Hysteroscopic Septoplasty by Different Modalities: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Need for second intervention
研究概览
简要总结
The goal of this clinical trial is to compare in participant population ( women with uterine septum meeting the inclusion criteria) hysteroscopic septoplasty by resectoscope compared to hysteroscopic septoplasty with scissors.
The main questions to answer are:
Is there a difference in operative time ? Is there a difference in fluid used and fluid deficit? Is there a difference in complications? Is there a difference in reproductive outcome? Researchers will compare the 2 different techniques to see if there is any difference in operative outcome ( operative time, fluid used and deficit, need for second intervention, and operative and postoperative complications) and reproductive outcome.
详细描述
Study design:
Prospective randomized clinical trial
Study duration and location:
For at least 24 months, Patients admitted to Obstetrics and Gynecology department at Mansoura University Hospital.
Study method
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women of reproductive age
- •Seeking conception
- •Diagnosis of a septate or subseptate uterus
- •A history of one of the following:
- •Recurrent pregnancy loss
- •Subfertility
- •Preterm Birth
排除标准
- •Not seeking conception
- •Diagnosis of septate or subseptate uterus with no history of any of the following:
- •Recurrent pregnancy loss
- •Subfertility
- •Preterm Birth
- •Contraindications for surgery
- •Those who refused to participate.
结局指标
主要结局
Need for second intervention
时间窗: 3 months follow up after intervention
Operative and post operative complications
时间窗: 3 months follow up after intervention
Operative time
时间窗: During surgery
Fluid deficit
时间窗: During surgery
次要结局
- Pregnancy rate(At least 6 months follow up after intervention)
- Live birth rate(Follow up until the end of first clinical pregnancy or 6 months after surgery)
研究者
Ahmed Moustafa Alsayed Alamely
Assistant lecturer of Obstetrics and Gynecology
Mansoura University Hospital