Background:Preeclampsia is associated with maternal and perinatal morbidity. Besides acute therapy for severe hypertension, best practices are lacking for intrapartum hypertension management. Our objective was to test the hypothesis that intrapartum initiation of extended-release nifedipine in individuals with preeclampsia with severe features prevents severe hypertension.Methods:Randomized, triple-blind, placebo-controlled trial of individuals with preeclampsia with severe features undergoing labor induction between 22^0/7 and 41^6/7 weeks gestation. Participants were randomized to oral extended-release nifedipine 30 mg or identical placebo every 24 hours. Primary outcome is defined as receipt of ≥1 dose of acute hypertension therapy for severe blood pressure (≥160/110 mm Hg) sustained ≥10 minutes. Secondary outcomes included route of delivery, neonatal intensive care unit admission, and a composite of adverse neonatal outcomes.Results:Of 365 individuals screened, 55 were randomized to nifedipine and 55 to placebo. Primary outcome was observed in 34.0% of individuals in nifedipine group versus 55.1% in placebo group (relative risk [RR] 0.62 [95% CI, 0.39–0.97]); number needed to treat to prevent receipt of acute treatment was 4.7 (95% CI, 2.5–44.3). Fewer individuals in nifedipine group required cesarean delivery compared with placebo group (20.8% versus 34.7%, RR, 0.60 [95% CI, 0.31–1.15]). Neonatal intensive care unit admission rate was lower in nifedipine group compared with placebo (29.1% versus 47.1%; RR 0.62 [95% CI, 0.37–1.02]). Neonatal composite was similar between groups (35.8% versus 41.2%, RR, 0.83 [95% CI, 0.51–1.37]).Conclusions:Initiation of extended-release nifedipine is effective in reducing intrapartum acute hypertensive therapy among individuals with preeclampsia with severe features.REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT04392375.

中文翻译：

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产时缓释硝苯地平预防重度先兆子痫孕妇重度高血压的试验

背景：先兆子痫与孕产妇和围产期发病率有关。除了严重高血压的急性治疗外，还缺乏产时高血压管理的最佳实践。我们的目的是检验这样一个假设，即在具有严重特征的先兆子痫患者中，分娩时开始使用缓释硝苯地平可预防严重高血压。方法：对具有严重特征的先兆子痫患者进行的引产的随机、三盲、安慰剂对照试验在 22 岁之间进行。^0/7和 41 ^6/7周妊娠。参与者被随机分配到每 24 小时口服缓释硝苯地平 30 mg 或相同的安慰剂。主要结果定义为接受 ≥ 1 剂量的急性高血压治疗，严重血压 (≥ 160/110 mm Hg) 持续 ≥ 10 分钟。次要结局包括分娩途径、新生儿重症监护病房入院率以及不良新生儿结局的综合结果。结果：在筛选的 365 名个体中，55 名随机分配至硝苯地平组，55 名分配至安慰剂组。硝苯地平组 34.0% 的个体观察到主要结果，而安慰剂组为 55.1%（相对风险 [RR] 0.62 [95% CI, 0.39–0.97]）；为防止接受急性治疗而需要治疗的人数为 4.7（95% CI，2.5–44.3）。与安慰剂组相比，硝苯地平组需要剖宫产的人数较少（20.8% 对 34.7%，RR，0. 60 [95% CI, 0.31–1.15])。与安慰剂组相比，硝苯地平组的新生儿重症监护病房入住率较低（29.1% 对 47.1%；RR 0.62 [95% CI，0.37–1.02]）。新生儿组合在组间相似（35.8% 对 41.2%，RR，0.83 [95% CI，0.51–1.37]）。结论：开始使用缓释硝苯地平可有效减少具有严重特征的先兆子痫患者的产时急性高血压治疗.注册：网址：https://www.clinicaltrials.gov；唯一标识符：NCT04392375。启动缓释硝苯地平可有效减少具有严重特征的先兆子痫患者的产时急性高血压治疗。注册：URL：https://www.clinicaltrials.gov；唯一标识符：NCT04392375。启动缓释硝苯地平可有效减少具有严重特征的先兆子痫患者的产时急性高血压治疗。注册：URL：https://www.clinicaltrials.gov；唯一标识符：NCT04392375。