Pentaerithrityl tetranitrate (PETN) for secondary prevention of intrauterine growth restriction (PETN Trial)

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Affecting 10% of pregnancies, intrauterine growth restriction (IUGR) is the most important cause of perinatal mortality and morbidity. IUGR is defined as the pathologic restriction of intrauterine supply and the failure of the fetus to achieve its growth potential. Furthermore intrauterine malnutrition causes lifelong consequences as developmental origin of adult diseases. In the mother, IUGR is associated with vascular pathology, impaired placentation and the failure of decidual spiral artery remodelling, leading to impaired placental perfusion. Consequently, abnormal uterine flow, identified by duplex sonography at mid gestation, as well as maternal conditions associated with impaired vascular health, including previous IUGR, signifies the risk of developing IUGR during pregnancy. NO-donors as pentaerithrityl tetranitrate (PETN) reduce the impedance in the uteroplacental vessels and have been demonstrated to possess protecting effects on the endothelium. A randomized mono-center pilot study revealed a 38% relative risk reduction for IUGR or perinatal death (CI 95%: -1% to 63%) and a 70% reduction of preterm birth before 32 weeks of gestation (CI 95%: 9% to 92%) in the PETN intervention group. These data strongly suggest that PETN is a feasible drug to significantly improve the outcome in pregnancies compromised by placental insufficiency. To confirm the effects of PETN on pregnancy outcome 325 pregnant women at risk to develop IUGR will be enrolled into a prospective, multicenter, randomized, double-blind, placebo controlled, parallel group, interventional trial.