Abstract
Affecting approximately 10% of all pregnancies, intrauterine growth restriction (IUGR) based on impaired placental function, is the most important cause of perinatal mortality and morbidity. So far, there is no option for secondary prophylaxis once signs of insufficient transformation of the uterine arteries and mal-perfusion of the placenta are observed in the second trimester. Clinical management in pregnancies at risk is restricted to close monitoring and assessment for optimal timing of delivery. In a prospective randomised controlled trial patients eligible to such prophylaxis were given the organic nitrate pentaerythrityl-tetranitrate (PETN) (2x80 mg) or placebo (Schleussner et al, J Perinat Med 2014). We could demonstrate an absolute risk reduction of 39% (relative risk RR=0.609, 95% CI 0.367 to 1.011) for the development of IUGR or combined outcome (IUGR or death) (RR=0.615, 95% CI 0.378 to 1.000), respectively. To confirm these results a prospective randomised placebo controlled double-blinded multicentre trial was now initiated. Eligible patients are pregnant women at risk of developing IUGR meeting the inclusion criteria: abnormal uterine artery Doppler ultrasound, defined by a mean PI greater than 1.6, singleton pregnancy, informed consent and 190 to 226 weeks of gestation. Outcome measures: Primary efficacy endpoint: Development of IUGR (defined by birth weight < 10th percentile and impaired uterine perfusion identified by a mean PI of > 1.6). Key secondary endpoint(s): severe morbidity and mortality as composite of severe IUGR (< birth weight below the 3rd centile), intrauterine or neonatal death or placental abruption, birth weight below the 3rd, 5th and 10th centile, preterm birth and neonatal outcome. Patient enrolment will be started in May 2017. The proposed recruitment period is 18 month. Results are expected in 2019. On behalf of the PETN-Trial-DFG GR 1955 4-1 study group.
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