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CTRI Number  CTRI/2025/01/079319 [Registered on: 23/01/2025] Trial Registered Prospectively
Last Modified On: 23/01/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Understanding How Pregnant Working Women Strengthen Their Pelvic Muscles Awareness and Practices 
Scientific Title of Study   Knowledge Awareness and Practices of Pelvic Floor Strengthening Exercises among Pregnant working women A cross sectional survey 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Simran chauhan 
Designation  Student  
Affiliation  Galgotias university  
Address  Department of physiotherapy Galgotias university yamuna expy opposite Buddha international circuit sector 17A Greater Noida Uttar Pradesh

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  8929978738  
Fax    
Email  Simranchouhan382@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Simran chauhan 
Designation  Student  
Affiliation  Galgotias university  
Address  Department of physiotherapy Galgotias university yamuna expy opposite Buddha international circuit sector 17A Greater Noida Uttar Pradesh

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  8929978738  
Fax    
Email  Simranchouhan382@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Drsajjad Alam  
Designation  Professor  
Affiliation  Galgotias university  
Address  Department of physiotherapy Galgotias university yamuna expy opposite Buddha international circuit sector 17A Greater Noida Uttar Pradesh

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  9818879898  
Fax    
Email  sajjad.alam@galgotiasuniversity.edu.in  
 
Source of Monetary or Material Support  
Department of physiotherapy, Galgotias university yamuna expy, opposite Buddha international circuit, sector 17A Greater Noida Uttar Pradesh, Gautam Buddha Nagar UTTAR PRADESH 203201 India 
 
Primary Sponsor  
Name  Galgotias university  
Address  Department of physiotherapy, Galgotias university yamuna expy, opposite Buddha international circuit, sector 17A Greater Noida Uttar Pradesh, Gautam Buddha Nagar UTTAR PRADESH 203201 India 
Type of Sponsor  Research institution 
 
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 Sajjad Alam   Galgotias university   Department of physiotherapy, Galgotias university yamuna expy, opposite Buddha international circuit, sector 17A Greater Noida Uttar Pradesh, Gautam Buddha Nagar UTTAR PRADESH 203201 India
Gautam Buddha Nagar
UTTAR PRADESH 
09818879898

sajjad.alam@galgotiasuniversity.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Departmental research committee, Department of physiotherapy, school of allied health sciences, Galgotias University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O34||Maternal care for abnormality of pelvic organs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1.Pregnant Women: - both primigravida and multigravida.
2.Age: - 18 – 40 YEARS
3.Working
4.Living in Delhi NCR
5.Willingness to Participate 
 
ExclusionCriteria 
Details  1.Non- Pregnant Women
2.Women younger than 18 and older than 40 years
3.Unemployed. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.knowledge of pelvic floor muscles strengthening exercises.
2. Awareness of pelvic floor health.
3. Practice of pelvic floor muscle strengthening exercises. 
12 week 
 
Secondary Outcome  
Outcome  TimePoints 
1. Demographic Factors
2.sources of information
3.health history
4.perceived barriers to practice
5.health related quality of life  
12 weeks 
 
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)   10/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/03/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="5" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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  

The study focuses on the knowledge, awareness, and practices of pelvic floor muscle strengthening exercises among pregnant working women. The research was conducted by Prof. Dr. Sajjad Alam from the Faculty of Applied Health Sciences at Galgotias University. The study aims to understand the benefits and safety of mild to moderate exercise for expectant mothers and their developing fetuses. The study also highlights the importance of pelvic floor muscles (PFM) in supporting the bladder, uterus, and bowel, as well as managing faecal and urine incontinence. The study also highlights the importance of pelvic floor muscle exercises (PFMEs) in maintaining the strength of pelvic muscles, ensuring proper functioning of the bladder and other abdominal organs, and preventing urine incontinence. The Kegel exercises, first described by Arnold H. Kegel in 1948, are the most effective means of strengthening the pelvic floor muscles and managing pelvic floor dysfunctions. The study concludes that PFMEs can help prevent problems brought on by weak pelvic floor muscles and contribute to better urine retention and less urinary stress incontinence, particularly postpartum.


The study aims to identify knowledge,awareness and practice of pelvic floor muscles strengthening exercises among pregnant working women . Sample size is 300 and study need pregnant working women’s of age 18-40 years.


 
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