Research
Obstetrics
The Growth Restriction Intervention Trial: long-term outcomes in a randomized trial of timing of delivery in fetal growth restriction

Presented at the 56th Annual Scientific Meeting of the Society of Gynecological Investigation, Glasgow, Scotland, United Kingdom, March 18-21, 2009.
https://doi.org/10.1016/j.ajog.2010.09.019Get rights and content

Objective

The Growth Restriction Intervention Trial found little difference in overall mortality or 2-year outcomes associated with immediate or deferred delivery following signs of impaired fetal health in the presence of growth restriction when the obstetrician was unsure whether to deliver. Because early childhood assessments have limited predictive value, we reevaluated them.

Study Design

Children were tested with standardized school-based evaluations of cognition, language, motor performance, and behavior. Analysis and interpretation were Bayesian.

Results

Of 376 babies, 302 (80%) had known outcome: either dead or evaluated at age 6-13 years. Numbers of children dead, or with severe disability: 21 (14%) immediate and 25 (17%) deferred groups. Among survivors, the mean (SD) cognition scores were 95 (15) and 96 (14); motor scores were 8.9 (7.0) and 8.7 (6.7); and parent-assessed behavior scores were 10.5 (7.1) and 10.5 (6.9), respectively, for the 2 groups.

Conclusion

Clinically significant differences between immediate and deferred delivery were not found.

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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    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.

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