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CTRI Number  CTRI/2025/07/090002 [Registered on: 02/07/2025] Trial Registered Prospectively
Last Modified On: 01/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Other 
Public Title of Study   A clinical trail in married/sexually active females to compare efficacy of self collected vaginal samples versus physician collected samples using cotton swab in diagnosing vaginal infections  
Scientific Title of Study   Efficacy of self collected versus physician collected vaginal samples in infective vaginitis 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anusha V 
Designation  Postgraduate OBG 
Affiliation  Karnataka Institute of medical Sciences 
Address  Room no 4 out patient Department,ground floor,Department of OBG Karnataka Institute of Medical sciences,Vidya nagar,Hubli

Dharwad
KARNATAKA
580021
India 
Phone  9740768569  
Fax    
Email  anushavenkateshthesis49@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Yogendrakumar M Kabadi  
Designation  Associate Professor Department of OBG 
Affiliation  Karnataka Institute of medical Sciences 
Address  Room no 2,1st floor,Department of OBG,Karnataka Institute of Medical sciences ,Vidyanagar, Hubli

Dharwad
KARNATAKA
580021
India 
Phone  9448210579  
Fax    
Email  omkabadi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anusha V 
Designation  Postgraduate OBG 
Affiliation  Karnataka Institute of medical Sciences 
Address  Room no 4,out Patient department,ground floor ,Department of OBG Karnataka Institute of Medical sciences,Vidya nagar,Hubli

Dharwad
KARNATAKA
580021
India 
Phone  9740768569  
Fax    
Email  anushavenkateshthesis49@gmail.com  
 
Source of Monetary or Material Support  
Karnataka Institute of Medical sciences Hubli 
 
Primary Sponsor  
Name  Karnataka Institute of Medical sciences Hubli 
Address  Karnataka Institute of Medical sciences Vidyanagar Hubli 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anusha V  Karnataka Institute of Medical Sciences  Room no 4,groundfloor Department of Obstetrics and Gynecology Karnataka Institute of Medical Sciences Hubli
Dharwad
KARNATAKA 
9740768569

anushavenkateshthesis49@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Karnataka Institute of Medical Sciences Hubli Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A590||Urogenital trichomoniasis, (2) ICD-10 Condition: B373||Candidiasis of vulva and vagina, (3) ICD-10 Condition: B968||Other specified bacterial agents as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Patient taking self vaginal samples using cotton swab  vaginal samples taken by patient herself using cotton swab  
Comparator Agent  Physician taking vaginal sample using cotton swab from the same patient  Physician taking vaginal samples using speculum and cotton swab from the same patient to compare with patients self taken vaginal swab 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  Sexually active/married women aged 16-65 years with symptomatic vaginal discharge,vulval irritation, genital pain,and an offensive genital smell.  
 
ExclusionCriteria 
Details  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  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
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  24 hours to 48 hours 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="170"
Sample Size from India="170" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/07/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

 
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