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Trial of Umbilical and Fetal Flow in Europe

Go to the TRUFFLE website

How to decide the best timing of delivery in preterm pregnancies complicated by intrauterine growth restriction

Optimal management of severe early fetal growth restriction is one of the greatest challenges in Obstetrics. In case of abnormal fetal monitoring obstetricians are often uncertain when to deliver these babies and how to balance between the complications of extreme preterm delivery and the risks of prolonged intrauterine exposure to malnutrition, hypoxia and the risk of death. Prospective observational research by the study group and others has provided evidence that Doppler measurement of the fetal ductus venosus (DV) maybe the best parameter to guide timing of delivery in these pregnancies.However this hypothesis needs further evidence.

The objective of this multi-centre randomised protocol, approved by the Lancet, is to determine which technique results in optimal timing of delivery of early preterm growth restricted infants: DV measurement (two different cut-offs - 1. mild or 2. severe abnormality- will be tested) or traditional monitoring based on 3. cardiotocography (STV). Criteria for inclusion aim at selecting a group of early and severe growth restricted fetuses. Randomisation will assign fetuses to the three branches.

Outcome measures and analysis
The primary outcome is normal neurological outcome at 2 years corrected age, without minor or major sequelae, examined by Griffith's Mental Developmental Scale. Two years is the earliest age to evaluate the infant development. The hypothesis of the study is that among preterm growth-restricted infants, timing delivery when the fetal DV is just marginally or severely abnormal,i.e. before the onset of severe fetal hypoxemia, increases the rate of normal infant neurological outcome compared with timing of delivery based on severe changes in fetal heart short-term variation.

The study will determine if timing delivery based on changes of fetal haemodynamic modifications monitored by venous Doppler velocimetry,where they precede a non-reassuring fetal heart rate pattern, is more effective than using computerised fetal heart rate monitoring.