Comparative analysis of the 2-year outcomes in the GRIT and TRUFFLE trials

Objective: To explore the effect on perinatal outcome of different fetal monitoring strategies for early-onset fetal growth restriction (FGR). Methods: This was a cohort analysis of individual participant data from two European multicenter trials of fetal monitoring methods for FGR: the Growth Restriction Intervention Study (GRIT) and the Trial of Umbilical and Fetal Flow in Europe (TRUFFLE). All women from GRIT (n = 238) and TRUFFLE (n = 503) who were randomized between 26 and 32 weeks' gestation were included. The women were grouped according to intervention and monitoring method: immediate delivery (GRIT) or delayed delivery with monitoring by conventional cardiotocography (CTG) (GRIT), computerized CTG (cCTG) only (GRIT and TRUFFLE) or cCTG and ductus venosus (DV) Doppler (TRUFFLE). The primary outcome was survival without neurodevelopmental impairment at 2 years of age. Results: Gestational age at delivery and birth weight were similar in both studies. Fetal death rate was similar between the GRIT and TRUFFLE groups, but neonatal and late death were more frequent in GRIT (18% vs 6%; P < 0.01). The rate of survival without impairment at 2 years was lowest in pregnancies that underwent immediate delivery (70% (95% CI, 61–78%)) or delayed delivery with monitoring by CTG (69% (95% CI, 57–82%)), increased in those monitored using cCTG only in both GRIT (80% (95% CI, 68–91%)) and TRUFFLE (77% (95% CI, 70–84%)), and was highest in pregnancies monitored using cCTG and DV Doppler (84% (95% CI, 80–89%)) (P < 0.01 for trend). Conclusions: This analysis supports the hypothesis that the optimal method for fetal monitoring in pregnancies complicated by early-onset FGR is a combination of cCTG and DV Doppler assessment. Trial Registration: GRIT ISRCTN41358726 and TRUFFLE ISRCTN56204499.