Pentaerithrityl Tetranitrate (PETN) for Secondary Prevention of Intrauterine Growth Restriction
Status:
Active, not recruiting
Trial end date:
2021-10-31
Target enrollment:
Participant gender:
Summary
Approximately 10% of all pregnancies experience mal perfusion of the placenta resulting in
fetal growth restriction (FGR) of the fetus. FGR 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 FGR. So far, there is no treatment option for pregnancies complicated by FGR and the
clinical management is restricted to close monitoring, assessing for the optimal time point
of delivery of the fetus threatened by intrauterine death. In a pilot study a risk reduction
of 38% for the development of severe FGR and FGR or death could be demonstrated by giving the
organic nitrate pentaerithrityl-tetranitrate (PETN) to patients recognized at risk for FGR by
impaired uterine artery Doppler at mid gestation (Schleussner, 2014). To confirm these
results this prospective randomized placebo controlled double-blinded multicentre trial, was
initiated.