TY - JOUR
T1 - Induction of labour versus expectant monitoring for gestational hypertension or mild pre-eclampsia after 36 weeks' gestation (HYPITAT)
T2 - a multicentre, open-label randomised controlled trial
AU - Koopmans, Corine M.
AU - Bijlenga, Denise
AU - Groen, Henk
AU - Vijgen, Sylvia MC
AU - Aarnoudse, Jan G.
AU - Bekedam, Dick J.
AU - van den Berg, Paul P.
AU - de Boer, Karin
AU - Burggraaff, Jan M.
AU - Bloemenkamp, Kitty WM
AU - Drogtrop, Addy P.
AU - Franx, Arie
AU - de Groot, Christianne JM
AU - Huisjes, Anjoke JM
AU - Kwee, Anneke
AU - van Loon, Aren J.
AU - Lub, Annemiek
AU - Papatsonis, Dimitri NM
AU - van der Post, Joris AM
AU - Roumen, Frans JME
AU - Scheepers, Hubertina CJ
AU - Willekes, Christine
AU - Mol, Ben WJ
AU - van Pampus, Maria G.
PY - 2009/9/25
Y1 - 2009/9/25
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=70349398300&partnerID=8YFLogxK
U2 - 10.1016/S0140-6736(09)60736-4
DO - 10.1016/S0140-6736(09)60736-4
M3 - Article
C2 - 19656558
AN - SCOPUS:70349398300
SN - 0140-6736
VL - 374
SP - 979
EP - 988
JO - The Lancet
JF - The Lancet
IS - 9694
ER -