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临床试验/CTRI/2024/09/074183
CTRI/2024/09/074183已完成1 期

SENSITIVITY AND SPECIFICITY OF BACTERIAL VAGINOSIS RAPID TEST KIT IN DIAGNOSING BACTERIAL VAGINOSIS: A PROSPECTIVE OBSERVATIONAL STUDY

Dr Katta Sushma1 个研究点 分布在 1 个国家目标入组 285 人开始时间: 2024年10月2日最近更新:

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
285
试验地点
1
主要终点
By this study, if the rapid test kit is proven then this kit will be the more efficient and economical way to diagnose bacterial vaginosis and hence reducing the time duration of diagnosing and treatment

研究概览

简要总结

This is a prospective observational study.    All women of age  19  to 45 years of age with complaint of white discharge per vagina and willing to give written and informed consent will be included in the study.     A detailed history and examination will be conducted. Per speculum examination will be done and vaginal swab will be taken slowly and sent for analysis. Two samples will be taken, one  for BV Kit and the other sample is sent for grams staining.     Swab is transferred on to the test area of kit  and after 20 seconds under bright light compare the color of test strip with the color card.    If the result is between 5-9 then it is diagnosed as bacterial vaginosis.       The results of both the samples will be analyzed and results documented.

研究设计

研究类型
Interventional

入排标准

年龄范围
19.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • White discharge per vagina.

排除标准

  • Patients with bleeding per vagina along with white discharge per vagina.

结局指标

主要结局

By this study, if the rapid test kit is proven then this kit will be the more efficient and economical way to diagnose bacterial vaginosis and hence reducing the time duration of diagnosing and treatment

时间窗: 30 seconds

次要结局

  • Helps in rapid diagnosis of bacterial vaginosis infection(3 days)

研究者

发起方
Dr Katta Sushma
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Katta Sushma

Shri B.M.Patil medical college hospital and research Centre

研究点 (1)

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