在双胞胎中计划分娩的产前皮质类固醇随机控制的安慰剂试验 (STOPPIT-3):研究协议
Sarah Murray1, Jessica Thompson2, Rosie C Townsend2
1Centre for Reproductive Health, The University of Edinburgh, Edinburgh, UK sarah.murray@ed.ac.uk.
BMJ open
|January 18, 2024
概括
这项研究评估了双胞胎怀孕的产前皮质类固醇 (ACS),评估其有效性和成本在计划分娩之前. 结果将为双胞胎提供最佳护理,改善呼吸系统结果和长期发展.
科学领域:
- 产科和妇科 产科和妇科
- 新生儿医学 新生儿医学
- 临床试验 临床试验
背景情况:
- 产前皮质类固醇 (ACS) 对胎儿肺部成熟至关重要.
- 它们在接近期的双胞胎怀孕中使用需要进一步评估,以获得最佳的利益风险平衡.
研究的目的:
- 为了确定双胞胎怀孕的妇女在ACS的临床和成本效益.
- 评估ACS对新生儿呼吸支需求的影响.
主要方法:
- 一个多中心,双盲,随机,安慰剂控制的试验,涉及1552名双胞胎怀孕的妇女.
- 参与者在计划分娩前24-120小时接受了甲酸或盐水,在怀孕35周至38周+6周之间.
- 主要结局:在出生后72小时内需要呼吸辅助;次要结局包括2年的认知和语言发展.
主要成果:
- 主要结果数据的收集正在进行中.
- 二次结果数据的收集正在进行中.
- 在临床数据收集完成后,将进行成本效益分析.
结论:
- STOPPIT-3试验将为双胞胎怀孕产前皮质类固醇的疗效和成本效益提供关键证据.
- 结果将指导临床实践和政策,用于管理晚期早产双胞胎的出生.
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