| CTRI Number |
CTRI/2024/11/077051 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
18/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Preventive
Process of Care Changes
Other (Specify) [Adherence to pelvic exercises, mode of delivery , perineal trauma ] |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating the Impact of a Mobile Application-Based Pelvic Exercise Intervention on Normal Vaginal Delivery Outcomes Among Antenatal Women |
|
Scientific Title of Study
|
Mobile Application-Based Intervention for the Impact of Pelvic Exercises on Normal Vaginal Delivery Among Antenatal Women. |
| Trial Acronym |
No |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr P S JAGATHISWARI |
| Designation |
Post graduate |
| Affiliation |
Saveetha Institute Of Medical And Technical Science |
| Address |
Room No 206, Department of OBG , Amaravathi Guest House , Saveetha Medical College And Hospitals, Thandalam Chennai-602105, Tamil Nadu, India
Chennai
TAMIL NADU
602105
India |
| Phone |
9841090002 |
| Fax |
|
| Email |
jagapurushoth7898@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrPSJAGATHISWARI |
| Designation |
Post graduate |
| Affiliation |
Saveetha Institute Of Medical And Technical Sciences, Saveetha University |
| Address |
Saveetha Medical College And Hospitals,Thandalam, Chennai, Tamil Nadu India, 602105.
Chennai
TAMIL NADU
602105
India |
| Phone |
9841090002 |
| Fax |
|
| Email |
jagapurushoth7898@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrPSJAGATHISWARI |
| Designation |
Post graduate |
| Affiliation |
|
| Address |
Saveetha Medical College And Hospitals, Thandalam, Chennai, Tamil Nadu India, 602105
Saveetha Institute of Medical And Technical Sciences, Saveetha University
Chennai
TAMIL NADU
602105
India |
| Phone |
9841090002 |
| Fax |
|
| Email |
jagapurushoth7898@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Institute Of Medical And Technical Sciences, Saveetha University, Saveetha nagar, Chennai, Tamil Nadu, India, 602105. |
|
|
Primary Sponsor
|
| Name |
Saveetha Institute Of Medical And Technical Sciences Saveetha University |
| Address |
Saveetha Medical College And Hospitals Thandalam Chennai Tamil Nadu India 602105 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| DrRajalekshmi |
Saveetha Institute of Medical And Technical Sciences, Saveetha University |
Labor ward -150, Department of Obstetrics and Gynaecology, Saveetha Medical College And Hospitals, Thandalam Chennai, Tamil Nadu, India, 602105
Chennai
TAMIL NADU |
9486668001
drrajivijay@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Institution Ethics Comittee |
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 |
Mobile Application name : EERUYIR
Case group name : EERUYIR |
Mobile Application Featuring Trimester-specific Pelvic Exercise Demonstration Videos Done By Certified Yoga Practitioner.
End User: Pregnant Women. Support Provider: Obstetrician
Resource Provided Through The App: 16 Videos -demonstrating The Steps Of Exercise, Breathing Patterns, Frequency Of Exercises, Benefits Of Exercises For Both Normal Vaginal Delivery, and patients are advised to do these exercises regularly on daily basis or 5 days a week till delivery.
Target: Promoting Normal Vaginal Delivery In Primi Gravida Patients With No Obstetric And Medical Contraindication To Vaginal Delivery, There In Evaluating The Impact Of The Pelvic Exercises On Normal Vaginal Delivery With The Ultimate Aim Of Improving Maternal And Neonatal Health While Minimizing The Requirement For Operative Interventions. |
| Comparator Agent |
NA |
Na |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Antenatal women aged 18-35 years.
• Primi gravida
•Singleton pregnancy.
•No contraindications for vaginal delivery.
•Willingness to participate in the study and adhere to the assigned intervention. |
|
| ExclusionCriteria |
| Details |
Women who are Multi gravida
•History of previous cesarean section or other pelvic floor surgeries.
•Known fetal anomalies or medical conditions complicating pregnancy.
•H/O any surgeries/ trauma to pelvis, cervix, limb, chest, lung, abdomen
•Short stature
•Autoimmune disorder.
Malpresentation
•Multiple pregnancy
•Cervical incompetence
•Bad obstetric history
•Psychiatric disorder |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of normal vaginal delivery. |
At the time of delivery( 4-5 months from mid trimester ) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adherence to pelvic exercises (measured using mobile application logs), mode of delivery (spontaneous vs. assisted), perineal trauma (episiotomy, tears), maternal satisfaction with childbirth experience (measured using validated scales), maternal mental health (measured using validated scales), feasibility of the app. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
30/11/2024 |
| 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="0"
Months="6"
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
|
Mobile application featuring trimester-specific pelvic exercise demonstration videos done by certified yoga practitioner. End user: Pregnant women. Support provider: Obstetrician Resource provided through the app: 16 videos -demonstrating the steps of exercise, breathing patterns, frequency of exercises,benefits of exercises for both normal vaginal delivery and impact on mental health. Target: Promoting normal vaginal delivery in primi gravida patients with no obstetric and medical contraindication to vaginal delivery, there in evaluating the impact of the pelvic exercises on normal vaginal delivery with the ultimate aim of improving maternal and neonatal health while minimizing the requirement for operative interventions. |