NCT02733081撤回不适用
Simplified IUD Insertion Technique: A Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Correct IUD Placement Immediately Post-Insertion
研究概览
简要总结
This is a randomized controlled trial that compares traditional IUD insertion with that of a no uterine sound, no bimanual pelvic exam approach. The investigators hypothesis is that IUD placement is safe and effective without pre-procedural assessment of uterine size, direction, or depth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women 18 years and older presenting to contraceptive clinic in Gaborone, Botswana for IUD insertion and have ability to give informed consent.
排除标准
- •Known contradictions to copper IUD, inability to comply with study protocol
结局指标
主要结局
Correct IUD Placement Immediately Post-Insertion
时间窗: Immediately post-insertion
Percent of correct IUD placements between control (traditional IUD insertion) and experimental (simplified IUD insertion) groups at time of insertion as visualized by transvaginal ultrasound.
次要结局
- Patient Pain Scores (VAS)(Immediately Post-Insertion)
- Correct IUD Placements 4-6 Weeks Post-Insertion(4-6 weeks post-insertion)
- Patient Satisfaction with IUD Insertion(Immediately Post-Insertion)
研究者
Paul D Blumenthal
Principal Investigator
Stanford University
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