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使用单手插入器放置T380A宫内铜避孕器

Rebecca F Dunsmoor-Su¹, Vrunda B Desai¹, Erica C Pandolfi¹

¹Seattle Clinical Research Center, Seattle, Washington; CooperSurgical, Inc., Trumbull, Connecticut; South Miami Hospital, Miami, Florida; Emory University, Atlanta, Georgia; Hilltop OB GYN, Cincinnati, Ohio; and McKain Consulting LLC, San Antonio, Texas.

|September 26, 2025

概括

在临床试验中,Paragard T380A宫内铜避孕装置的新单手插入器在临床试验中显示出99.1%的成功率. 该设备易于使用,安全用于子宫内系统插入.

科学领域:

避孕和计划生育与计划生育.
医疗器械技术医疗器械技术
临床妇科临床妇科

背景情况:

临床试验.gov的标识符:NCT05309694.gov的标识符:NCT05309694.gov的标识符:NCT05309694.gov的标识符:
对Paragard T380A子宫内铜避孕装置的一种新型预组装,单手插入器的评估.

研究的目的:

评估Paragard T380A子宫内铜避孕装置的单手插入器的插入成功和安全性.
评估与新型插入器相关的易用性和插入时间.

主要方法:

第4期多中心研究涉及117名参与者.
研究了第一和第二次尝试的插入成功率.
监控与插入程序相关的安全信号.

主要成果:

整体插入成功率为99.1% (116/117名参与者).
90.6% (106/117) 在第一次尝试中成功插入.
调查人员报告说使用方便,并感觉到插入时间缩短.
没有观察到与插入直接相关的安全信号.

结论:

帕拉加德T380A宫内铜避孕装置的单手插入器是IUS插入的有效和安全的.
该设备为医疗保健提供者提供了高成功率和易于使用的设备.
进一步监测罕见的不良事件,如子宫穿孔,是很重要的.

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