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At the time they were treated, the mothers did not know which treatment they were receiving, which is standard in clinical trials.

The study was initiated in 2015, and conducted at 11 hospitals across the Netherlands.

It sometimes occurs because the mother has high blood pressure, uncontrolled diabetes or a condition called preeclampsia, he added.

There is no proven treatment for the condition, which can have serious impacts on the child, from miscarriage or neonatal death to neuro-disability and other lifelong health risks. However, they also did not document any benefits.

"The chance of a disease of the blood vessels of the lungs appears to be greater and the chance of death after birth seems to have increased".

"Based on these findings, the study stopped immediately", according to a statement from Amsterdam University Medical Center.

During the study, another 90 women took a placebo pill with no active ingredients. Apart from the 11 babies who died, 17 of them developed the lung problems and eight died of unrelated conditions. Eleven of these deaths were due to a possible lung disease, a form of high blood pressure in the lungs. Three babies with the lung disorder were born to women who were treated with the placebo, and they all survived.

"We are always very cautious so there will be a temporary stop to the recruitment in Queensland until we get further information", he said.

Researchers recommend at this stage that no one takes the drug to aid the development of unborn babies.

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.

"Pfizer was not involved in any aspect of this trial, and neither funded nor provided product for the trial", the statement said.

Prior to the experiments, the growth of each of the unborn babies was found to be limited and the prognosis viewed as poor. 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.

The center's researchers will analyze the now available data.

She has no concerns for the participants of a New Zealand and Australian trial. Stuff.co.nz reported in March on the results of a study that involved 122 Australian and New Zealand women, half of whom received sildenafil.

A similar trial conducted in Canada has been paused following the outcome of the Amsterdam trial. "Combining our results with those of the other trials and zooming in on subgroups might give more clarity", he says.

He revealed the results had also been shared with Canadian researchers working on similar trials.


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