| 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
|
|
|
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
|
|
|
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. |