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CTRI Number  CTRI/2024/04/065056 [Registered on: 02/04/2024] Trial Registered Prospectively
Last Modified On: 01/04/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Kannada Questionnaire for a Womans Intimate Problems. 
Scientific Title of Study   Adaptation and Translation of the Australian Pelvic Floor Questionnaire for Pregnant and Postpartum Kannada-Speaking Women in India: A Cross-Cultural Validation Study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Preeti Shankar Malapure  
Designation  Assistant Professor  
Affiliation  Shri B M Patil Medical College, Hospital and Research Centre  
Address  OPD NO.2, Department of Obstetrics and Gynaecology,Shri B M Patil Medical College,Hospital and Research Centre, BLDE(DU), Vijayapura
OPD No.2, Department of OBG,Shri B M Patil MC H & RC,Vijayapura 586101
Bijapur
KARNATAKA
586101
India 
Phone  9113945722  
Fax    
Email  preetimalapure1991@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Preeti Shankar Malapure  
Designation  Assistant Professor  
Affiliation  Shri B M Patil Medical College, Hospital and Research Centre  
Address  OPD NO.2, Department of Obstetrics and Gynaecology,Shri B M Patil Medical College,Hospital and Research Centre, BLDE(DU), Vijayapura


KARNATAKA
586101
India 
Phone  9113945722  
Fax    
Email  preetimalapure1991@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Preeti Shankar Malapure  
Designation  Assistant Professor  
Affiliation  Shri B M Patil Medical College, Hospital and Research Centre  
Address  OPD NO.2, Department of Obstetrics and Gynaecology,Shri B M Patil Medical College,Hospital and Research Centre, BLDE(DU), Vijayapura

Bijapur
KARNATAKA
586101
India 
Phone  9113945722  
Fax    
Email  preetimalapure1991@gmail.com  
 
Source of Monetary or Material Support  
Shri B M Patil Medical College Hospital and Research Centre BLDE (DU), Vijayapura, Karnataka, India,586101 
 
Primary Sponsor  
Name  Shri B M Patil Medical College,Hospital & RC 
Address  OPD NO.2,Department of OBG,Shri B M Patil Medical College,Hospital & RC,BLDE(DU),Vijayapura,Karnataka,586101 
Type of Sponsor  Research institution and hospital 
 
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 Preeti Shankar Malapure  Shri B M Patil Medical College,Hospital & Research Centre  OPD Room NO.2,Department of Obstetrics & Gynaecology,BLDE(DU),Solapur Road,Vijayapura,Karnataka,586101
Bijapur
KARNATAKA 
9113945722

preetimalapure1991@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SHRI B M PATIL MEDICAL COLLEGE,HOSPITAL & RESEARCH CENTRE,VIJAYAPURA,BLDE(Deemed To be University)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O269||Pregnancy related conditions, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  Pregnant women more than 19 years and more than 28 weeks period of gestation ,Post partum women upto 12 months of delivery and All participants should be fluent or literate in Kannada.
 
 
ExclusionCriteria 
Details  1.Urogenital malformations, or medications affecting bladder or bowel or sexual function .
2.Women who don’t wish to be included in the study
3.Non Kannada speaking women
4.Patients with psychiatric disorder
5.Clinically unstable patients
6.Malignancy or fractures of the pelvic area,
7.Patients with no cognitive ability to answer the questionnaire.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Validation of the translated questionnaire   3 months,1 year 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the content validity of the translated questionnaire by obtaining feedback from healthcare professionals, researchers, & pregnant & postpartum Kannada-speaking women.
 
16 weeks

 
To evaluate the psychometric properties of the adapted & translated questionnaire, including its reliability & validity, within the Kannada-speaking pregnant & pastpartum population.  20 weeks  
 
Target Sample Size   Total Sample Size="126"
Sample Size from India="126" 
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)   15/04/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Many women face the challenges of pelvic floor dysfunction, which manifest through symptoms such as urinary incontinence, urinary tract infections, fecal incontinence, flatulence, sexual problems, and pelvic organ prolapse. It’s noteworthy that pelvic floor dysfunction affects up to 25% of all women. These issues often emerge or worsen during and after pregnancy, burdening young women with silent struggles. Due to the stigma and cultural barriers surrounding these topics, they often refrain from seeking treatment. Early identification and management of these disorders are critical to prevent potential long-term complications.

The Australian pelvic floor questionnaire (APFQ) is an interviewer-administered tool designed to comprehensively assess pelvic floor health, encompassing bladder, bowel, and sexual function, as well as pelvic organ prolapse, severity, bothersomeness, and condition-specific quality of life. It’s a well-validated instrument and has been successfully translated into a few languages, including Swedish, Polish, Brazilian, Sinhala, Chinese, among others. These translations have expanded the reach of this assessment tool to women worldwide, breaking down cultural barriers that surround pelvic floor problems.

However, in India, no such translations are available, and Kannada, being the predominant language in the Vijayapura district, presents an opportunity for cultural adaptation and validation. Thus, our aim is to translate the APFQ into Kannada, ensuring it is culturally acceptable to the local pregnant and postpartum population, thereby enabling early identification and management of pelvic floor disorders.

 
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