Induction of labour versus expectant monitoring for gestational hypertension or mild pre-eclampsia after 36 weeks' gestation (HYPITAT)
Autor: | Christianne J.M. de Groot, Dick J. Bekedam, Arie Franx, Jan G. Aarnoudse, Karin de Boer, Anjoke J.M. Huisjes, Aren J. van Loon, Corine M. Koopmans, D.N. Papatsonis, Anneke Kwee, A.P. Drogtrop, Paul P. van den Berg, Frans J.M.E. Roumen, Hubertina C.J. Scheepers, Henk Groen, Maria G. van Pampus, Christine Willekes, Kitty W.M. Bloemenkamp, Ben W.J. Mol, Jan M. Burggraaff, Joris A. M. van der Post, S.M. Vijgen, A. Lub, Denise Bijlenga |
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Přispěvatelé: | Other departments, ARD - Amsterdam Reproduction and Development, Obstetrics and Gynaecology, APH - Amsterdam Public Health, Science in Healthy Ageing & healthcaRE (SHARE), Reproductive Origins of Adult Health and Disease (ROAHD) |
Jazyk: | angličtina |
Rok vydání: | 2009 |
Předmět: |
Adult
Gestational hypertension HELLP Syndrome medicine.medical_specialty HELLP syndrome NETHERLANDS POSTPARTUM HEMORRHAGE Gestational Age Pulmonary Edema DIAGNOSIS Severity of Illness Index Statistics Nonparametric Preeclampsia Pre-Eclampsia Thromboembolism medicine MANAGEMENT Humans Childbirth Labor Induced Fetal Monitoring Abruptio Placentae reproductive and urinary physiology Pregnancy Eclampsia Placental abruption business.industry Obstetrics Patient Selection Pregnancy Outcome Gestational age MATCHED COHORT WOMEN Hypertension Pregnancy-Induced General Medicine medicine.disease Logistic Models Maternal Mortality PREGNANCY ELECTIVE INDUCTION RISK-FACTORS ECLAMPSIA Female business |
Zdroj: | Lancet, 374(9694), 979-988. Elsevier Limited LANCET, 374(9694), 979-988. ELSEVIER SCIENCE INC |
ISSN: | 1474-547X 0140-6736 |
DOI: | 10.1016/s0140-6736(09)60736-4 |
Popis: | 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 |
Databáze: | OpenAIRE |
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