Platelet-Rich Plasma in the Management of Asherman Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Grade of intrauterine adhesions
研究概览
简要总结
The aim of the study is to find out the benefit of the platelet-rich plasma in preventing reformation of intrauterine adhesions after adhesiolysis in cases of Asherman syndrome
详细描述
Patients fulfilling criteria will be randomized into three equal groups. The patients who are diagnosed previously with severe AS will choose an envelope which determines the treatment method. There will be 60 envelops assigning for the groups mixed together in one box. This will ensure a randomized allocation of patients to either group of this study.
Hysteroscopy adhesiolysis will be done to all participants in the study. in the first group, Adhesiolysis will be followed by intrauterine use of PRP then insertion of intrauterine Foley balloon catheter that will be inflated and left for 2 weeks. in the second group, adhesiolysis will be followed by insertion of intrauterine Foley balloon catheter covered by freeze-dried amniotic graft and will be inflated and left for 2 weeks. In the third group, Adhesiolysis will be followed by insertion of intrauterine Foley balloon catheter that will be inflated and left for 2 weeks. All patients will be given antibiotics and hormonal treatment. Also, they will be given low dose aspirin and sildenafil 50mg daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Severe intrauterine synechia confirmed by hysteroscopy
- •age group from 20 to 40 years
排除标准
- •Hemoglobin less than 11 g/dl
- •Platelet less than 150000/mm3
- •Patients taking anticoagulants
- •Patients taking NSAID in the 15 days prior to the procedure
- •Active cervical or uterine infection
结局指标
主要结局
Grade of intrauterine adhesions
时间窗: after one month
Grade of intrauterine adhesions
次要结局
- menstruation(within three months postoperative)
研究者
Mohamed I Amer
Professor
Ain Shams University
