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

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 n...

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Autores principales: Boers, K E, Vijgen, S M C, Bijlenga, D, van der Post, J A M, Bekedam, D J, Kwee, A, van der Salm, P C M, van Pampus, M G, Spaanderman, M E A, de Boer, K, Duvekot, J J, Bremer, H A, Hasaart, T H M, Delemarre, F M C, Bloemenkamp, K W M, van Meir, C A, Willekes, C, Wijnen, E J, Rijken, M, le Cessie, S, Roumen, F J M E, Thornton, J G, van Lith, J M M, Mol, B W J, Scherjon, S A
Formato: Texto
Lenguaje:English
Publicado: BMJ Publishing Group Ltd. 2010
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3005565/
https://www.ncbi.nlm.nih.gov/pubmed/21177352
http://dx.doi.org/10.1136/bmj.c7087
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author Boers, K E
Vijgen, S M C
Bijlenga, D
van der Post, J A M
Bekedam, D J
Kwee, A
van der Salm, P C M
van Pampus, M G
Spaanderman, M E A
de Boer, K
Duvekot, J J
Bremer, H A
Hasaart, T H M
Delemarre, F M C
Bloemenkamp, K W M
van Meir, C A
Willekes, C
Wijnen, E J
Rijken, M
le Cessie, S
Roumen, F J M E
Thornton, J G
van Lith, J M M
Mol, B W J
Scherjon, S A
author_facet Boers, K E
Vijgen, S M C
Bijlenga, D
van der Post, J A M
Bekedam, D J
Kwee, A
van der Salm, P C M
van Pampus, M G
Spaanderman, M E A
de Boer, K
Duvekot, J J
Bremer, H A
Hasaart, T H M
Delemarre, F M C
Bloemenkamp, K W M
van Meir, C A
Willekes, C
Wijnen, E J
Rijken, M
le Cessie, S
Roumen, F J M E
Thornton, J G
van Lith, J M M
Mol, B W J
Scherjon, S A
author_sort Boers, K E
collection PubMed
description 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.
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spelling pubmed-30055652011-01-03 Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT) Boers, K E Vijgen, S M C Bijlenga, D van der Post, J A M Bekedam, D J Kwee, A van der Salm, P C M van Pampus, M G Spaanderman, M E A de Boer, K Duvekot, J J Bremer, H A Hasaart, T H M Delemarre, F M C Bloemenkamp, K W M van Meir, C A Willekes, C Wijnen, E J Rijken, M le Cessie, S Roumen, F J M E Thornton, J G van Lith, J M M Mol, B W J Scherjon, S A BMJ Research 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. BMJ Publishing Group Ltd. 2010-12-21 /pmc/articles/PMC3005565/ /pubmed/21177352 http://dx.doi.org/10.1136/bmj.c7087 Text en © Boers et al 2010 This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.
spellingShingle Research
Boers, K E
Vijgen, S M C
Bijlenga, D
van der Post, J A M
Bekedam, D J
Kwee, A
van der Salm, P C M
van Pampus, M G
Spaanderman, M E A
de Boer, K
Duvekot, J J
Bremer, H A
Hasaart, T H M
Delemarre, F M C
Bloemenkamp, K W M
van Meir, C A
Willekes, C
Wijnen, E J
Rijken, M
le Cessie, S
Roumen, F J M E
Thornton, J G
van Lith, J M M
Mol, B W J
Scherjon, S A
Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT)
title Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT)
title_full Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT)
title_fullStr Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT)
title_full_unstemmed Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT)
title_short Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT)
title_sort induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (digitat)
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3005565/
https://www.ncbi.nlm.nih.gov/pubmed/21177352
http://dx.doi.org/10.1136/bmj.c7087
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