| CTRI Number |
CTRI/2025/04/085089 [Registered on: 17/04/2025] Trial Registered Prospectively |
| Last Modified On: |
24/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
How Kegel Exercises in Late Pregnancy Affect Mothers: A Clinical Study |
|
Scientific Title of Study
|
A Randomized Clinical Trial to Assess the Impact of Kegel Exercise in the Third Trimester of Pregnancy on Maternal Outcomes. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Farha Usmani |
| Designation |
PhD Scholar |
| Affiliation |
Jamia Hamdard |
| Address |
RUFAIDA COLLEGE OF NURSING, JAMIA HAMDARD Hamdard Nagar, New Delhi- 110062
New Delhi
DELHI
110062
India |
| Phone |
8826884450 |
| Fax |
|
| Email |
farha786usmani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF (DR) MANJU CHHUGANI |
| Designation |
PROFESSOR |
| Affiliation |
Jamia Hamdard |
| Address |
Hamdard Nagar, New Delhi- 110062
New Delhi
DELHI
110062
India |
| Phone |
9818141401 |
| Fax |
|
| Email |
MANJUCHHUGANI@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
Farha Usmani |
| Designation |
PhD Scholar |
| Affiliation |
Jamia Hamdard |
| Address |
RUFAIDA COLLEGE OF NURSING, JAMIA HAMDARD, Hamdard Nagar, New Delhi- 110062
New Delhi
DELHI
110062
India |
| Phone |
8826884450 |
| Fax |
|
| Email |
farha786usmani@gmail.com |
|
|
Source of Monetary or Material Support
|
| GS SUPER SPECIALITY HOSPITAL |
|
|
Primary Sponsor
|
| Name |
RUFAIDA COLLEGE OF NURSING |
| Address |
JAMIA HAMDARD, HAMDARD NAGAR 110062 |
| Type of Sponsor |
Other [phd research] |
|
|
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 Rupali Sharma |
GS Super Specialty Hospital |
OBG DEPARTMENT, ROOM NO 74, 75 FIRST FLOOR
Ghaziabad
UTTAR PRADESH |
9690431619
rupalinautiyal@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| GS MEDICAL COLLEGE AND HOSPITAL |
No Objection Certificate |
| Jamia Hamdard Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kegel exercise |
Kegel exercise training will be provided to pregnant mothers From 26th week till 36th week of pregnancy and training of kegel exercise will be provided on 26 th week and a informational video will be provided through whatsapp
frequency- 3 times a day
duration- 10 week |
| Comparator Agent |
Routine Antenatal Care |
Control Group will get the routine antental care through the OPD |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women at 26 of gestation.
Pregnant women who are willing to maintain contact via mobile phone during research study.
Pregnant women who are Primipara and second gravida with previous normal vaginal delivery.
Singleton pregnancy.
|
|
| ExclusionCriteria |
| Details |
Pregnant women with high-risk pregnancy as per Pradhan Mantri Surakshit Matritva Abhiyan |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
pelvic floor muscle strength
urinary incontinence |
10 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| maternal outcome i.e normal vaginal delivery, perineal tear rate, episiotomy rate |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "110"
Final Enrollment numbers achieved (India)="110" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/04/2025 |
| Date of Study Completion (India) |
30/06/2025 |
| Date of First Enrollment (Global) |
21/04/2025 |
| Date of Study Completion (Global) |
30/06/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This randomized clinical trial (RCT) aims to evaluate the effectiveness of Kegel exercises during the third trimester of pregnancy in improving pelvic floor muscle strength, reducing severity of urinary incontinence, and enhancing maternal outcomes. Pregnant women in their third trimester will be randomly assigned to an intervention or control group. The intervention group will perform Kegel exercises three times a day. Outcomes will be assessed using a perineometer for PFM strength, the International Urinary Incontinence Questionnaire for urinary incontinence, and medical records for maternal outcomes (perineal tear, episiotomy, and mode of delivery).
The findings of this study will contribute to evidence-based recommendations for antenatal care, promoting safe and natural childbirth while reducing maternal complications. |