Role of Transvaginal Ultrasonography in Evaluating Premenopausal Women Aged More Than 35 Years With Abnormal Uterine Bleeding
试验速览
- 阶段
- 不适用
- 入组人数
- 560
- 试验地点
- 2
- 主要终点
- The accuracy of endometrial thickness and endometrial pattern detected by transvaginal ultrasound in predicting endometrial hyperplasia and endometrial cancer.
研究概览
简要总结
The objective of this study is to investigate the role of transvaginal ultrasound in detecting endometrial hyperplasia and endometrial cancer in women aged more than 35 presenting with abnormal uterine bleeding.
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
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal women aged over than 35
- •Abnormal uterine bleeding (menorrhagia/menometrorrhagia/metrorrhagia)
- •Accept transvaginal examination (pelvic examination and ultrasound)
- •Informed consent
排除标准
- •Severe uterine bleeding resulting in unstable vital signs
- •Pregnancy
- •Current medications: anticoagulants, selective serotonin reuptake inhibitor (SSRI), antipsychotics, corticosteroids, hormones, herbs
- •Intrauterine device
- •Genital tract pathologies: infection, submucous myoma distorting uterine cavity
- •Systemic diseases that may cause coagulopathies: Thyroid disease, liver disease, pituitary/ hypothalamus diseases
- •Not able to retrieve endometrial tissue
结局指标
主要结局
The accuracy of endometrial thickness and endometrial pattern detected by transvaginal ultrasound in predicting endometrial hyperplasia and endometrial cancer.
时间窗: 14 months
The endometrial thickness will be measured in millimeter, at the mid-sagittal plane of the uterus, near the uterine fundus. The measurement will be performed 3 times, from basal layer of the anterior to basal layer of the posterior wall of uterine cavity. The average value of 3 measurements will be used for statistical analysis. The endometrial patterns are categorized into 3 groups: 1. Triple-layer appearance 2. Mixed echogenic pattern 3. Hyper-echogenic pattern
次要结局
- To identify the cut-off points of endometrial thickness that can differentiate normal endometrial pathology and endometrial hyperplasia/endometrial cancer.(14 months)