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CTRI Number  CTRI/2025/06/088236 [Registered on: 04/06/2025] Trial Registered Prospectively
Last Modified On: 03/06/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study of Knowledge, concepts and its implementations of breastfeeding among Lactating Mothers 
Scientific Title of Study   Knowledge, Implementations and concepts of breastfeeding Among Lactating Mothers 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shaishav Patel 
Designation  Assistant Professor, MD Pediatrics 
Affiliation  Ananya College of Medicine and Research 
Address  Room No.8, Department of Pediatrics, Adarsh Multispeciality Hospital, Ananya College of Medicine and Research, Kalol Institute and Research Center, Pratap Pura Village, Kalol, Gandhinagar, Gujarat 382721

Gandhinagar
GUJARAT
382721
India 
Phone  9428603871  
Fax    
Email  pshaishav246@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mukundkumar Patel 
Designation  Professor, MD Medicine 
Affiliation  Ananya College of Medicine and Research 
Address  Room No.6, Department of Medicine, Adarsh Multispeciality Hospital, Ananya College of Medicine and Research, Kalol Institute and Research Center, Pratap Pura Village, Kalol, Gandhinagar, Gujarat 382721

Gandhinagar
GUJARAT
382721
India 
Phone  09909013760  
Fax    
Email  mukundvp69@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mukundkumar Patel 
Designation  Professor, MD Medicine 
Affiliation  Ananya College of Medicine and Research 
Address  Room No.6, Department of Medicine, Adarsh Multispeciality Hospital, Ananya College of Medicine and Research, Kalol Institute and Research Center, Pratap Pura Village, Kalol, Gandhinagar, Gujarat 382721

Gandhinagar
GUJARAT
382721
India 
Phone  09909013760  
Fax    
Email  mukundvp69@gmail.com  
 
Source of Monetary or Material Support  
Ananya College of Medicine and Research 
 
Primary Sponsor  
Name  Dr Mukundkumar Patel 
Address  Ananya College of Medicine and Research, Adarsh Multispeciality Hospital, Kalol Institute and Research Center, Pratap Pura Village, Kalol, Gandhinagar, Gujarat 382721 
Type of Sponsor  Other [self] 
 
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 Shaishav Patel  Ananya College of Medicine and Research  Ananya College of Medicine and Research, Adarsh Multispeciality Hospital, Kalol Institute and Research Center, Pratap Pura Village, Kalol, Gandhinagar, Gujarat 382721
Gandhinagar
GUJARAT 		 9428603871

pshaishav246@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ananya Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Lactating Mothers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1.Lactating mothers with infants aged 0 to 24 months.
2.Willingness to provide informed consent.
 
 
ExclusionCriteria 
Details  1.Mothers with known medical contraindications to breastfeeding.
2.Infants with congenital anomalies affecting breastfeeding.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Identifies gaps in breastfeeding knowledge and practices.
2.Improved breastfeeding rates and practices.
3.Enhanced maternal and child health outcomes.
 		 over 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   01/07/2025 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   This study is cross sectional observational study about Breastfeeding Knowledge, Practices, and Misconceptions Among Lactating Mothers. Despite widespread breastfeeding promotion, gaps in knowledge and practices persist, leading to suboptimal breastfeeding rates. Understanding these gaps can inform targeted interventions and improve child health outcomes. Main Objectives of study are to assess knowledge regarding breastfeeding among lactating mothers, to evaluate breastfeeding practices and their implementation, to analyze the concepts and common misconceptions related to breastfeeding. Data collection will be in form of Structured questionnaires and interviews of Lactating Mothers. Statistical analysis will be done by Descriptive and inferential statistics using software. Questionnaires and informed consent are in local languages. This study will Identify gaps in breastfeeding knowledge and practices, Contribute to policy development and educational programs. Expected benefits of study are improved breastfeeding rates and practices and enhanced maternal and child health outcomes with minimal risk involving psychological discomfort. 
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