The value of CA 125 as a biomarker for assessing the severity of Dysmenorrhea and Menorrhagia in Adenomyosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- VAS Score
研究概览
简要总结
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After approval from CTRI, the participants will be recruited. All women in the inclusion criteria will be recruited in the study who fulfill required criteria and informed consent
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All women will be graded based on VAS score and PABC score and USG findings as per MUSA’s criteria in USG
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Assessment of the clinicopathological findings (age, adenomyotic lesion volumes, uterus volumes, subcutaneous fat thickness, CA125 level) and dysmenorrhea by odds ratios (ORs) and tabulation of the same
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The information will be collected using a questionnaire and tabulated for further analysis. The total number of visits is limited to one and he information collected along with blood tests will be evaluated.
-This study will determine the relationship of using CA125 as a biomarker in women who present with such symptoms and help in early detection and analysis of complications related to menorrhagia and dysmenorrhea.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 12.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •Females belonging to menstrual age group who understand and give informed consent.
- •Diagnosed with Adenomyosis based on USG findings using MUSA’s criteria and having symptoms of dysmenorrhea or menorrhagia.
- •Patients with above symptoms who have been given CA125 test.
排除标准
- •Patient who have not consented for the study.
- •Patients diagnosed with gynecological malignancies.
结局指标
主要结局
VAS Score
时间窗: Baseline, 8 weeks
Pictorial Blood Loss Assessment Chart (PBAC)
时间窗: Baseline, 8 weeks
The association between CA 125 and Menorrhagia or Dysmenorrhea will be analysed and the impact of focal vs diffuse adenomyosis will be assessed.
时间窗: Baseline, 8 weeks
次要结局
- To study the factors affecting CA125.(To study diffuse vs focal type of adenomyosis and its relation with CA125)
研究者
Dr Sutanka Sujaini
Kasturba Hospital, Manipal