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临床试验/CTRI/2024/07/070299
CTRI/2024/07/070299已完成不适用

Evaluation of Abnormal Uterine Bleeding using International Endometrial Tumor Analysis Model

not applicable1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年7月17日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
to look at efficacy of using Ultrasound features of International Endometrial Tumour Analysis Guidelines in diagnosing abnormal endometrial pathologies (benign or malignant) in women with abnormal uterine bleeding

研究概览

简要总结

This is a prospective study design, where we will assess women with Abnormal uterine bleeding by firstly taking their history, doing a TVS (transvaginal ultrasound) to look for the headings as mentioned under IETA Guidelines( endometrial thickness,echogenicity,vascularity ,EM junction, bright edge, intracavitary fluid, color doppler, endometrial midline appearence) and score accordingly. If there is a high score of 6 or more,we will be taking a biopsy and corelating with its histopathology findings after 2 weeks for accuracy of diagnosis. We will initiate the study only after receiving the approval IEC. Based on the existing literature on use of IETA guidelines in Ultrasound to assess Abnormal uterine bleeding-a proforma will be made and the study will be carried out

研究设计

研究类型
Observational

入排标准

年龄范围
30.00 Year(s) 至 75.00 Year(s)(—)
性别
Female

入选标准

  • premenopausal women presenting with abnormal uterine bleeding Postmenopausal bleeding women consenting to be a part of this study.

排除标准

  • 1.) women under 30 years and above 75 years of age 2.) women presenting with features of leiomyoma 3.) women not consenting to be a part of the study.

结局指标

主要结局

to look at efficacy of using Ultrasound features of International Endometrial Tumour Analysis Guidelines in diagnosing abnormal endometrial pathologies (benign or malignant) in women with abnormal uterine bleeding

时间窗: 6-8 weeks, 2 months

次要结局

  • to reduce time taken for diagnosis for any endometrial pathology using USG features(6-8 weeks, 2 months)

研究者

申办方类型
Other [not applicable]
责任方
Principal Investigator
主要研究者

Dr Diya Ghoshal

Department of Obsteterics and gynaecology, Kasturba Medical College, MAHE

研究点 (1)

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