Document Detail


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.
MedLine Citation:
PMID:  19656558     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Corine M Koopmans; Denise Bijlenga; Henk Groen; Sylvia M C Vijgen; Jan G Aarnoudse; Dick J Bekedam; Paul P van den Berg; Karin de Boer; Jan M Burggraaff; Kitty W M Bloemenkamp; Addy P Drogtrop; Arie Franx; Christianne J M de Groot; Anjoke J M Huisjes; Anneke Kwee; Aren J van Loon; Annemiek Lub; Dimitri N M Papatsonis; Joris A M van der Post; Frans J M E Roumen; Hubertina C J Scheepers; Christine Willekes; Ben W J Mol; Maria G van Pampus;
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2009-08-03
Journal Detail:
Title:  Lancet     Volume:  374     ISSN:  1474-547X     ISO Abbreviation:  Lancet     Publication Date:  2009 Sep 
Date Detail:
Created Date:  2009-09-21     Completed Date:  2009-10-02     Revised Date:  2010-03-05    
Medline Journal Info:
Nlm Unique ID:  2985213R     Medline TA:  Lancet     Country:  England    
Other Details:
Languages:  eng     Pagination:  979-88     Citation Subset:  AIM; IM    
Affiliation:
Department of Obstetrics and Gynaecology, University Medical Centre, Groningen, Netherlands. c.m.koopmans@og.umcg.nl
Data Bank Information
Bank Name/Acc. No.:
ISRCTN/ISRCTN08132825
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MeSH Terms
Descriptor/Qualifier:
Abruptio Placentae / epidemiology
Adult
Eclampsia / epidemiology
Female
Fetal Monitoring / methods*
Gestational Age
HELLP Syndrome / epidemiology
Humans
Hypertension, Pregnancy-Induced / epidemiology,  therapy*
Labor, Induced / methods*
Logistic Models
Maternal Mortality
Netherlands / epidemiology
Patient Selection
Postpartum Hemorrhage / epidemiology
Pre-Eclampsia / epidemiology,  therapy*
Pregnancy
Pregnancy Outcome / epidemiology
Pulmonary Edema / epidemiology
Severity of Illness Index
Statistics, Nonparametric
Thromboembolism / epidemiology
Investigator
Investigator/Affiliation:
P J A van der Lans / ; G Kleiverda / ; M H B Heres / ; P C M van der Salm / ; R J P Rijnders / ; W J van Wijngaarden / ; M E van Huizen / ; R H Stigter / ; B M C Akerboom / ; T H M Hasaart / ; C A van Meir / ; P J M Pernet / ; M J C P Hanssen / ; J G Santema / ; F J A Copraij / ; E van Beek / ; J M J Sporken / ; R Aardenburg / ; E J Wijnen / ; J P R Doornbos /
Comments/Corrections
Comment In:
Evid Based Med. 2010 Feb;15(1):11-2   [PMID:  20176870 ]
Lancet. 2010 Jan 9;375(9709):119; author reply 119-20   [PMID:  20109885 ]
Lancet. 2009 Sep 19;374(9694):951-2   [PMID:  19656557 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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