英国伦敦国王学院Lucy C Chappell研究小组对晚期先兆子痫计划提前分娩或预期管理（常规护理）的结局进行了比较。2019年8月28日，《柳叶刀》在线发表了这项成果。
研究组在英格兰和威尔士的46个产科单位进行了一项平行组、非屏蔽、多中心的随机对照试验，比较了妊娠34至37周的晚期先兆子痫患者和单绒毛膜双羊膜囊或双绒毛膜双羊膜囊的双胎孕妇。主要产妇结局定义为产妇发病或收缩压超过160毫米汞柱的综合结果，主要围产期结局定义为围产儿死亡或新生儿住院至出院的综合结果。
2014年9月29日至2018年12月10日，共招募女性901人。将450名孕妇分配到计划分娩组，451名孕妇分配到预期管理组。计划分娩组的主要产妇结局发生率为65%（289名），显著低于预期管理组（338名，75%），校正后相对风险为0.86。计划分娩组主要围产期结局的发生率为42%（196名婴儿），显著高于预期分娩组（159名婴儿，34%），相对风险为1.26。每个方案分析的结果均相似。计划分娩组有9例严重不良事件，预期治疗组有12例。
强有力的证据表明，与预期管理相比，计划分娩降低了产妇发病率和严重高血压率，更多的新生儿住院与早产有关，但没有迹象表明新生儿发病率更高。这种权衡应与晚期早产先兆子痫的孕妇共同讨论，以决定分娩时间。
研究人员表示，对于晚期先兆子痫的孕妇，最佳分娩时间尚不清楚，因为母体疾病进展的局限性需要与婴儿的并发症相平衡。
附：英文原文
Title: Planned early delivery or expectant management for late preterm pre-eclampsia (PHOENIX): a randomised controlled trial
Author: Prof Lucy C Chappell, PhD, Prof Peter Brocklehurst, FRCOG, Marcus E Green, et al
Issue&Volume: 28 August 2019
Summary:
Background
In women with late preterm pre-eclampsia, the optimal time to initiate delivery is unclear because limitation of maternal disease progression needs to be balanced against infant complications. The aim of this trial was to determine whether planned earlier initiation of delivery reduces maternal adverse outcomes without substantial worsening of neonatal or infant outcomes, compared with expectant management (usual care) in women with late preterm pre-eclampsia.
Methods
In this parallel-group, non-masked, multicentre, randomised controlled trial done in 46 maternity units across England and Wales, we compared planned delivery versus expectant management (usual care) with individual randomisation in women with late preterm pre-eclampsia from 34 to less than 37 weeks' gestation and a singleton or dichorionic diamniotic twin pregnancy. The co-primary maternal outcome was a composite of maternal morbidity or recorded systolic blood pressure of at least 160 mm Hg with a superiority hypothesis. The co-primary perinatal outcome was a composite of perinatal deaths or neonatal unit admission up to infant hospital discharge with a non-inferiority hypothesis (non-inferiority margin of 10% difference in incidence). Analyses were by intention to treat, together with a per-protocol analysis for the perinatal outcome. The trial was prospectively registered with the ISRCTN registry, ISRCTN01879376. The trial is closed to recruitment but follow-up is ongoing.
Findings
Between Sept 29, 2014, and Dec 10, 2018, 901 women were recruited. 450 women (448 women and 471 infants analysed) were allocated to planned delivery and 451 women (451 women and 475 infants analysed) to expectant management. The incidence of the co-primary maternal outcome was significantly lower in the planned delivery group (289 [65%] women) compared with the expectant management group (338 [75%] women; adjusted relative risk 0·86, 95% CI 0·79–0·94; p=0·0005). The incidence of the co-primary perinatal outcome by intention to treat was significantly higher in the planned delivery group (196 [42%] infants) compared with the expectant management group (159 [34%] infants; 1·26, 1·08–1·47; p=0·0034). The results from the per-protocol analysis were similar. There were nine serious adverse events in the planned delivery group and 12 in the expectant management group.
Interpretation
There is strong evidence to suggest that planned delivery reduces maternal morbidity and severe hypertension compared with expectant management, with more neonatal unit admissions related to prematurity but no indicators of greater neonatal morbidity. This trade-off should be discussed with women with late preterm pre-eclampsia to allow shared decision making on timing of delivery.
DOI: https://doi.org/10.1016/S0140-6736(19)31963-4
Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)31963-4/fulltext#
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本期文章：《柳叶刀》：Online/在线发表
