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首页> 外文期刊>Journal of minimally invasive gynecology >The Adiana System for permanent contraception: safety and efficacy at 3 years.
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The Adiana System for permanent contraception: safety and efficacy at 3 years.

机译:Adiana永久避孕系统:3年安全性和有效性。

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摘要

STUDY OBJECTIVE: To evaluate the efficacy of the Adiana System for preventing pregnancy in women desiring permanent sterilization. DESIGN: This study is a prospective, single-arm, multicenter, international trial. The primary endpoint was pregnancy prevention rate at 12 months. Pregnancy prevention rates at 24 and 36 months were also calculated (Canadian Task Force classification II-2). SETTING: The study was conducted at 16 sites, 14 in the United States, 1 in Australia, and 1 in Mexico. PATIENTS: A total of 645 women (intent-to-treat group). INTERVENTION: Hysteroscopic placement of polymer matrix was attempted in all patients. Tubal occlusion confirmed by hysterosalpingography at 12 weeks. Ongoing monitoring for pregnancy over 36 months. MEASUREMENTS AND MAIN RESULTS: There was a 95% bilateral matrix placement rate and 88.4% bilateral occlusion by hysterosalpingography, as previously reported. A total of 24 968 person-months of wearing were accrued. Pregnancy prevention rates were summarized with descriptive statistics by use of 95% two-sided confidence interval on the basis of life-table methods. Complete 36-month data were available for 481 subjects. During the first year, 6 pregnancies were reported. Three were determined to be the result of misinterpretation of hysterosalpingography results. The remaining 3 were attributed to method failure, as were the 3 pregnancies during the second year. No additional pregnancies occurred in year 3. The cumulative pregnancy prevention rates at 12, 24, and 36 months compare favorably with data from the Collaborative Review of Sterilization study and other published reports documenting efficacy of established permanent sterilization procedures. CONCLUSIONS: These data demonstrate that the efficacy of the Adiana System for pregnancy prevention is similar to other permanent sterilization methods.
机译:研究目的:评估Adiana系统在希望进行永久绝育的妇女中预防妊娠的功效。设计:这项研究是一项前瞻性,单臂,多中心的国际试验。主要终点指标是12个月妊娠预防率。还计算了24和36个月的预防怀孕率(加拿大工作组II-2级)。地点:该研究在16个地点进行,美国14个,澳大利亚1个,墨西哥1个。患者:645名女性(意向性治疗组)。干预:所有患者均尝试宫腔镜置入聚合物基质。十二指肠输卵管造影证实输卵管阻塞。持续监测怀孕36个月以上。测量和主要结果:如先前报道,子宫输卵管造影显示双侧基质放置率达95%,双侧闭塞率达88.4%。总共有24 968人月的穿着。根据寿命表方法,使用95%的双向置信区间,通过描述性统计总结了妊娠预防率。共有481个受试者的完整36个月数据。在第一年,报告了6次怀孕。三个被确定为子宫输卵管造影结果的误解的结果。其余3个原因是方法失败,第二年的3个怀孕也是如此。第3年没有再发生怀孕。在第12、24和36个月的累计预防怀孕率与《消毒合作评估》研究和其他已记录的报告的数据相吻合,该报告证明了已建立的永久性灭菌程序的有效性。结论:这些数据表明,阿迪亚娜系统预防妊娠的功效与其他永久性绝育方法相似。

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