Amnion Graft for Preventing Intrauterine Adhesions Following Hysteroscopic Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- safety of intrauterine application of amnion membrane
研究概览
简要总结
The purpose of the study is to evaluate whether human amnion graft reduces the reformation of severe intrauterine adhesions (IUA) following hysteroscopic adhesiolysis.
详细描述
Background
IUA is a consequence of trauma to the endometrium, producing partial or complete obliteration in the uterine cavity and/or the cervical canal, resulting in conditions such as menstrual abnormalities, infertility, and recurrent pregnancy loss. The outcome of hysteroscopic adhesiolysis for IUA is significantly affected by recurrence of intrauterine adhesions. The IUA research should be directed toward reduction of adhesion reformation with a view to improve outcome.
The reformation of intrauterine adhesions appears to be directly related to the severity of the adhesions. It has been reported that the recurrence rate for intrauterine adhesions ranges from 3.1% to 23.5% among all cases of intrauterine adhesions and from 20% to 62.5% in those with severe adhesions.
In this study, considering the high recurrent rate in severe IUA, investigator will focus on severe IUA cases.
Up to now several strategies are commonly employed by various investigators after division of intrauterine adhesions:
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •patients scheduled for adhesiolysis of intrauterine adhesions
- •patients willing to undergo followed hysteroscopy about 4 and 12 weeks after the surgery to assess the reformation of intrauterine adhesions.
- •Written, informed consent obtained.
排除标准
- •ongoing pregnancy
- •Peroperative fever or infections
- •Malignancy
- •Precious pelvic inflammatory disease
- •Uterine fibroid (>3cm size)
- •endometriosis
- •Contraindications for anesthesia
- •Not able to read and/or understand informed consent.
研究组 & 干预措施
amnion graft in severe IUA
patients, who are with severe IUA, treated by uterine application of amnion membrane + Foley balloon+ hormones (Femoston) following hysteroscopic adhesiolysis.
干预措施: Uterine application of amnion membrane (Procedure)
amnion graft in severe IUA
patients, who are with severe IUA, treated by uterine application of amnion membrane + Foley balloon+ hormones (Femoston) following hysteroscopic adhesiolysis.
干预措施: Foley balloon (Device)
amnion graft in severe IUA
patients, who are with severe IUA, treated by uterine application of amnion membrane + Foley balloon+ hormones (Femoston) following hysteroscopic adhesiolysis.
干预措施: Femoston (Drug)
non-amnion graft in severe IUA
patients, who are with severe IUA, treated by Foley balloon+ hormones (Femoston) following hysteroscopic adhesiolysis.
干预措施: Foley balloon (Device)
non-amnion graft in severe IUA
patients, who are with severe IUA, treated by Foley balloon+ hormones (Femoston) following hysteroscopic adhesiolysis.
干预措施: Femoston (Drug)
结局指标
主要结局
safety of intrauterine application of amnion membrane
时间窗: 3 months
patients treated by amnion membrane following their hysteroscopic procedure were followed for immediate and late adverse effect: fever, abnormal vaginal discharge, pelvic pain, increased intrauterine adhesion formation upon follow up and changes in menstrual pattern.
次要结局
- efficacy of intrauterine application of amnion graft in reducing adhesion formation following hysteroscopic adhesiolysis.(3 months)
研究者
XUEBING PENG
Associated Professor
Capital Medical University