GRIT 和 TRUFFLE 试验 2 年结果的对比分析。
Comparative analysis of 2-year outcomes in GRIT and TRUFFLE trials.
机构信息
Department of Obstetrics, Amsterdam University Medical Center, Amsterdam, The Netherlands.
Division of Child Health, Obstetrics and Gynaecology, School of Medicine, University of Nottingham, Nottingham City Hospital, Nottingham, UK.
出版信息
Ultrasound Obstet Gynecol. 2020 Jan;55(1):68-74. doi: 10.1002/uog.20354.
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. © 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.
目的
探讨不同胎儿监测策略对早发型胎儿生长受限（FGR）围产结局的影响。
方法
这是对两项欧洲多中心胎儿监测方法研究（GRIT 和 TRUFFLE）的个体参与者数据进行的队列分析：胎儿生长受限干预研究（GRIT）和欧洲脐带和胎儿血流研究（TRUFFLE）。所有在 GRIT（n=238）和 TRUFFLE（n=503）中于 26 至 32 孕周之间随机分组的女性均被纳入研究。根据干预和监测方法将女性分组：立即分娩（GRIT）或延迟分娩伴常规胎心监护（CTG）监测（GRIT）、仅计算机化 CTG（cCTG）监测（GRIT 和 TRUFFLE）或 cCTG 和静脉导管（DV）多普勒监测（TRUFFLE）。主要结局是在 2 岁时无神经发育障碍的生存情况。
结果
两项研究的分娩时孕周和出生体重相似。GRIT 和 TRUFFLE 组的胎儿死亡率相似，但 GRIT 组的新生儿和晚期死亡率更高（18%比 6%；P<0.01）。立即分娩组（70%（95%CI，61-78%））或 CTG 监测延迟分娩组（69%（95%CI，57-82%））的 2 岁时无损伤生存比例最低，仅接受 cCTG 监测的比例在 GRIT（80%（95%CI，68-91%））和 TRUFFLE（77%（95%CI，70-84%））中均有所增加，而接受 cCTG 和 DV 多普勒监测的比例最高（84%（95%CI，80-89%））（趋势 P<0.01）。
结论
该分析支持这样一种假设，即早发型 FGR 孕妇胎儿监测的最佳方法是 cCTG 和 DV 多普勒评估的结合。
试验注册
GRIT（ISRCTN41358726）和 TRUFFLE（ISRCTN56204499）。© 2019 作者。超声在妇产科由 John Wiley & Sons Ltd 代表国际妇产科超声学会出版。
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