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临床试验/NCT04736095
NCT04736095已完成不适用

3 Dimensional Ultrasound in Comparison to Hysteroscopy in Diagnosis of Myomas

Aljazeera Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年2月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
The accuracy of 3D ultrasound in doiagnosis of submucous myomas in comparison to hysteroscopy

研究概览

简要总结

• three-dimensional saline infusion sonohysterography (3D SIS) was performed in all cases. A sterile Cuscoe speculum was passed, the cervix visualized and cleaned with sterile chlorhexidine solution. A 3.3 mm soft plastic paediatric naso-gastric suction catheter was then passed through the cervix into the uterine cavity without grasping the cervix.

详细描述

The speculum was removed and a 5 MHz transvaginal 3D ultrasound probe inserted into the vagina (Voluson 730; KretzTechnik, Austria).

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • • Women between 20 and 60 years with abnormal uterine bleeding in form of heavy menstrual bleeding, irregular and heavy menstrual bleeding) diagnosed on non-enhanced two-dimensional ultrasonography with submucous fibroids.
  • Absence of STD, PID, active vaginal bleeding.

排除标准

  • Presence of general cause of abnormal uterine bleeding
  • History of drug use that can cause vaginal bleeding (anticoagulants, OCPs, HRT)
  • History of recent hormonal treatment
  • High risk of undergoing hysteroscopy
  • Vaginal, Vulval causes of bleeding

结局指标

主要结局

The accuracy of 3D ultrasound in doiagnosis of submucous myomas in comparison to hysteroscopy

时间窗: one week

How many women will be diagnosed by 3D US to have submucous myoma

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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