous studies in the United Kingdom and New Zealand had determined that no significant factor had been found to indicate that the drug contributed to maintaining a stable newborn weight.
At present, Pfizer, the company The manufacturer of Viagra said that they did not participate in the medical tests. "The research is a study started by a researcher and Pfizer has no involvement in the lawsuit, "Dervila Keane told CNN, spokesperson for Pfizer.
Pregnancy is the most delicate stage of growth A study published in the middle of last year revealed that a high-fat diet during pregnancy was associated with Mental disorders and that in April this year it was discovered that infections during pregnancy have consequences on the cognitive development of the baby. 19659004]
Victor Román
This story was originally published in N + 1, adding science
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