预防PE (通过按时分娩预防产前):一个随机试验的协议
James Goadsby1, Siddesh Shetty2, Argyro Syngelaki3
1Harris Birthright Research Centre for Fetal Medicine, King's College Hospital, London, UK.
Pregnancy hypertension
|April 11, 2025
概括
该PREVENT-PE试验调查是否查前 (PE) 风险,并提供早产可降低PE发病率. 这项研究旨在为高风险怀孕的产妇护理计划和分娩决策提供信息.
科学领域:
- 产科和妇科 产科和妇科
- 孕产妇和胎儿医学 孕产妇和胎儿医学
- 临床试验研究 临床试验研究
背景情况:
- 孕前 (PE) 是孕产妇和新生儿发病率的一个重要原因.
- 目前的管理往往涉及到期望护理到期,有潜在的不良结果.
研究的目的:
- 评估是否在怀孕35周至36周之间对术前 (PE) 风险进行查,再加上基于风险的计划早产,可以降低PE发生率.
- 评估基于风险的短期PE干预措施的有效性和成本效益.
主要方法:
- PREVENT-PE研究是一项多中心,随机对照试验,将干预组 (PE风险查和计划早产) 与对照组 (常规护理) 进行比较.
- 参与者是单独怀孕,在35+0和36+6周怀孕之间进行例行超声波检查.
- 随机化是1:1的,计划样本大小为4000-8000名参与者,使用适应性设计.
主要成果:
- 主要结局是根据ISSHP 2021标准,出生时患有先兆子 (PE).
- 二次结局包括紧急剖腹产和新生儿病房入院时间≥48小时.
- 经济评估将从医疗服务的角度评估成本效益和成本效益.
结论:
- 预计PREVENT-PE试验将提供关键数据,以主动,基于风险的方法来管理妊娠前的好处和成本.
- 研究结果将为临床决策提供有关产生的时间和孕产妇服务的信息,这些服务适用于PE风险的怀孕.
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