Journal Article

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

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

2009

Overview

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. 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. 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. Induction of labour is associated with improved maternal outcome and should be advised for women with mild hypertensive disease beyond 37 weeks' gestation. ZonMw.

• Publisher: Elsevier Ltd,Elsevier,Elsevier Limited
• Subject: Abruptio Placentae - epidemiology / Adult / Arterial hypertension. Arterial hypotension / Biological and medical sciences / Blood and lymphatic vessels / Blood pressure / Cardiology. Vascular system / Childbirth & labor / Clinical trials / Diabetes / Disease control / Diseases of mother, fetus and pregnancy / Eclampsia - epidemiology / Edema / Enzymes / Evidence-based medicine / Female / Fetal Monitoring - methods / Fetuses / General aspects / Gestation / Gestational Age / Gynecology. Andrology. Obstetrics / Health risk assessment / Heart / HELLP Syndrome - epidemiology / Hemorrhage / Humans / Hypertension / Hypertension, Pregnancy-Induced - epidemiology / Hypertension, Pregnancy-Induced - therapy / Induced labor / Intensive care / Internal Medicine / Labor, Induced - methods / Logistic Models / Lung diseases / Masking / Maternal Mortality / Medical records / Medical research / Medical sciences / Monitoring / Morbidity / Mortality / Motivation / Neonates / Netherlands - epidemiology / Obstetrics / Patient Selection / Patients / Placenta / Postpartum Hemorrhage - epidemiology / Pre-eclampsia / Pre-Eclampsia - epidemiology / Pre-Eclampsia - therapy / Preeclampsia / Pregnancy / Pregnancy Outcome - epidemiology / Pregnancy. Fetus. Placenta / Proteins / Proteinuria / Pulmonary Edema - epidemiology / Randomization / Robust control / Severity of Illness Index / Statistics, Nonparametric / Thromboembolism / Thromboembolism - epidemiology / Urine / Womens health