Intrauterine Adhesions Prevention: the Use of Heparin Solution Compared to Application of Anti-adhesion Barrier Gel After Operative Hysteroscopy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of patients with persistent irregular menstrual bleeding
研究概览
简要总结
The aim of this study is to compare the efficacy of intrauterine application of heparin solution to the use of hyaluronic acid barrier gel for the prevention of intrauterine adhesion formation after operative hysteroscopy.
详细描述
In this trial the investigators aim to evaluate and compare the effect of heparin solution to anti-adhesive hyaluronic barrier gel administration immediately after operative hysteroscopy on post-surgical complications (incidence, extent and severity of intrauterine adhesions, abnormal menstrual cycle pattern) and fertility.
Patients undergoing operative hysteroscopy will be identified and invited to participate in the trial. At 4 to 8 weeks after the initial surgery, a follow-up, diagnostic hysteroscopy will be performed to identify indications for subsequent operative procedure and classify intrauterine adhesions according to extent of uterine cavity affected and type of formation found. Data on subsequent persistent irregular menstrual bleeding and pregnancy success up to 12 months following treatment will also be collected.
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)
盲法说明
Patients will be under general anaesthesia during surgical procedure when the allocated treatment will be administered.
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female sex
- •indication for operative hysteroscopy including one or more of the following:
- •infertility,
- •irregular bleeding,
- •oligo-/amenorrhea,
- •Asherman syndrome,
- •G0-G3 fibroids,
- •dysmorphic uterus.
排除标准
- •ongoing pregnancy,
- •genital cancer,
- •pelvic inflammatory disease,
- •excessive uterine bleeding.
研究组 & 干预措施
Heparin solution
Administration of 3 ml heparin solution into the uterine cavity via a syringe immediately post operative hysteroscopy.
干预措施: Heparin solution (Drug)
Anti-adhesion barrier gel
Intrauterine application of 2 ml biodegradable anti-adhesion barrier gel immediately post operative hysteroscopy.
干预措施: Anti-adhesion barrier gel (Drug)
结局指标
主要结局
Number of patients with persistent irregular menstrual bleeding
时间窗: up to 12 months post treatment
Recurring abnormal menstrual cycle patterns identified post initial surgery
Number of patients with post-operative intrauterine adhesion formation
时间窗: 4 to 8 weeks post treatment
Incidence and severity of intrauterine adhesions identified at follow-up diagnostic hysteroscopy as assessed according to Valle and Sciarra's classification of intrauterine synaechia
Number of patients with need for subsequent operative hysterectomy
时间窗: 4 tot 8 weeks post treatment
Pathological findings at second-look hysteroscopy taken as indication for successive uterine surgery
次要结局
- Number of patients with fertility improvement(up to 12 months post treatment)