| CTRI Number |
CTRI/2025/07/090501 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
19/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding What New Mothers Know and Feel About Urine Leakage After Childbirth at Tertiary Care Hospital in Wanadongri Hingna Region
|
|
Scientific Title of Study
|
Urinary Incontinence Awareness and Attitude Amongst Inpatient Post-Partum Women at Tertiary Care Hospital in Wanadongri Hingna Region
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Utkarsha Mangulkar |
| Designation |
Postgraduate student |
| Affiliation |
Datta Meghe College Of Physiotherapy Nagpur |
| Address |
Department of Community Physiotherapy, Datta Meghe College Of Physiotherapy, Shri Dattaji Meghe Polytechnic Campus, Wanadongri, Hingna Road, Nagpur Maharashtra 441110 India
Nagpur MAHARASHTRA 441110 India |
| Phone |
7083040729 |
| Fax |
|
| Email |
utkarsha.r.mangulkar@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Milind Kahile |
| Designation |
Professor |
| Affiliation |
Datta Meghe College Of Physiotherapy Nagpur |
| Address |
Department of Community Physiotherapy, Datta Meghe College Of Physiotherapy, Shri Dattaji Meghe Polytechnic Campus, Wanadongri, Hingna Road, Nagpur Maharashtra 441110 India
Nagpur MAHARASHTRA 441110 India |
| Phone |
8698715695 |
| Fax |
|
| Email |
milind.sportsphysio@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Utkarsha Mangulkar |
| Designation |
Postgraduate student |
| Affiliation |
Datta Meghe College Of Physiotherapy Nagpur |
| Address |
Department of Community Physiotherapy, Datta Meghe College Of Physiotherapy, Shri Dattaji Meghe Polytechnic Campus, Wanadongri, Hingna Road, Nagpur Maharashtra 441110 India
Nagpur MAHARASHTRA 441110 India |
| Phone |
7083040729 |
| Fax |
|
| Email |
utkarsha.r.mangulkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe College Of Physiotherapy, Wanadongri, Hingna Road, Nagpur Maharashtra 441110 India |
|
|
Primary Sponsor
|
| Name |
Datta Meghe College Of Physiotherapy, Nagpur |
| Address |
Shree Datta Meghe polytechnic campus,Wanadongri, Hingna Road, Nagpur Maharashtra 441110 India |
| 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 |
| Utkarsha Mangulkar |
Mother and Child Care Hospital Hingna |
gynecology unit, gynecology ward no 32,wanadongri hingna road Nagpur Maharashtra, 441110 India. Nagpur MAHARASHTRA |
7083040729
utkarsha.r.mangulkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Ayurved, Physiotherapy, Nursing(APN) Colleges Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P969||Condition originating in the perinatal period, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1 Postpartum women admitted to the tertiary care hospital
2 Willing to participate and provide informed consent
|
|
| ExclusionCriteria |
| Details |
1 Women with pre-existing neurological or urological conditions affecting bladder control
2 Women with communication barriers (speech and hearing impairment) or cognitive impairments affecting survey participation
3 Those unwilling to participate
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| URINAS SCALE |
1. day 1 of assessment
2. on the day of discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="300" Sample Size from India="300"
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)
|
18/08/2025 |
| 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="0" 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
|
Ethical clearance is given from the ethical committee prior to the commencement of study. Participants shall be selected on the basis of eligibility criteria mentioned earlier. A brief demographic data will be obtained and a written consent will be taken from all the included participants. Participants will be briefed about the study. There will be 300 number of participants. Eligible postpartum women will be approached in the maternity and postpartum wards, and those meeting the inclusion criteria will be included to participate. After obtaining informed consent, data will be collected using a structured and validated questionnaire, which may be self-administered or interviewer-assisted, depending on the participant’s preference and literacy level. The questionnaire will include sections on demographic and obstetric details, awareness of urinary incontinence and attitudes toward the condition. The questionnaire will be administered in the local language to ensure better comprehension. Data collection will be conducted in a private and comfortable setting to encourage honest responses, and confidentiality will be maintained throughout the process. |