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.

Autor:	Koopmans CM; University Medical Centre, Groningen, Netherlands. Electronic address: c.m.koopmans@og.umcg.nl., Bijlenga D; Academic Medical Centre, Amsterdam, Netherlands., Groen H; University Medical Centre, Groningen, Netherlands., Vijgen SM; Academic Medical Centre, Amsterdam, Netherlands., Aarnoudse JG; University Medical Centre, Groningen, Netherlands., Bekedam DJ; Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands., van den Berg PP; University Medical Centre, Groningen, Netherlands., de Boer K; Hospital Rijnstate, Arnhem, Netherlands., Burggraaff JM; Scheper Hospital, Emmen, Netherlands., Bloemenkamp KW; Leiden University Medical Centre, Netherlands., Drogtrop AP; Twee Steden Hospital, Tilburg, Netherlands., Franx A; Sint Elisabeth Hospital, Tilburg, Netherlands., de Groot CJ; Medical Centre Haaglanden, Den Haag, Netherlands., Huisjes AJ; Gelre Hospital, Apeldoorn, Netherlands., Kwee A; University Medical Centre, Utrecht, Netherlands., van Loon AJ; Martini Hospital, Groningen, Netherlands., Lub A; Spaarne Hospital, Hoofddorp, Netherlands., Papatsonis DN; Amphia Hospital, Breda, Netherlands., van der Post JA; Academic Medical Centre, Amsterdam, Netherlands., Roumen FJ; Atrium Medical Centre, Heerlen, Netherlands., Scheepers HC; University Medical Centre St Radboud, Nijmegen, Netherlands., Willekes C; University Hospital Maastricht, Netherlands., Mol BW; Academic Medical Centre, Amsterdam, Netherlands; Maxima Medical Centre, Veldhoven, Netherlands., van Pampus MG; University Medical Centre, Groningen, Netherlands.
Jazyk:	angličtina
Zdroj:	Lancet (London, England) [Lancet] 2009 Sep 19; Vol. 374 (9694), pp. 979-988. Date of Electronic Publication: 2009 Aug 03.
DOI:	10.1016/S0140-6736(09)60736-4
Abstrakt:	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. Findings: 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. Interpretation: Induction of labour is associated with improved maternal outcome and should be advised for women with mild hypertensive disease beyond 37 weeks' gestation. Funding: ZonMw.
Databáze:	MEDLINE
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