title: Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT).
abstract: OBJECTIVE
  To compare the effect of induction of labour with a policy of expectant monitoring for intrauterine growth restriction near term.
  
  
  METHODS
  Multicentre randomised equivalence trial (the Disproportionate Intrauterine Growth Intervention Trial At Term (DIGITAT)).
  
  
  METHODS
  Eight academic and 44 non-academic hospitals in the Netherlands between November 2004 and November 2008.
  
  
  METHODS
  Pregnant women who had a singleton pregnancy beyond 36+0 weeks' gestation with suspected intrauterine growth restriction.
  
  
  METHODS
  Induction of labour or expectant monitoring.
  
  
  METHODS
  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.
  
  
  BACKGROUND
  International Standard Randomised Controlled Trial number ISRCTN10363217.
authors.affiliation: Leiden University Medical Centre, Leiden, Netherlands. k.e.boers@lumc.nl
authors.forename: K E
authors.initials: KE
authors.lastname: Boers
authors.forename: S M C
authors.initials: SM
authors.lastname: Vijgen
authors.forename: D
authors.initials: D
authors.lastname: Bijlenga
authors.forename: J A M
authors.initials: JA
authors.lastname: van der Post
authors.forename: D J
authors.initials: DJ
authors.lastname: Bekedam
authors.forename: A
authors.initials: A
authors.lastname: Kwee
authors.forename: P C M
authors.initials: PC
authors.lastname: van der Salm
authors.forename: M G
authors.initials: MG
authors.lastname: van Pampus
authors.forename: M E A
authors.initials: ME
authors.lastname: Spaanderman
authors.forename: K
authors.initials: K
authors.lastname: de Boer
authors.forename: J J
authors.initials: JJ
authors.lastname: Duvekot
authors.forename: H A
authors.initials: HA
authors.lastname: Bremer
authors.forename: T H M
authors.initials: TH
authors.lastname: Hasaart
authors.forename: F M C
authors.initials: FM
authors.lastname: Delemarre
authors.forename: K W M
authors.initials: KW
authors.lastname: Bloemenkamp
authors.forename: C A
authors.initials: CA
authors.lastname: van Meir
authors.forename: C
authors.initials: C
authors.lastname: Willekes
authors.forename: E J
authors.initials: EJ
authors.lastname: Wijnen
authors.forename: M
authors.initials: M
authors.lastname: Rijken
authors.forename: S
authors.initials: S
authors.lastname: le Cessie
authors.forename: F J M E
authors.initials: FJ
authors.lastname: Roumen
authors.forename: J G
authors.initials: JG
authors.lastname: Thornton
authors.forename: J M M
authors.initials: JM
authors.lastname: van Lith
authors.forename: B W J
authors.initials: BW
authors.lastname: Mol
authors.forename: S A
authors.initials: SA
authors.lastname: Scherjon
mesh_terms: D000328:Adult; D005260:Female; D005317:Fetal Growth Retardation / Q000628:therapy*; D005865:Gestational Age; D006801:Humans; D007745:Labor Onset; D007751:Labor, Induced; D007902:Length of Stay; D011247:Pregnancy; D011256:Pregnancy Outcome; D057832:Watchful Waiting; D055815:Young Adult