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临床试验/CTRI/2025/07/090002
CTRI/2025/07/090002尚未招募不适用

Efficacy of self collected versus physician collected vaginal samples in infective vaginitis

Karnataka Institute of Medical sciences Hubli1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2025年7月14日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
170
试验地点
1
主要终点
self-collected swabs can approximate physician collected swabs with a high degree of reliability. Therefore, self-collected vaginal swabs are a viable and accurate method for diagnosing vaginal infections

研究概览

简要总结

This study aims to evaluate the efficacy of self-collected versus physician-collected vaginal samples using cotton swabs in diagnosing infective vaginitis among women attending the gynecology outpatient department  at KIMS Hospital, Hubballi. The primary objective is to compare the diagnostic outcomes of both sampling methods. Secondary objectives include identifying additional clinical findings through speculum examination that might be missed during self-sampling, assessing the acceptability of self-sampling among patients, and exploring its potential benefits in diagnosing vaginal infections, particularly in primary care and low-resource settings.

Married or sexually active women presenting with complaints of vaginal discharge are enrolled in the study. Participants are guided to collect low vaginal swabs themselves by standing with one leg elevated, separating the labial folds, and inserting three swabs marked at 8 cm into the vagina. The swabs are twisted thrice in either direction, left in place for 20 seconds, then removed and placed in a sterile tube. Following this, a clinician collects a high vaginal swab under a speculum examination using gloved hands. All samples are properly indexed, and the microbiologist analyzing them is blinded to the source of collection. The collected samples undergo Gram staining, whiff test, wet mount, and hanging drop examination to detect infections such as bacterial vaginosis, Candida, and Trichomonas vaginalis.

研究设计

研究类型
Interventional
分配方式
Na
盲法
Investigator Blinded

入排标准

年龄范围
16.00 Year(s) 至 65.00 Year(s)(—)
性别
Female

入选标准

  • Sexually active/married women aged 16-65 years with symptomatic vaginal discharge,vulval irritation, genital pain,and an offensive genital smell.

排除标准

  • a) Patients with history of antibiotic use or vaginal medication in the previous 14 days b) History of recent vaginal douching with significant vaginal bleeding or spotting c) Confirmed sexually transmitted infections.
  • d) Pregnancy and upto 6 weeks of postpartum e) Patients not willing and not compliant.

结局指标

主要结局

self-collected swabs can approximate physician collected swabs with a high degree of reliability. Therefore, self-collected vaginal swabs are a viable and accurate method for diagnosing vaginal infections

时间窗: 24 hours to 48 hours

次要结局

未报告次要终点

研究者

发起方
Karnataka Institute of Medical sciences Hubli
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Anusha V

Karnataka Institute of medical Sciences

研究点 (1)

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