The search stopped after the death of the babies

The University Hospital Amsterdam UMC immediately stopped a major investigation into the effect of sildenafil drug on placentas and the growth of too small fetuses. The reason is the death of too many newborns whose mothers participated in the study.

Of the 93 pregnant women who took sildenafil in the study, 19 babies died after delivery. Eleven of these deceased babies had severe lung disease; six others did not have this lung disease. Ninety-nine of the ninety mothers who took a placebo died. Three of these ninety babies also had lung disease, but did not die. The chance that the difference can be explained by chance is very small.

Sildenafil, also known as viagra, is a licensed drug that dilates certain blood vessels and is prescribed for erection problems and increased blood pressure in the lungs in adults . The risk of death was unknown according to Amsterdam UMC. It is already used in pregnant women with fetuses too small in other countries and has been tested on animal placentas.

The study involved fetuses with significant growth retardation at the beginning of pregnancy. They have an increased chance of being born prematurely and dying in the womb or after birth. This stunting is caused by the mother's placenta (which feeds the baby) not working properly. Researchers around the world have been wondering for some time whether such a weak placenta can be strengthened. A fetus weighs on average about 330 grams after 20 weeks, but these fetuses weigh only 165 grams.

Rare deviation

Eleven Dutch hospitals participated in the study (the eight academic centers and Isala de Zwolle, the Máxima Medical). Center in Veldhoven and MCL in Leeuwarden) under the supervision of Amsterdam UMC. The study began in January 2015 and was to be completed in the fall of 2017, but it was only halfway. The researchers wanted to test the drug for 354 placentas, but found only 183 mothers with a fetus too small, who also wanted to participate in the study. This is a rare anomaly.

If the researchers had suspected that babies would die, they would never have started, says Amsterdam UMC, when they were asked. "We realize that this is very bad for the families involved." The researchers are excited. </ P> <p> As soon as the committee evaluates the data in the interim report that twice as many babies died in the sildenafil group, the researchers stopped The study immediately called all the parents involved and told them what had happened. "They were also told if they had received sildenafil or a placebo – participants in the study Study never know.

There were fifteen mothers who were still taking the drug until Thursday and whose child had not yet been born. </ P> <p> To what extent did their pregnancy progress? is still unknown

Patients must sign for the risks they are involved in researching a drug.However, they must first be well informed of these risks.They also receive the standard phone number from an expert who does not st not involved in the study to ask questions.

According to Marcel Kenter of the LUMC, who was not associated with this research but who trains many researchers and previously overseen medical-ethical review committees, he is "very sad that this has so much malfunctioning. "Probably, these risks were still unknown to researchers, things rarely go wrong, but risks can never be totally excluded."