title: Induction of labour versus expectant monitoring for gestational hypertension or mild pre-eclampsia after 36 weeks' gestation (HYPITAT): a multicentre, open-label randomised controlled trial.
abstract: BACKGROUND
  Robust evidence to direct management of pregnant women with mild hypertensive disease at term is scarce. We investigated whether induction of labour in women with a singleton pregnancy complicated by gestational hypertension or mild pre-eclampsia reduces severe maternal morbidity.
  
  
  METHODS
  We undertook a multicentre, parallel, open-label randomised controlled trial in six academic and 32 non-academic hospitals in the Netherlands between October, 2005, and March, 2008. We enrolled patients with a singleton pregnancy at 36-41 weeks' gestation, and who had gestational hypertension or mild pre-eclampsia. Participants were randomly allocated in a 1:1 ratio by block randomisation with a web-based application system to receive either induction of labour or expectant monitoring. Masking of intervention allocation was not possible. The primary outcome was a composite measure of poor maternal outcome--maternal mortality, maternal morbidity (eclampsia, HELLP syndrome, pulmonary oedema, thromboembolic disease, and placental abruption), progression to severe hypertension or proteinuria, and major post-partum haemorrhage (>1000 mL blood loss). Analysis was by intention to treat and treatment effect is presented as relative risk. This study is registered, number ISRCTN08132825.
  
  
  RESULTS
  756 patients were allocated to receive induction of labour (n=377 patients) or expectant monitoring (n=379). 397 patients refused randomisation but authorised use of their medical records. Of women who were randomised, 117 (31%) allocated to induction of labour developed poor maternal outcome compared with 166 (44%) allocated to expectant monitoring (relative risk 0.71, 95% CI 0.59-0.86, p<0.0001). No cases of maternal or neonatal death or eclampsia were recorded.
  
  
  CONCLUSIONS
  Induction of labour is associated with improved maternal outcome and should be advised for women with mild hypertensive disease beyond 37 weeks' gestation.
  
  
  BACKGROUND
  ZonMw.
authors: University Medical Centre, Groningen, Netherlands. Electronic address: c.m.koopmans@og.umcg.nl.
authors: Corine M
authors: CM
authors: Koopmans
authors: Academic Medical Centre, Amsterdam, Netherlands.
authors: Denise
authors: D
authors: Bijlenga
authors: University Medical Centre, Groningen, Netherlands.
authors: Henk
authors: H
authors: Groen
authors: Academic Medical Centre, Amsterdam, Netherlands.
authors: Sylvia Mc
authors: SM
authors: Vijgen
authors: University Medical Centre, Groningen, Netherlands.
authors: Jan G
authors: JG
authors: Aarnoudse
authors: Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands.
authors: Dick J
authors: DJ
authors: Bekedam
authors: University Medical Centre, Groningen, Netherlands.
authors: Paul P
authors: PP
authors: van den Berg
authors: Hospital Rijnstate, Arnhem, Netherlands.
authors: Karin
authors: K
authors: de Boer
authors: Scheper Hospital, Emmen, Netherlands.
authors: Jan M
authors: JM
authors: Burggraaff
authors: Leiden University Medical Centre, Netherlands.
authors: Kitty Wm
authors: KW
authors: Bloemenkamp
authors: Twee Steden Hospital, Tilburg, Netherlands.
authors: Addy P
authors: AP
authors: Drogtrop
authors: Sint Elisabeth Hospital, Tilburg, Netherlands.
authors: Arie
authors: A
authors: Franx
authors: Medical Centre Haaglanden, Den Haag, Netherlands.
authors: Christianne Jm
authors: CJ
authors: de Groot
authors: Gelre Hospital, Apeldoorn, Netherlands.
authors: Anjoke Jm
authors: AJ
authors: Huisjes
authors: University Medical Centre, Utrecht, Netherlands.
authors: Anneke
authors: A
authors: Kwee
authors: Martini Hospital, Groningen, Netherlands.
authors: Aren J
authors: AJ
authors: van Loon
authors: Spaarne Hospital, Hoofddorp, Netherlands.
authors: Annemiek
authors: A
authors: Lub
authors: Amphia Hospital, Breda, Netherlands.
authors: Dimitri Nm
authors: DN
authors: Papatsonis
authors: Academic Medical Centre, Amsterdam, Netherlands.
authors: Joris Am
authors: JA
authors: van der Post
authors: Atrium Medical Centre, Heerlen, Netherlands.
authors: Frans Jme
authors: FJ
authors: Roumen
authors: University Medical Centre St Radboud, Nijmegen, Netherlands.
authors: Hubertina Cj
authors: HC
authors: Scheepers
authors: University Hospital Maastricht, Netherlands.
authors: Christine
authors: C
authors: Willekes
authors: Academic Medical Centre, Amsterdam, Netherlands; Maxima Medical Centre, Veldhoven, Netherlands.
authors: Ben Wj
authors: BW
authors: Mol
authors: University Medical Centre, Groningen, Netherlands.
authors: Maria G
authors: MG
authors: van Pampus
mesh_terms: D000037:Abruptio Placentae / Q000453:epidemiology; D000328:Adult; D004461:Eclampsia / Q000453:epidemiology; D005260:Female; D005323:Fetal Monitoring / Q000379:methods*; D005865:Gestational Age; D017359:HELLP Syndrome / Q000453:epidemiology; D006801:Humans; D046110:Hypertension, Pregnancy-Induced / Q000453:epidemiology / Q000628:therapy*; D007751:Labor, Induced / Q000379:methods*; D016015:Logistic Models; D008428:Maternal Mortality; D009426:Netherlands / Q000453:epidemiology; D018579:Patient Selection; D006473:Postpartum Hemorrhage / Q000453:epidemiology; D011225:Pre-Eclampsia / Q000453:epidemiology / Q000628:therapy*; D011247:Pregnancy; D011256:Pregnancy Outcome / Q000453:epidemiology; D011654:Pulmonary Edema / Q000453:epidemiology; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D013923:Thromboembolism / Q000453:epidemiology