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) orexpectant 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.
RCT Entities:
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: Candace Tannis; Rachel Fletcher-Slater; Inessa Lopez; Alexandrah Gichingiri; Mario Cassara; Susanne Lachapelle; Elizabeth Garland Journal: Int Public Health J Date: 2018-10-01
Authors: Jennifer L Bailit; William Grobman; Yuan Zhao; Ronald J Wapner; Uma M Reddy; Michael W Varner; Kenneth J Leveno; Steve N Caritis; Jay D Iams; Alan T Tita; George Saade; Yoram Sorokin; Dwight J Rouse; Sean C Blackwell; Jorge E Tolosa; J Peter VanDorsten Journal: Am J Obstet Gynecol Date: 2014-06-28 Impact factor: 8.661
Authors: H Lehnen; N Mosblech; T Reineke; A Puchooa; I Menke-Möllers; U Zechner; U Gembruch Journal: Geburtshilfe Frauenheilkd Date: 2013-05 Impact factor: 2.915
Authors: H Stepan; S Kuse-Föhl; W Klockenbusch; W Rath; B Schauf; T Walther; D Schlembach Journal: Geburtshilfe Frauenheilkd Date: 2015-09 Impact factor: 2.915
Authors: Wietske Hermes; Arie Franx; Maria G van Pampus; Kitty W Bloemenkamp; Joris A van der Post; Martina Porath; Gabrielle Ponjee; Jouke T Tamsma; Ben W Mol; Christianne J de Groot Journal: BMC Pregnancy Childbirth Date: 2010-06-01 Impact factor: 3.007