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

Corine M. Koopmans*, Denise Bijlenga, Henk Groen, Sylvia MC Vijgen, Jan G. Aarnoudse, Dick J. Bekedam, Paul P. van den Berg, Karin de Boer, Jan M. Burggraaff, Kitty WM Bloemenkamp, Addy P. Drogtrop, Arie Franx, Christianne JM de Groot, Anjoke JM Huisjes, Anneke Kwee, Aren J. van Loon, Annemiek Lub, Dimitri NM Papatsonis, Joris AM van der Post, Frans JME RoumenHubertina CJ Scheepers, Christine Willekes, Ben WJ Mol, Maria G. van Pampus

*Corresponding author for this work

Research output: Contribution to journalArticle

429 Citations (Scopus)

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. Funding: ZonMw.

Original languageEnglish
Pages (from-to)979-988
Number of pages10
JournalThe Lancet
Volume374
Issue number9694
DOIs
Publication statusPublished - 25 Sep 2009

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    Koopmans, C. M., Bijlenga, D., Groen, H., Vijgen, S. MC., Aarnoudse, J. G., Bekedam, D. J., van den Berg, P. P., de Boer, K., Burggraaff, J. M., Bloemenkamp, K. WM., Drogtrop, A. P., Franx, A., de Groot, C. JM., Huisjes, A. JM., Kwee, A., van Loon, A. J., Lub, A., Papatsonis, D. NM., van der Post, J. AM., ... van Pampus, M. G. (2009). 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. The Lancet, 374(9694), 979-988. https://doi.org/10.1016/S0140-6736(09)60736-4