The TRUFFLE monitoring protocol for early-onset fetal growth restriction: A clinical effectiveness study.

Abstract

Introduction: The randomized control Trial (RCT) of Randomized Umbilical and Fetal Flow in Europe (TRUFFLE study) established its clinical efficacy for monitoring preterm fetal growth restriction (FGR). The objective of this study was to assess the clinical effectiveness of this protocol in a routine clinical setting with regards to the clinical outcomes, both overall and stratified by gestational age at FGR diagnosis.

Material and methods: This is a retrospective cohort study of singleton pregnancies with preterm FGR between January 2013 and July 2024 in a tertiary Fetal Medicine Unit. FGR was defined as an estimated fetal weight or abdominal circumference <10th centile with an elevated umbilical artery pulsatility index >95th centile. Main outcomes collected included perinatal survival, interval from diagnosis to delivery, and delivery indications.

Results: 171 pregnancies met inclusion criteria. The median (IQR) gestation at FGR diagnosis and birth was 27⁺⁶ (25⁺⁵-29⁺⁴) and 30⁺³ (28⁺⁰-32⁺⁴) weeks, respectively. Overall intact neonatal survival was 90.6%, with the rate of stillbirth and neonatal death being 2.9% and 5.8%, respectively. FGR diagnosis prior to 26 weeks was associated with a three-fold longer interval to birth compared with FGR diagnosis at 26⁺⁰-29⁺⁶ and ≥30 weeks (median of 31.0 vs. 10.0 and 14.0 days; p < 0.001). Below 32 weeks, the predominant indication for elective birth was abnormal computerized CTG with low short-term variation (STV). Beyond 32 weeks' gestation, abnormal umbilical artery Doppler and maternal indications such as preeclampsia were more frequent.

Conclusions: The TRUFFLE monitoring protocol is clinically effective in managing early-onset FGR outside a trial environment, achieving comparable perinatal outcomes to the original RCT. Routine integration of both Doppler and cCTG monitoring is crucial for optimal timing of birth with early FGR. Further research is needed to explore the benefits of more frequent or remote fetal monitoring.