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.

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;
Related Documents :	9241028 - Pregnancy in endurance athletes. 12380868 - Pregnancy outcome in the elderly gravida in addis ababa. 15321158 - Parturition and angioneurotic oedema. 8761968 - Prostaglandin h synthase-2 in human gestational tissues: regulation in amnion. 6684288 - Examination of rat placental lactogen and prolactin at 6-hr intervals during midpregnancy. 19900048 - Should apparently uncomplicated monochorionic twins be delivered electively at 32 weeks?
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
Export Citation:	APA/MLA Format Download EndNote Download BibTex
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

Previous Document: Brief report: The KIDSCREEN follow-up study on Health-related Quality of Life (HRQoL) in Spanish chi...
Next Document: The use of PEGylated liposomes to prolong circulation lifetimes of tissue plasminogen activator.