Simplified IUD Insertion Technique: A Randomized Controlled Trial
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
研究组 & 干预措施
Arm 1: Traditional IUD Insertion
Standard IUD insertion according to package insert. Bimanual pelvic exam to assess uterine size and position will be performed. Uterine sound will be used to measure depth of uterus prior to insertion.
Arm 2: Simplified IUD Insertion
Simplified, investigational IUD insertion performed. No bimanual pelvic exam or uterine sounding.
干预措施: Simplified IUD Insertion (Procedure)
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