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|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|
van den Berg, P.
de Boer, K.
de Groot, C.
van Loon, A.
van der Post, J.
|Citation:||Lancet, 2009; 374(9694):979-988|
|Corine M Koopmans ... Ben WJ Mol ... et al. for the HYPITAT study group|
|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. 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.|
|Keywords:||HYPITAT study group; Humans; Pulmonary Edema; Hypertension, Pregnancy-Induced; Eclampsia; HELLP Syndrome; Pre-Eclampsia; Abruptio Placentae; Postpartum Hemorrhage; Thromboembolism; Fetal Monitoring; Pregnancy Outcome; Labor, Induced; Severity of Illness Index; Maternal Mortality; Logistic Models; Statistics, Nonparametric; Gestational Age; Pregnancy; Patient Selection; Adult; Netherlands; Female|
|Rights:||Copyright © 2009 Elsevier Ltd. All rights reserved.|
|Appears in Collections:||Paediatrics publications|
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