| 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
|
|
|
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
|
|
|
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. |