After 11 babies die, Dutch halt Viagra pregnancy study

Belly of a woman in her 34th week of pregnancy

Belly of a woman in her 34th week of pregnancy

In spite of the trial's cancellation, around a dozen women are still waiting to see how the drug could affect their pregnancy, and are being closely monitored.

The trial, which began in January 2015 in 10 Dutch hospitals, was meant to treat women whose babies had life-threatening growth issues.

Now that it's no longer under patent, the drug is being explored by research companies as a wonder drug for a range of other conditions. Another 90 pregnant women were given a placebo.

Three of the women in the control group (n=90) also had babies who developed the same lung problems, but none have died from any condition which could be related to sildenafil.

So far about 200 women had been involved in the Queensland trial, with no adverse effects.

Ganzevoort said her team have notified a group of Canadian researchers carrying out a similar study to warn them of the results.

It appears the drug, which promotes blood flow, may have caused lethal damage to the babies' lungs.

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Of the 93 women who took sildenafil in the trail, 19 babies died - including 11 due to a possible lung disease thought to cause a form of high blood pressure in the lungs.

Earlier this week, Amsterdam University Medical Centre (UMC) announced an early end to a clinical trial testing a new use for the pharmaceutical sildenafil in the wake of newborn deaths. Growth restriction is diagnosed using ultrasound, but now the only medical treatment is closely monitoring the pregnancy and inducing birth when the risk of stillbirth is deemed high.

Kiwi researchers are disappointed after a Dutch trial where Viagra was being administered to pregnant women, has urgently been called off.

The women who participated in the trial were all carrying unborn babies whose growth was inhibited. One of the first things we heard was that they were doing this research and they said it might benefit us.

A spokesperson from the UMC told the media that the trial is believed to have followed the correct protocol, but they expect an external investigation to be launched into the matter. Its worldwide prevalence is 15.5%, comprising about 20 million children born each year, but the vast majority of low-birth-weight cases - 96.5% - are in developing countries. In 2012, they started an initiative to conduct five separate but very similar trials that would culminate in a meta-analysis.

But last week the trial was terminated when an independent committee overseeing the research found that more babies than expected were being born with lung problems. We contacted the one Canadian woman who was now in the trial, directing her to stop taking the drug or placebo. The drug dilates the blood vessels.

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