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BMC Pregnancy and Childbirth
Published in: BMC Pregnancy and Childbirth 1/2007

Open Access 01-12-2007 | Study protocol

Disproportionate Intrauterine Growth Intervention Trial At Term: DIGITAT

Authors: Kim E Boers, Denise Bijlenga, Ben WJ Mol, Saskia LeCessie, Erwin Birnie, Marielle G van Pampus, Rob H Stigter, Kitty WM Bloemenkamp, Claudia A van Meir, Joris AM van der Post, Dick J Bekedam, Lucy SM Ribbert, Addie P Drogtrop, Paulien CM van der Salm, Anjoke JM Huisjes, Christine Willekes, Frans JME Roumen, Hubertina CJ Scheepers, Karin de Boer, Johannes J Duvekot, Jim G Thornton, Sicco A Scherjon

Published in: BMC Pregnancy and Childbirth | Issue 1/2007

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Abstract

Background

Around 80% of intrauterine growth restricted (IUGR) infants are born at term. They have an increase in perinatal mortality and morbidity including behavioral problems, minor developmental delay and spastic cerebral palsy. Management is controversial, in particular the decision whether to induce labour or await spontaneous delivery with strict fetal and maternal surveillance. We propose a randomised trial to compare effectiveness, costs and maternal quality of life for induction of labour versus expectant management in women with a suspected IUGR fetus at term.

Methods/design

The proposed trial is a multi-centre randomised study in pregnant women who are suspected on clinical grounds of having an IUGR child at a gestational age between 36+0 and 41+0 weeks. After informed consent women will be randomly allocated to either induction of labour or expectant management with maternal and fetal monitoring. Randomisation will be web-based. The primary outcome measure will be a composite neonatal morbidity and mortality. Secondary outcomes will be severe maternal morbidity, maternal quality of life and costs. Moreover, we aim to assess neurodevelopmental and neurobehavioral outcome at two years as assessed by a postal enquiry (Child Behavioral Check List-CBCL and Ages and Stages Questionnaire-ASQ). Analysis will be by intention to treat. Quality of life analysis and a preference study will also be performed in the same study population. Health technology assessment with an economic analysis is part of this so called Digitat trial (Disproportionate Intrauterine Growth Intervention Trial At Term). The study aims to include 325 patients per arm.

Discussion

This trial will provide evidence for which strategy is superior in terms of neonatal and maternal morbidity and mortality, costs and maternal quality of life aspects. This will be the first randomised trial for IUGR at term.

Trial registration

Dutch Trial Register and ISRCTN-Register: ISRCTN10363217.
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Metadata
Title
Disproportionate Intrauterine Growth Intervention Trial At Term: DIGITAT
Authors
Kim E Boers
Denise Bijlenga
Ben WJ Mol
Saskia LeCessie
Erwin Birnie
Marielle G van Pampus
Rob H Stigter
Kitty WM Bloemenkamp
Claudia A van Meir
Joris AM van der Post
Dick J Bekedam
Lucy SM Ribbert
Addie P Drogtrop
Paulien CM van der Salm
Anjoke JM Huisjes
Christine Willekes
Frans JME Roumen
Hubertina CJ Scheepers
Karin de Boer
Johannes J Duvekot
Jim G Thornton
Sicco A Scherjon
Publication date
01-12-2007
Publisher
BioMed Central
Published in
BMC Pregnancy and Childbirth / Issue 1/2007
Electronic ISSN: 1471-2393
DOI
https://doi.org/10.1186/1471-2393-7-12

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