Sildenafil trial halted as babies die


mother holding baby's hand

A trial of sildenafil in pregnant women has been stopped after eleven babies died

The Amsterdam University Medical Centre has confirmed that it has stopped a study of the effect and safety of sildenafil which was given to pregnant women whose babies had a severe growth limitation.

The research was being carried out at 10 hospital sites in the Netherlands, with the aim of discovering whether sildenafil could improve blood flow through underperforming placentas.

All the pregnant women taking sildenafil for the trial had foetuses with severely limited growth, reports the Guardian.

But an independent committee which was supervising the research realised that more of the babies than expected had been born with issues with their lungs.

The trial had seen 93 women given sildenafil, and of their babies, 17 developed lung problems and 11 have died.

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. Of the treatment group, eight babies died from unrelated conditions, as did nine babies in the control group.

The Guardian reports that there has been no suggestion that the trial was “mishandled”.

The AMC said in a statement that the likelihood of lung blood vessel damage “appears to be greater and the chance of death after birth seems to have increased,” reports SBS.

“Previous studies have shown that sildenafil would have a positive effect on the growth of babies. The first results of the current study showed that there may be adverse effects for the baby after birth.”

It has been suggested that in the affected babies, pulmonary hypertension lead to low oxygen levels.

Research lead and gynaecologist Wessel Ganzevoort is reportedly “shocked” by the results.

“The last thing you want is to harm patients,” he told Dutch newspaper De Volkskrant.

Researchers conducting a similar trial in Canada have been notified and have suspended their research.

Another 10 to 15 pregnant women who took sildenafil as part of the trial are now waiting to discover if their baby has been adversely affected.

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