Ultrasonographic Appearance of the Endometrium After Saline Infusion in Women Presenting With a Thickened Endometrium After the Use of Ulipristalacetate.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- ultrasonographic morphology of the endometrium at saline infusion sonography
研究概览
简要总结
If endometrial thickening is visualised (>10mm) after the use of ulipristalacetate in case of medical treatment for uterine fibroids a saline infusion and sonographic examination will be performed to evaluate the endometrium and exclude intra-uterine pathology.
详细描述
When ultrasonographic examination during follow up of a treatment with ulipristalacetate shows a thickening of the endometrium of 10mm or more ( thickening described in 10% of ulipristalacetate users and is completely benign), a saline infusion can help to exclude pathology in the uterine cavity. Saline infusion helps to better delineate the uterine cavity and endometrium. If fibroids or polyps are present in the uterine cavity they will clearly be seen.
This study was set up to describe how the endometrial changes after Esmya use appear on saline infusion sonography. This study can help to recognize ultrasonographic images in women presenting with thickened endometrium after Ulipristalacetate use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with thickened endometrium on ultrasound (defined as double endometrium thickness of ≥10mm) at the end of their treatment with ulipristalacetate.
- •Normal double endometrium thickness before the use of ESMYA (<10mm)
- •BMI >18 - < 30
排除标准
- •Known type 0 or 1 fibroids
- •Known intrauterine pathology
结局指标
主要结局
ultrasonographic morphology of the endometrium at saline infusion sonography
时间窗: 1 week
thickness and appearance of the endometrium
次要结局
- diagnostic ability to exclude intrauterine pathology(1week)
研究者
Stefan Cosyns
MD
Universitair Ziekenhuis Brussel