title: Disproportionate Intrauterine Growth Intervention Trial At Term: DIGITAT.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Dutch Trial Register and ISRCTN-Register: ISRCTN10363217.
authors.affiliation: Department of Obstetrics and Gynaecology, Leiden University Medical Center, The Netherlands. k.e.boers@lumc.nl
authors.forename: Kim E
authors.initials: KE
authors.lastname: Boers
authors.forename: Denise
authors.initials: D
authors.lastname: Bijlenga
authors.forename: Ben W J
authors.initials: BW
authors.lastname: Mol
authors.forename: Saskia
authors.initials: S
authors.lastname: LeCessie
authors.forename: Erwin
authors.initials: E
authors.lastname: Birnie
authors.forename: Marielle G
authors.initials: MG
authors.lastname: van Pampus
authors.forename: Rob H
authors.initials: RH
authors.lastname: Stigter
authors.forename: Kitty W M
authors.initials: KW
authors.lastname: Bloemenkamp
authors.forename: Claudia A
authors.initials: CA
authors.lastname: van Meir
authors.forename: Joris A M
authors.initials: JA
authors.lastname: van der Post
authors.forename: Dick J
authors.initials: DJ
authors.lastname: Bekedam
authors.forename: Lucy S M
authors.initials: LS
authors.lastname: Ribbert
authors.forename: Addie P
authors.initials: AP
authors.lastname: Drogtrop
authors.forename: Paulien C M
authors.initials: PC
authors.lastname: van der Salm
authors.forename: Anjoke J M
authors.initials: AJ
authors.lastname: Huisjes
authors.forename: Christine
authors.initials: C
authors.lastname: Willekes
authors.forename: Frans J M E
authors.initials: FJ
authors.lastname: Roumen
authors.forename: Hubertina C J
authors.initials: HC
authors.lastname: Scheepers
authors.forename: Karin
authors.initials: K
authors.lastname: de Boer
authors.forename: Johannes J
authors.initials: JJ
authors.lastname: Duvekot
authors.forename: Jim G
authors.initials: JG
authors.lastname: Thornton
authors.forename: Sicco A
authors.initials: SA
authors.lastname: Scherjon
mesh_terms: D000328:Adult; D016001:Confidence Intervals; D003365:Costs and Cost Analysis; D005260:Female; D005317:Fetal Growth Retardation / Q000191:economics* / Q000453:epidemiology; D006801:Humans; D007229:Infant Welfare / Q000191:economics* / Q000706:statistics & numerical data; D007231:Infant, Newborn; D007751:Labor, Induced / Q000191:economics* / Q000379:methods; D008429:Maternal Welfare / Q000191:economics* / Q000706:statistics & numerical data; D011247:Pregnancy; D011256:Pregnancy Outcome / Q000191:economics* / Q000453:epidemiology; D011446:Prospective Studies; D011788:Quality of Life; D047929:Term Birth