Intercoat (Oxiplex/AP Gel) for Preventing Intrauterine Adhesions Following Operative Hysteroscopy for Suspected Retained Products of Conception - a Prospective Randomized Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- safety of intrauterine application of Intercoat
研究概览
简要总结
This is a prospective single blind randomized controlled pilot study was designed to investigate whether the biological barrier Intercoat (Oxiplex/AP gel) reduces formation of intrauterine adhesions following hysteroscopic treatment for retained products of conception.
详细描述
Thirty women randomly divided equally into those who received Intercoat following hysteroscopic treatment for retained products of conception (study group) and those who did not receive the gel (controls). Safety and efficacy of the preparation were evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 50 years
- •Availability of the results of vaginal ultrasound or diagnostic hysteroscopy
排除标准
- •Signs of infection upon admission
- •Ongoing pregnancy
研究组 & 干预措施
Intercoat treatment
women treated by Intercoat gel following hysteroscopy for retained products of conception
干预措施: Oxiplex/AP gel (Drug)
Control group
No additional treatment following hysteroscopy was performed
干预措施: Normal Saline (Drug)
结局指标
主要结局
safety of intrauterine application of Intercoat
时间窗: 18 months
women treated by Intercoat following their hysteroscopic procedure were followed for immediate and late adverse effects; fever, increased intrauterine adhesion formation upon follow up and changes in menstrual pattern
次要结局
- efficacy of intrauterine application of Intercoat gel in reducing adhesion formation following hysteroscopic treatment for retained products of conception(14 months)