P 53 Pentaerithrityl tetranitrate (PETN) for secondary prevention of intrauterine growth restriction (PETN-Trial) DFG GR 1955 4–1

Abstract

Aim Affecting approximately 10% of pregnancies, intrauterine growth restriction (IUGR), is the most important cause of perinatal mortality and morbidity. Impaired placental function determined by insufficient transformation of the uterine arteries and mal-perfusion of the placenta is the leading cause of IUGR. So far there is no treatment option for pregnancy complicated by IUGR and the clinical management is restricted to close monitoring, assessing for the optimal time point of delivery the fetus threatened by intrauterine death. In a prospective randomized controlled trial we could demonstrate a risk reduction of 39% (relative risk RR = 0.609, 95% CI 0.367–1.011) for the development of IUGR and IUGR or death (RR = 0.615, 95% CI 0.378–1.000) by delivering the organic nitrate pentaerythrityl-tetranitrate (PETN) to patients recognized at risk for IUGR by impaired uterine artery Doppler at mid gestation (Schleussner, 2014). To confirm these results a prospective randomized placebo controlled double-blinded multicentre trial was now initiated. Approach 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 190–226 weeks of gestation. Outcome measures Primary efficacy endpoint : Development of IUGR (defined by birth weight 1.6). Key secondary endpoint(s) : severe morbidity and mortality as composite of severe IUGR ( Results Patient enrollment will be started in July 2017. The proposed recruitment period is 18 month. Results are expected in the beginning of 2020.