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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  
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 
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  
Status 
Not Applicable 
 
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.

 

 
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