[ad_1]
The UMC of Amsterdam, headquarters of the AMC, has terminated a multicentre, placebo-controlled study on the effects of sildenafil in pregnant women with a delayed growth fetus. An interim analysis has shown that the drug can increase the risk of newborn death. The 183 women enrolled so far – and half of them having taken sildenafil – have been approached and know if they have taken sildenafil or a placebo.
Previous studies have shown that sildenafil (which is also on the market under the name of Viagra, among others) may improve the prognosis of the child in case of severe fetal growth retardation caused by placental insufficiency . The drug would improve the blood flow in the placenta and thus the growth of the fetus. Sildenafil therapy in the prognosis of dismal Early research on the restriction of fetal development in fetuses (STRIDER) has been put in place to find out. In this paper, women whose unborn child had an early pregnancy of 25 to 30 weeks (25 to 30 weeks) had 25 mg of sildenafil or a placebo three times a day until birth. According to the study's description on clinicaltrials.gov, no risk was to be expected, but unexpected risks associated with the drugs could not be excluded.
According to a spokeswoman for the AMC, the sildenafil group consisted of 93 women. Seventeen of their children had lung disease, eleven of whom died. In addition, eight other babies died without this condition. The placebo group included 90 women who received three babies with this lung disease. They are not dead, but nine other babies (without lung disease) have done it. According to the spokesman, this concerns the increase in blood pressure in the pulmonary vessels, which has not yet been established as being caused by sildenafil; This must be obvious as a result of further research. Sildenafil is also indicated for the treatment of pulmonary hypertension
No positive effects have been found. Mothers have experienced no adverse effects as far as known. A similar study in Canada was stopped after contact with Dutch researchers, two others had already been completed. The CMA report indicates that researchers expect that the use of sildenafil in case of slower growth – in some places this will happen outside of the academic context – s & # 39; s; 39; stop.
see also
Source link
