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
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DOI：
10.1016/s0140-6736(09)60736-4
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发表时间：
2009-09-19
期刊：
影响因子：
168.9
通讯作者：
van Pampus, Maria G.
中科院分区：
文献类型：
--
作者：
Koopmans, Corine M.;Bijlenga, Denise;van Pampus, Maria G.
背景：直接治疗轻度妊娠期高血压疾病的有力证据很少。我们调查是否引产的妇女与单胎妊娠并发妊娠期高血压或轻度先兆子痫降低严重的孕产妇发病率。方法我们进行了多中心，平行，开放标签的随机对照试验，在6个学术和32个非学术医院在荷兰之间的2005年10月，2008年3月。我们招募了妊娠36-41周的单胎妊娠患者，这些患者患有妊娠期高血压或轻度先兆子痫。受试者通过区组随机化以1：1的比例随机分配。通过一个基于网络的应用系统接收引产或预产期监测。干预分配的掩蔽是不可能的。主要结局是一个综合指标，包括不良的孕产妇结局-孕产妇死亡率、孕产妇发病率（子痫、HELLP综合征、肺水肿、血栓栓塞性疾病和胎盘早剥）、进展为重度高血压或蛋白尿和产后大出血（>1000 ml，失血）。按意向治疗进行分析，治疗效果以相对风险表示。结果756例患者被分配接受引产（n=377）或期待监测（n=379）。397例患者拒绝随机化，但允许使用其病历。在随机分组的妇女中，117例（31%）被分配到引产组，而166例（44%）被分配到期待监测组（相对风险0.71，95%CI 0.59-0.86，p
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