Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT)

K E Boers, S M C Vijgen, D Bijlenga, J A M van der Post, D J Bekedam, A Kwee, P C M van der Salm, M G van Pampus, M E A Spaanderman, K de Boer, J J Duvekot, H A Bremer, T H M Hasaart, F M C Delemarre, K W M Bloemenkamp, C A van Meir, C Willekes, E J Wijnen, M Rijken, S le Cessie, F J M E Roumen, J G Thornton, J M M van Lith, B W J Mol, S A Scherjon, DIGITAT study group, P J A van der Lans, G Kleiverda, M H B Heres, M Wouters, A J M Huisjes, M J Noordam, D N M Papastonis, R J P Rijnders, W J van Wijngaarden, M E van Huizen, C J de Groot, R H Stigter, B M C Akerboom, J M Burggraaff, A J van Loon, P J M Pernet, A Lub, J G Santema, F J A Copraij, L S M Ribbert, J M J Sporken, J W de Leeuw, P E van der Moer, N van Gemund, R Aardenburg, C M van Oirschot, A P Drogtrop, J P R Doornbos, A A van Ginkel, J van Eyck, K E Boers, S M C Vijgen, D Bijlenga, J A M van der Post, D J Bekedam, A Kwee, P C M van der Salm, M G van Pampus, M E A Spaanderman, K de Boer, J J Duvekot, H A Bremer, T H M Hasaart, F M C Delemarre, K W M Bloemenkamp, C A van Meir, C Willekes, E J Wijnen, M Rijken, S le Cessie, F J M E Roumen, J G Thornton, J M M van Lith, B W J Mol, S A Scherjon, DIGITAT study group, P J A van der Lans, G Kleiverda, M H B Heres, M Wouters, A J M Huisjes, M J Noordam, D N M Papastonis, R J P Rijnders, W J van Wijngaarden, M E van Huizen, C J de Groot, R H Stigter, B M C Akerboom, J M Burggraaff, A J van Loon, P J M Pernet, A Lub, J G Santema, F J A Copraij, L S M Ribbert, J M J Sporken, J W de Leeuw, P E van der Moer, N van Gemund, R Aardenburg, C M van Oirschot, A P Drogtrop, J P R Doornbos, A A van Ginkel, J van Eyck

Abstract

Objective: To compare the effect of induction of labour with a policy of expectant monitoring for intrauterine growth restriction near term.

Design: Multicentre randomised equivalence trial (the Disproportionate Intrauterine Growth Intervention Trial At Term (DIGITAT)).

Setting: Eight academic and 44 non-academic hospitals in the Netherlands between November 2004 and November 2008.

Participants: Pregnant women who had a singleton pregnancy beyond 36+0 weeks' gestation with suspected intrauterine growth restriction.

Interventions: Induction of labour or expectant monitoring.

Main outcome measures: The primary outcome was a composite measure of adverse neonatal outcome, defined as death before hospital discharge, five minute Apgar score of less than 7, umbilical artery pH of less than 7.05, or admission to the intensive care unit. Operative delivery (vaginal instrumental delivery or caesarean section) was a secondary outcome. Analysis was by intention to treat, with confidence intervals calculated for the differences in percentages or means.

Results: 321 pregnant women were randomly allocated to induction and 329 to expectant monitoring. Induction group infants were delivered 10 days earlier (mean difference -9.9 days, 95% CI -11.3 to -8.6) and weighed 130 g less (mean difference -130 g, 95% CI -188 g to -71 g) than babies in the expectant monitoring group. A total of 17 (5.3%) infants in the induction group experienced the composite adverse neonatal outcome, compared with 20 (6.1%) in the expectant monitoring group (difference -0.8%, 95% CI -4.3% to 3.2%). Caesarean sections were performed on 45 (14.0%) mothers in the induction group and 45 (13.7%) in the expectant monitoring group (difference 0.3%, 95% CI -5.0% to 5.6%).

Conclusions: In women with suspected intrauterine growth restriction at term, we found no important differences in adverse outcomes between induction of labour and expectant monitoring. Patients who are keen on non-intervention can safely choose expectant management with intensive maternal and fetal monitoring; however, it is rational to choose induction to prevent possible neonatal morbidity and stillbirth.

Trial registration: International Standard Randomised Controlled Trial number ISRCTN10363217.

Conflict of interest statement

Conflicts of interest: All authors have completed the Unified Competing Interest form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: they had support from ZonMw, the Netherlands Organisation for Health Research and Development, for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; and no other relationships or activities that could appear to have influenced the submitted work.

Figures

https://www.ncbi.nlm.nih.gov/pmc/articles/instance/4787673/bin/boek800631.f1_default.jpg
Flow diagram of the trial process

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Source: PubMed

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