| CTRI Number |
CTRI/2025/11/098135 [Registered on: 27/11/2025] Trial Registered Prospectively |
| Last Modified On: |
26/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the non invasive tests to know the healthy status of the baby in the womb with or without the sound and vibration |
|
Scientific Title of Study
|
Comparison of Labour Admission Test With And Without Vibroacoustic Stimulation Test |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrAjay Sood |
| Designation |
Professor |
| Affiliation |
DR. RAJENDRA PRASAD GOVERNMENT MEDICAL COLLEGE KANGRA AT TANDA HP |
| Address |
Prof Department of Obstetrics
and Gynecology Dr RPGMC Kangra at
Tanda Himachal Pradesh
Kangra
HIMACHAL PRADESH
17602
India |
| Phone |
9816021100 |
| Fax |
|
| Email |
Ajayshalu95@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Sood |
| Designation |
Professor |
| Affiliation |
|
| Address |
Third Floor Department of Obstetrics
and Gynecology Tanda Medical College
Kangra
HIMACHAL PRADESH
176002
India |
| Phone |
9816021100 |
| Fax |
|
| Email |
Ajayshalu95@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay Sood |
| Designation |
Professor |
| Affiliation |
|
| Address |
Department of Obstetrics
and Gynecology Tanda Medical College Kangra
Kangra
HIMACHAL PRADESH
176002
India |
| Phone |
9816021100 |
| Fax |
|
| Email |
Ajayshalu95@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Dr Rajendra Prasad Government Medical College Kangra at Tanda |
|
|
Primary Sponsor
|
| Name |
Dr Rajender Prasad Goverment Medical College Kangra at Tanda |
| Address |
Tanda Medical College Tanda Hospital Road Pushp Vihar Colony Kangra Sadarpur Himachal Pradesh 176002 |
| Type of Sponsor |
Government 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 |
| Dr Shikha Bharmouria |
Dr Rajendra Prasad Government Medical College Tanda |
Room No 303 Third Floor Indoor Unit Tanda Hospital Rd Pushp Vihar Colony Kangra Sadarpur Himachal Pradesh 176002
Kangra
HIMACHAL PRADESH |
08826473262
s.bharmouria42@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC of Dr RPGMC Tanda |
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
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Singleton pregnancy with cephalic presentation.
2.Period of gestation of more than or equal to 37 weeks.
3.Patient in Labour.
4.Cervical Dilatation of less than or equal to 4 cm.
|
|
| ExclusionCriteria |
| Details |
1.Malpresentation.
2.Absence of true labour pains.
3.Cervical dilatation of more than 4 cm.
4. Patient does not Deliver within 24 hrs.
|
|
|
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 |
| Comparison of the Labour Admission test with and without Vibroacoustic stimulation Test |
Not Applied |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. to predict mode of delivery
2.to predict neonatal outcome
|
|
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
19/12/2025 |
| 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
|
Ensuring the safety of mothers and babies during labour is vital but over 2 million stillbirths happen yearly worldwide many preventable with proper monitoring The biggest cause is intrapartum asphyxia where pressure during labour reduces oxygen to the baby Continuous electronic foetal monitoring CTG helps detect foetal distress early guiding timely care to minimize risks
The Vibroacoustic Stimulation Test VAS adds another layer by using sound and vibration to check the babys wellbeing when CTG results are unclear This study plans to use both CTG and VAS to better predict neonatal outcomes aiming to reduce NICU admissions deaths and complications something not yet done at this institute |