Viagra trial for pregnant Dutch women shut down after 11 babies die

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Professor Zarcko Alfirevic, from the University of Liverpool, who led part of the United Kingdom research into sildenafil in pregnancy that found no benefit in terms of improving baby growth, said: "This finding in the Dutch study is unexpected".

And up to 15 women who took the medication face an agonizing wait over their babies' condition as they have yet to give birth.

Half of the 183 mothers in the trial had been treated with sildenafil while the other half were treated with a placebo.

"In light of these results from Holland, we are going to go back and discuss the matter with them and make a decision over the next one or two weeks".

Professor Zarko Alfirevic from the University of Liverpool, who led part of the United Kingdom research into sildenafil in pregnancy, said that the findings in the Dutch study were "unexpected".

After they were born, 11 of the babies whose mothers had been given sildenafil developed a form of high blood pressure in the lungs, which killed them, the researchers said.

"The researchers found no positive effect for the children on other outcomes", the AMC said. Despite the shocking and unpredicted results some scientist still hold out hope the drug can be used in a way that can assist in healthier babies. However, they also did not document any benefits. Based on these findings, the study stopped immediately. The team did not observe any negative effects of the drug, except for a decrease in the blood flow from placenta to fetus through a shunt between the placenta and fetus called the ductus venosus.

The women in the drug-trial study had babies that were highly underdeveloped in the womb. Six babies were born with the lung disorder and survived. Three babies from the placebo group developed the same lung condition as those in the sildenafil group.

Eleven in the sildenafil group died from lung complications.

Sailesh Kumar, from the University of Queensland and the Mater Research Institute, said his study aimed at reducing foetal distress during childbirth and used a much lower dose of Sildenafil and for a much shorter period.

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The company also issued a statement Wednesday noting that it did not fund or provide medication for the trial. The prognosis for each of the unborn babies was poor.

Dutch researchers say they will now examine the available data and monitor the development of the children who have taken part.

Dr. Katie Groom, associate professor of maternal and perinatal health at the University of Auckland and the chief investigator of the Australia and New Zealand trial, said these lung problems and deaths were not seen there, nor in the United Kingdom, although they are reviewing all of the cases in the trial to be sure.

Health Canada said in an emailed statement that it has contacted the University of British Columbia concerning the Canadian trial. The trial there was started in 2017 and was still enrolling patients at three locations until it was halted after news of the deaths in the Netherlands. "We had made peace with the fact that our daughter Olivia died eight days after birth", she told the NOS news channel.

In total, 93 women were given sildenafil and 90 were given a dummy drug or placebo.

The study had already been conducted in New Zealand and Australia, according to Amsterdam Universitair Medische Centra (University Medical Center), which headed the latest trial. Viagra dilates the blood vessels and is sometimes prescribed for people with high blood pressure. "All adverse effects occurred after birth".

"Viagra is indicated for the treatment of the symptoms of erectile dysfunction in adult men (aged 18 years and over)".

Patients had even heard about the study and had asked him to prescribe it, he said.

Led by Amsterdam University Medical Centre, the study involved 93 women being given the drug.

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