TRUFFLE 2 Study

The TRUFFLE-2 study is a multicentre individually randomised controlled trial involving 12 UK as well as European & International centres to identify the optimum method to time delivery of late preterm growth restricted fetuses or at risk of compromise in order to improve perinatal and long-term outcome. Potential participants are women with singleton non-anomalous ongoing pregnancies 32+0 to 36+6 weeks in whom a small for gestational age (SGA) baby is identified or one whose growth has slowed. Women become eligible for randomisation once signs of compromise are detected by Doppler cerebral redistribution and will be randomised to either immediate delivery or delayed delivery. Participants in the immediate delivery arm will be delivered or induction of labour commenced within 48 hours, allowing for administration of corticosteroids and infusion of magnesium sulphate as per local protocol and guidance. Whereas participants in the delayed delivery arm will be closely monitored using at least twice weekly Doppler and cCTG monitoring, or more frequently based on local centre protocols for clinical management. The sample size is 638 randomised patients, and we are currently on track to reach our target by the end of April 2025 with only 30 participants remaining."