NCT01829451已完成不适用
Autocrosslinked Hyaluronic Acid Gel in Prevention of Intrauterine Adhesions After Bipolar Radiofrequency Endometrial Ablation: a Randomised, Controlled and Double Blind Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- prevention of intrauterine adhesion formation
研究概览
简要总结
The aim of the study is to evaluate if hyaluronic acid gel prevents intrauterine adhesion formation after endometrial thermal ablation.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 52 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •menorrhagia
排除标准
- •abnormal uterine cavity,
- •abnormal endometrial biopsy
研究组 & 干预措施
No hyaluronic acid gel
Placebo Comparator
An empty Pipelle device is taken into the uterus after endometrial ablation as an placebo procedure
Hyaluronic acid gel
Experimental
Hyaluronic acid gel is placed into the uterus after endometrial ablation
干预措施: Hyaluronic acid gel (Other)
结局指标
主要结局
prevention of intrauterine adhesion formation
时间窗: 3 months
The effect of hyaluronic acid gel on the formation of intrauterine adhesions after endometrial thermal ablation is assessed in an outpatient hysteroscopy after 3 months. Classification of intrauterine adhesions has been created for this study specifically.
次要结局
未报告次要终点
研究者
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