| 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
|
|
|
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
|
|
|
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.
|