ResearchObstetricsThe Growth Restriction Intervention Trial: long-term outcomes in a randomized trial of timing of delivery in fetal growth restriction
Section snippets
The original trial
The methods have been fully described in the original trial reports.13, 14 In brief, during the recruitment period, November 1993 through March 2001, women with fetal growth restriction between 24-36 completed weeks, where an umbilical artery Doppler waveform had been recorded, and the responsible clinician was uncertain whether to deliver the baby immediately, were randomly allocated to either “deliver now” or “defer delivery” until it could safely be delayed no longer. Mode of delivery and
Results
The derivation of the study population is shown in Figure 1. Outcome was known for 302/376 (80%) children of mothers entered into the study and for 78% (269/343) survivors. Follow-up rates varied by country: Germany, 10/16 (63%); Italy, 25/101 (25%); The Netherlands, 51/71 (72%); Slovenia, 20/22 (91%); and United Kingdom, 188/234 (80%). Follow-up in survivors occurred at a median (range) age of 9.2 (6.8 to 12.5) years in the immediate delivery group and 9.4 (6.8 to 13.7) years in the deferred
Comment
The present long-term follow-up of the children originally randomly assigned to immediate or delayed delivery in the GRIT study has essentially shown no measurable differences in motor or intellectual disabilities between the groups. This is despite the considerable potential for damage from both arms of the trial–early delivery with all the risks of prematurity, and delayed delivery with the risks of prolonged hypoxemia in utero. The excess of stillbirths in the delay delivery group, and of
Acknowledgments
Study Manager: Heather Palmer (Nottingham);
Co-principal investigators: Jim Thornton, Neil Marlow, Dieter Wolke (United Kingdom);
Psychologists: Dawn-Marie Walker, Lisa Upstone, Harriet Gross (United Kingdom); Anja Kahnt (Germany); Vislava Velikonja (Slovenia); Sara Mazzotti, Elisa Mani (Italy); Petra Barneveld, Marit Bierman (Netherlands)
Trial Steering Committee: A. Grant (chair), P. Steer, D. Torgeson, S. Kitzinger, J. Hornbuckle, P. Steer, A. Salt, L. Murray
The GRIT study group: countries,
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Neurodevelopmental outcomes at five years after early-onset fetal growth restriction: Analyses in a Dutch subgroup participating in a European management trial
2019, European Journal of Obstetrics and Gynecology and Reproductive BiologyCitation Excerpt :In a systematic review performed by Levine et al. [47], 16 studies on neurodevelopmental outcomes among very preterm FGR in comparison with normally grown children were identified and 11 of these reported poorer neurodevelopmental outcome. Our cognitive results best correspond to those found by Walker et al. [43] and Schreuder et al. [40]. The studies that have reported poorer cognitive outcomes in study populations comparable to our study [39,41,42], were limited by very small numbers of patients.
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Sponsored by the United Kingdom Medical Research Council, which had no involvement with the study design, collection analysis, or interpretation of the data, the writing of the report, or the decision to submit the manuscript.
Cite this article as: Walker D-M, Marlow N, Upstone L, et al. The Growth Restriction Intervention Trial: long-term outcomes in a randomized trial of timing of delivery in fetal growth restriction. Am J Obstet Gynecol 2011;204:34.e1-9.
Acknowledgements and the countries, centers, and principal local investigators of the Growth Restriction Intervention Trial study group who participated in the 6- to 9-year follow-up are listed at the end of this article.