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

for the GRIT Study Group; the TRUFFLE Study Group

doi:https://doi.org/10.1002/uog.20354

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

DSpace/Manakin Repository

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

for the GRIT Study Group; the TRUFFLE Study Group

(2020) Ultrasound in Obstetrics and Gynecology, volume 55, issue 1, pp. 68 - 74

(Article)

Abstract

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 ... read more 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. © 2019 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of the International Society of Ultrasound in Obstetrics and Gynecology.

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Keywords: cardiotocography, ductus venosus, fetal growth restriction, monitoring, short-term variation, Pulsatile Flow, Humans, Randomized Controlled Trials as Topic, Pregnancy, Fetal Growth Retardation/mortality, Cardiotocography, Fetal Death, Ultrasonography, Prenatal, Umbilical Arteries/diagnostic imaging, Blood Flow Velocity, Female, Infant, Newborn, Pregnancy Outcome, Cohort Studies, Radiological and Ultrasound Technology, Obstetrics and Gynaecology, Radiology Nuclear Medicine and imaging, Reproductive Medicine, Research Support, Non-U.S. Gov't, Journal Article, Randomized Controlled Trial, Comparative Study

DOI: https://doi.org/10.1002/uog.20354

ISSN: 0960-7692

Publisher: John Wiley and Sons Ltd

Note: Funding Information: We gratefully acknowledge the support of Prof. Andy Vail, Centre for Biostatistics, University of Manchester for the provision of the relevant GRIT study data. This analysis was performed without funding. The original TRUFFLE study was partly funded by Grant Number 94506556, ZonMw, POBox 93245, 2509 AE Den Haag, The Netherlands. The GRIT study was funded by the United Kingdom Medical Research Council, a European Union Concerted Action and the Dutch Princess Beatrix Foundation. Funding Information: We gratefully acknowledge the support of Prof. Andy Vail, Centre for Biostatistics, University of Manchester for the provision of the relevant GRIT study data. This analysis was performed without funding. The original TRUFFLE study was partly funded by Grant Number 94506556, ZonMw, POBox 93245, 2509 AE Den Haag, The Netherlands. The GRIT study was funded by the United Kingdom Medical Research Council, a European Union Concerted Action and the Dutch Princess Beatrix Foundation. Publisher Copyright: © 2019 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of the International Society of Ultrasound in Obstetrics and Gynecology.

(Peer reviewed)