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CTRI Number  CTRI/2025/12/099034 [Registered on: 15/12/2025] Trial Registered Prospectively
Last Modified On: 12/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Single Arm Study 
Public Title of Study   A clinical study to assess the improvement in breastfeeding practices among first time mothers upon implementing an educational video on correct latching during breastfeeding. 
Scientific Title of Study   Effectiveness of educational intervention using visual intervention tool on breastfeeding practices and LATCH score in postnatal mothers at a tertiary care hospital. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vanya Clemente 
Designation  MBBS Student 
Affiliation  Goa Medical College  
Address  Room No 10, Department of Obstetrics and Gynaecology, Goa Medical College, Bambolim.

North Goa
GOA
403202
India 
Phone  9284614372  
Fax    
Email  clementevanya@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ajit A Nagarsenkar 
Designation  Associate Professor 
Affiliation  Goa Medical College 
Address  Department of Obstetrics and Gynaecology, Goa Medical College, Bambolim, Goa

North Goa
GOA
403202
India 
Phone  9822168778  
Fax    
Email  tijanagarsenkar@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Ajit A Nagarsenkar 
Designation  Associate Professor 
Affiliation  Goa Medical College 
Address  Department of Obstetrics and Gynaecology, Goa Medical College, Bambolim, Goa

North Goa
GOA
403202
India 
Phone  9822168778  
Fax    
Email  tijanagarsenkar@yahoo.co.in  
 
Source of Monetary or Material Support  
Indian Council of Medical Research - Short Term Studentship (ICMR-STS) 
 
Primary Sponsor  
Name  Indian Council of Medical Research - Short Term Studentship (ICMR-STS) 
Address  V. Ramalingaswami Bhawan, P.O. Box No. 4911Ansari Nagar, New Delhi - 110029, India  
Type of Sponsor  Government funding agency 
 
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 Ajit A Nagarsenkar  Goa Medical College and Hospital   Room No 10, Department of Obstetrics and Gynaecology, Goa Medical College, Bambolim.
North Goa
GOA 		 9822168778

tijanagarsenkar@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Goa Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Intervention in primiparous breastfeeding mothers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  There will be no comparator agent used in this study 
Intervention  Visual Intervention Tool  Open source video uploaded by the Scottish Government on their YouTube channel taken from the Best Beginnings film “From Bump to Breastfeeding”. Duration of the video is 1 minute and there will be a 10 minute explanation of said video by the investigator. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  Primiparous singleton pregnancy mother-child dyads:
1) Women of age 18 years or older
2) Infants born at term (greater than or equal to 37 weeks of gestation)
3) Birth weight of infant greater than or equal to 2.5 Kg 
 
ExclusionCriteria 
Details  1) Mothers with acute puerperal illness, heart disease, cancer, nephritis, active or untreated tuberculosis, HIV or AIDS, active herpes breast lesions, severe malnutrition and acute breast complications such as cracked nipples and inverted nipples
2) Pre-term babies and term babies with acute illness, metabolic disorders, developmental disorders and those requiring NICU care 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Mean Latch Score  Baseline and protocol 48 hours post-intervention  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   Phase 4 
Date of First Enrollment (India)   05/01/2026 
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="3"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [clementevanya@gmail.com].

  6. For how long will this data be available start date provided 03-06-2030 and end date provided 06-06-2033?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This study is a Pre-post intervention study (Quasi-Experimental) that will assess the effectiveness of a visual tool based educational intervention, in the form of an animated video in improving breastfeeding practices in primiparous breastfeeding mothers. Mothers will be assessed using the LATCH scoring system designed by Jensen et al. It will also assess the proportion of mothers who wish to practice exclusive breastfeeding. It will be conducted in the Department of Obstetrics and Gynaecology at Goa Medical College. The primary outcome measure will be LATCH score at baseline and post-intervention.

 
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