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用于辅助性阴道分娩的OdonAssist充气装置 - - ASSIST II研究 (英国)
Emily J Hotton1, Nichola Bale2, Claire Rose2
1Women and Children's Research Centre, Southmead Hospital, North Bristol NHS Trust, Bristol, United Kingdom; Translational Health Sciences, University of Bristol, Southmead Hospital, Bristol, United Kingdom.
助产器显示出有希望的可行性和有效性,用于辅助性阴道分娩,成功率为66%,没有严重的不良事件. 这支持进一步的随机对照试验,将其与标准实践进行比较.
科学领域:
- 产科和妇科 产科和妇科
- 医疗器械 医疗器械
- 临床试验 临床试验
背景情况:
- 辅助性阴道分娩率正在下降,而剖腹产率正在上升.
- OdonAssist是一款创新的设备,旨在改善辅助性阴道分娩的结果.
- 之前的代重点是通过临床和设计调整来提高设备的有效性和可用性.
研究的目的:
- 评估OdonAssist设备的可行性,安全性和有效性.
- 为了确定OdonAssist是否证明未来的随机对照试验是合理的.
- 收集关于临床,患者报告和操作人员报告结果的初步数据.
主要方法:
- 这是一项非随机的开放性研究,涉及104名参与者,他们使用OdonAssist进行了辅助性阴道分娩.
- 包括同意但由于操作员可用性而没有接受干预的参与者的嵌套队列.
- 主要结局:成功的OdonAssist辅助分娩比例;次要结局:临床,患者,操作员,设备和医疗保健利用数据;母亲和新生儿结局至90天.
主要成果:
- 在66% (69/104) 的病例中,OdonAssist是有效的,达到预定义的疗效值.
- 在母亲或新生儿中没有报告与设备相关的严重不良反应或副作用.
- 新生儿软组织伤在成功的OdonAssist组 (4%) 与未成功的尝试 (20%) 和嵌套队列 (23%) 相比较低.
结论:
- 对新的辅助性阴道分娩设备进行干预研究的招聘是可行的,有64%的符合条件的参与者同意.
- OdonAssist的成功率支持其在随机对照试验中与当前的标准实践进行比较.
- 潜在的优势包括减少新生儿软组织损伤,并且该设备可以直接用于各种胎儿位置.
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