Immediate delivery versus expectant monitoring for hypertensive disorders of pregnancy between 34 and 37 weeks of gestation (HYPITAT-II): an open-label, randomised controlled trial
Immediate delivery versus expectant monitoring for hypertensive disorders of pregnancy between 34 and 37 weeks of gestation (HYPITAT-II): an open-label, randomised controlled trial
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DOI：
10.1016/s0140-6736(14)61998-x
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发表时间：
2015-06-20
期刊：
影响因子：
168.9
通讯作者：
Langenveld, Josje
中科院分区：
文献类型：
--
作者：
Broekhuijsen, Kim;van Baaren, Gert-Jan;Langenveld, Josje
背景：对于晚期早产合并高血压疾病的妇女，没有什么证据可以指导其治疗。我们调查的效果，立即交付与期待监测产妇和新生儿的结局在这样women.Methods，我们做了一个开放标签，随机对照试验，在7个学术医院和44个非学术医院在荷兰。将妊娠34 - 37周的非重度妊娠高血压疾病妇女随机分配至24 h内引产或剖腹产（立即分娩）或旨在延长妊娠至37周的策略（期待监测）。主要结局是不良母体结局的复合（血栓栓塞性疾病、肺水肿、子痫、HELLP综合征、胎盘脱垂或孕产妇死亡）和新生儿呼吸窘迫综合征，两者均通过意向治疗进行分析。该研究在荷兰试验注册中心（NTR 1792）注册。897名妇女被邀请参加，其中703人被招募并随机分配到立即分娩（n=352）或期待监测（n=351）。在352名立即分娩的妇女中有4名（1.1%）发生了复合不良母体结局，而在351名期待监测的妇女中有11名（3.1%）发生了复合不良母体结局（相对风险[ RR] 0.36，95%CI 012-111; p=0069）。立即分娩组352名新生儿中有20名（5.7%）被诊断为呼吸窘迫综合征，而期待监测组351名新生儿中有6名（1.7%）被诊断为呼吸窘迫综合征（RR 3.3，95% CI 1.4-8.2; p=0.005）。解释对于妊娠34-37周的非严重高血压疾病的妇女，立即分娩可能会降低已经很小的不良孕产妇结局的风险。然而，它显着增加了新生儿呼吸窘迫综合征的风险，因此，常规立即交付似乎不合理，并期待监测，直到临床情况恶化的战略可以考虑。
Background There is little evidence to guide the management of women with hypertensive disorders in late preterm pregnancy. We investigated the effect of immediate delivery versus expectant monitoring on maternal and neonatal outcomes in such women.Methods We did an open-label, randomised controlled trial, in seven academic hospitals and 44 non-academic hospitals in the Netherlands. Women with non-severe hypertensive disorders of pregnancy between 34 and 37 weeks of gestation were randomly allocated to either induction of labour or caesarean section within 24 h (immediate delivery) or a strategy aimed at prolonging pregnancy until 37 weeks of gestation (expectant monitoring). The primary outcomes were a composite of adverse maternal outcomes (thromboembolic disease, pulmonary oedema, eclampsia, HELLP syndrome, placental abruption, or maternal death), and neonatal respiratory distress syndrome, both analysed by intention-to-treat. This study is registered with the Netherlands Trial Register (NTR1792).Findings Between March 1, 2009, and Feb 21, 2013, 897 women were invited to participate, of whom 703 were enrolled and randomly assigned to immediate delivery (n=352) or expectant monitoring (n=351). The composite adverse maternal outcome occurred in four (1.1%) of 352 women allocated to immediate delivery versus 11 (3.1%) of 351 women allocated to expectant monitoring (relative risk [ RR] 0.36, 95% CI 012-111; p=0069). Respiratory distress syndrome was diagnosed in 20 (5.7%) of 352 neonates in the immediate delivery group versus six (1.7%) of 351 neonates in the expectant monitoring group (RR 3.3, 95% CI 1.4-8.2; p=0.005). No maternal or perinatal deaths occurred.Interpretation For women with non-severe hypertensive disorders at 34-37 weeks of gestation, immediate delivery might reduce the already small risk of adverse maternal outcomes. However, it significantly increases the risk of neonatal respiratory distress syndrome, therefore, routine immediate delivery does not seem justified and a strategy of expectant monitoring until the clinical situation deteriorates can be considered.