Comparison Between 3D Saline Infusion Sonohystrography and Office Hysteroscopy in the Evaluation of Patients With Irregular Uterine Bleeding
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- effectiveness of SIS versus office hysteroscopy in the diagnosis of cause of AUB
研究概览
简要总结
comparing the efficacy of the 3D saline infusion sonohysterography to the diagnostic office hysteroscopy in the diagnosis of the cause of abnormal uterine bleeding in females during their reproductive age
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •female aged between 20 and 45 years
- •with no medical disorders
- •approving to participate in the study
排除标准
- •vaginal or cervical lesions
- •history or suspicion of PID
- •IUD users
- •bleeding disorders
- •on anticoagulant therapy
- •irregular use of oral contraceptive pills
研究组 & 干预措施
Office hysteroscopy
after undergoing 3D SIS, cases would undergo office hysteroscopy and the investigator would be blinded to the results of SIS
干预措施: Office Hysteroscopy (Device)
3D saline infusion sonohysterography
participants presenting with abnormal uterine bleeding will undergo 3D saline infusion sonohysterography
干预措施: 3D saline infusion sonohysterography (Device)
结局指标
主要结局
effectiveness of SIS versus office hysteroscopy in the diagnosis of cause of AUB
时间窗: 6 months
The results of the two procedures would be compared with the operative findings and later histopathological assessment of the specimens
次要结局
未报告次要终点
研究者
Dina Mohamed Refaat Dakhly
Assistant Professor Obstetrics and Gynecology
Woman's Health University Hospital, Egypt