：，这一成果由国王学院Kypros H Nicolaides研究团队经过不懈努力而取得。该研究于2025年12月4日发表于国际一流学术期刊《柳叶刀》杂志上。

背景:在高危妊娠中，没有可靠的干预措施来减少足月先兆子痫。研究人员的目的是研究在妊娠36周筛查先兆子痫风险的效果，并提供风险分层、计划、早期分娩。

方法:PREVENT-PE是一项开放标签、自适应（按样本量计划）、随机对照试验，在英国的两家妇产医院进行。研究小组纳入了单胎妊娠、活胎无重大异常、能够提供知情同意、无先兆子痫或参与相互矛盾的试验的妇女（年龄≥16岁）。同意的妇女被随机分配到干预组（子痫前期风险评估，对于子痫前期风险≥1 / 50的妇女，进行风险分层计划早产）或对照组（足月常规护理）（通过中央计算机化服务，1:1，随机排列大小不等，按地点分层）。主要结局是出生时患有先兆子痫（国际妊娠高血压研究协会标准）。该试验已在ISRCTN注册，编号为ISRCTN41632964。

发现:2023年5月9日至2024年6月7日期间，11280名妊娠35+0至36+6周的妇女进行常规胎儿超声检查，10803例（95.8%）符合条件。在随机分配的8136名妇女（75.3%）中，6名（0.1%）撤回同意，36名（0.4%）随机分配错误，最终分析结果为8094名（99.5%）：干预组4037名（49.9%）妇女，对照组4057名（50.1%）妇女。8094名女性中有2098名（25.9%）自报非白种人，5996名（74.1%）自报白种人。干预组4037例新生儿中有158例（3.9%）发生先兆子痫，对照组4057例新生儿中有226例（5.6%）发生先兆子痫（校正风险比0.70；意向-治疗分析与归算）。严重不良事件在干预组（5例[0.1%]，共4031例）和对照组（10例[0.2%]，共4048例；Fisher's精确检验p= 0.30）之间无差异。

研究结果表明，基于先兆子痫风险分层的计划早产降低了先兆子痫的发生率，没有增加紧急剖腹产或新生儿护理病房的入院率。

附：英文原文

Title: Scheduled birth at term for the prevention of pre-eclampsia (PREVENT-PE): an open-label randomised controlled trial

Author: James Goadsby, Argyro Syngelaki, Laura A Magee, Peter von Dadelszen, Ranjit Akolekar, Sophie Webster, Alan Wright, David Wright, Kypros H Nicolaides

Issue&Volume: 2025-12-04

Abstract: Background

In high-risk pregnancies, there is no reliable intervention to reduce term pre-eclampsia. We aimed to investigate the effect of screening for pre-eclampsia risk at 36 weeks' gestation and offering risk-stratified, planned, early-term birth.

Methods

PREVENT-PE was an open-label, adaptive (planned, for sample size), randomised controlled trial, done at two maternity hospitals in the UK. We included women (aged ≥16 years) with a singleton pregnancy, live fetus without major anomalies, and ability to provide informed consent, without pre-eclampsia or participation in conflicting trials. Consenting women were randomly assigned (by a central computerised service, 1:1, in random permuted blocks of variable size, stratified by site) to the intervention group (pre-eclampsia risk assessment and, for women with a pre-eclampsia risk ≥1 in 50, risk-stratified planned early-term birth) or control group (usual care at term). The primary outcome was birth with pre-eclampsia (International Society for the Study of Hypertension in Pregnancy criteria). This trial is registered with ISRCTN, ISRCTN41632964.

Findings

Of 11280 women presenting for routine fetal ultrasound at 35+0 to 36+6 weeks' gestation between May 9, 2023, and June 7, 2024, 10803 (95·8%) were eligible. Of 8136 women (75·3%) randomly assigned, six (0·1%) withdrew consent and 36 (0·4%) were randomly assigned in error, leaving 8094 (99·5%) in the final analyses: 4037 (49·9%) women in the intervention group and 4057 (50·1%) in the control group. 2098 (25·9%) of 8094 women self-reported non-White ethnicity and 5996 (74·1%) self-reported White ethnicity. Pre-eclampsia occurred in 158 (3·9%) of 4037 births in the intervention group and in 226 (5·6%) of 4057 in the control group (adjusted risk ratio 0·70 [95% CI 0·58–0·86]; intention-to-treat analysis with imputation). Serious adverse events did not differ between the intervention group (five [0·1%] of 4031) and control group (ten [0·2%] 4048; Fisher's exact test p=0·30).

Interpretation

Planned early-term birth based on risk stratification for pre-eclampsia reduced the incidence of pre-eclampsia, without increasing emergency caesarean section or neonatal care unit admission.

DOI: 10.1016/S0140-6736(25)01207-3

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)01207-3/abstract