NCT04975373Unknown不适用
Reduction of Intrauterine Adhesions by Intrauterine Hyaluronic Acid Gel After Hysteroscopic Removal of Retained Products of Conception: Multicenter Prospective Randomized Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- any adhesions
研究概览
简要总结
Women undergoing operative hysteroscopy for removal of retained placenta after delivery will be randomized into two groups.
- study group - immediately after operative hysteroscopy 5 ml hyaluronic acid gel will be injected into uterine cavity
- control group - no injection
4-8 weeks after operative hysteroscopy, participants will undergo diagnostic hysteroscopy with no anesthesia , as a part of routine evaluation after removal of retained placenta in Israel.
during diagnostic hysteroscopy the uterine cavity will be evaluated and the presence of adhesions and severity of adhesions will be recorded.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women undergoing hysteroscopic removal of retained placenta after delivery
排除标准
- •Known adverse reaction or allergy to hyaluronic acid
- •History of intrauterine adhesions
- •Acute pelvic inflammatory disease
研究组 & 干预措施
study group
Other
study group women in this group will receive intrauterine hyaluronic acid injection after operative hysteroscopy
干预措施: Intrauterine injection of hyaluronic acid (Drug)
结局指标
主要结局
any adhesions
时间窗: 4-8 weeks after intervention
presence of any adhesions in uterine cavity during diagnostic hysteroscopy
次要结局
- adhesion scorring(4-8 weeks after intervention)
研究者
研究点 (1)
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