Stop prescribing sildenafil for fetal growth restriction: ST
The STRIDOR consortium has strongly recommended that sildenafil should NOT be prescribed for fetal growth restriction (FGR) outside the setting of clinical trials. The article has been published in the journal Ultrasound in Obstetrics & Gynecology banner.

No therapy exists for FGR due to poor placental function. Current management centres around the timing of delivery, balancing the risks of intrauterine demise with those of prematurity due to indicated early birth. Pharmacological intervention to improve placental function may be a way to overcome this dilemma.

The international Sildenafil TheRapy In Dismal prognosis
Early-onset intrauterine growth Restriction (STRIDER)
Consortium was established in 2011 as a group of
investigators committed to exploring the effects of the
sildenafil, for the treatment of FGR in the first randomized placebo-controlled trial in humans.

Previously, animal and preclinical studies, as well as a small case-control series in humans, supported the hypothesis that this selective vasodilator may enhance uteroplacental blood flow and, hence, ameliorate impaired fetal growth and improve fetal wellbeing, allowing safe prolongation of pregnancy.

Over the last week there has been significant global interest in media reports following the suspension of the Dutch STRIDER trial. The decision to halt this trial was made following a planned interim analysis conducted by an independent data and safety monitoring committee, which concluded the following:-

• There was a potential signal of harm relating to an increased incidence of persistent pulmonary hypertension of the newborn and a non-significant trend towards an increase in neonatal death (but not stillbirth).

• There was likely futility of the trial to show a significant beneficial effect in the primary outcome: a composite of mortality and major neonatal morbidity at hospital discharge.

Given these two facts of possible (but currently
unproven) harm and likely lack of benefit, the decision
was made to stop the trial, to allow detailed review and
validation of the findings before any further exposure of
women and their fetuses to sildenafil.

These previous trials, using almost identical methods, did not find any beneficial effect of sildenafil therapy in FGR, but also found no evidence of an association with persistent pulmonary hypertension of the newborn or neonatal death.
These findings are of concern and are being taken very seriously.

The STRIDER Consortium is currently exploring the data fully to elucidate the mechanisms of the findings within the Dutch trial.

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