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临床试验/NCT04308811
NCT04308811已完成2 期

Platelet-Rich Plasma in the Management of Asherman Syndrome

Ain Shams University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年8月10日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed I Amer

Professor

Ain Shams University

研究点 (1)

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