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

We aimed to investigate the effect of screening for pre-eclampsia risk at 36 weeks' gestation and offering risk-stratified, planned, early-term birth.

我们旨在调查在妊娠36周时对子痫前期风险进行筛查，并根据风险分层提供计划性的早期足月分娩对降低子痫前期发生的影响。

Methods

PREVENT-PE was an open-label, adaptive (planned, for sample size), randomised controlled trial, done at two maternity hospitals in the UK.

PREVENT-PE 是一项在英国两家产科医院进行的开放标签、自适应（计划中的，用于样本量计算）、随机对照试验。

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.

我们纳入了年龄≥16岁的女性，她们有单胎妊娠、活胎且无重大畸形，并且能够提供知情同意，没有先兆子痫或参与冲突试验的情况。

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).

同意参加的女性通过中央计算机化服务（1:1，使用可变大小的随机排列块，按地点分层）随机分配到干预组（先兆子痫风险评估，对于有先兆子痫风险≥1/50的女性，进行风险分层的计划性早期足月分娩）或对照组（足月时的常规护理）。

The primary outcome was birth with pre-eclampsia (International Society for the Study of Hypertension in Pregnancy criteria).

主要结果是符合国际妊娠高血压研究学会标准的先兆子痫分娩。

This trial is registered with ISRCTN, ISRCTN41632964.

该试验已在ISRCTN注册，注册号为ISRCTN41632964。

Results

Of 11 280 women presenting for routine fetal ultrasound at 35+0 to 36+6 weeks' gestation between May 9, 2023, and June 7, 2024, 10 803 (95·8%) were eligible.

在2023年5月9日至2024年6月7日期间，共有11,280名孕妇在妊娠35+0至36+6周进行常规胎儿超声检查，其中10,803名（占95.8%）符合入选标准。

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.

在随机分配的8136名女性中（占75.3%），有6名（占0.1%）撤回了同意，另外36名（占0.4%）错误地被随机分配，最终分析中剩余8094名女性（占99.5%）：干预组有4037名（占49.9%）女性，对照组有4057名（占50.1%）女性。在8094名女性中，有2098名（占25.9%）自我报告为非白人种族，5996名（占74.1%）自我报告为白人种族。

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-treatanalysis with imputation).

在干预组的4037名分娩中，有158名（占3.9%）发生了子痫前期，在对照组的4057名分娩中，有226名（占5.6%）发生了子痫前期（调整后的风险比为0.70 [95% 置信区间0.58-0.86]；意向治疗分析并进行了估算）。

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).

两组间严重不良事件的发生率没有差异，干预组（4031人中有5例[0.1%]）与对照组（4048人中有10例[0.2%]；费舍尔精确检验p=0.30）。

interpretation

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

基于子痫前期风险分层的计划性早产降低了子痫前期的发生率，且没有增加急诊剖宫产或新生儿护理单元的入院率。

funding

Fetal Medicine Foundation.

胎儿医学基金会。