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CTRI Number  CTRI/2019/01/016820 [Registered on: 01/01/2019] Trial Registered Prospectively
Last Modified On: 23/05/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Utilization of reproductive health care services in Tribal Women of Rural Areas in Betul, Madhya Pradesh 
Scientific Title of Study   Reproductive Health Care Seeking Behaviour in Tribal Women of Rural Areas in Betul, Madhya Pradesh. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shubhangi Pandagre 
Designation  MPH 3rd semester student 
Affiliation  Prasanna School of Public Health 
Address  Prasanna School of Public Health Manipal Academy of Higher Education Manipal

Udupi
KARNATAKA
576104
India 
Phone  9503902291  
Fax    
Email  dr.shubhangipandagre@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shaikh Shah Hossain 
Designation  Associate Professor 
Affiliation  Prasanna School of Public Health 
Address  Prasanna School of Public Health Manipal Academy of Higher Education Manipal

Udupi
KARNATAKA
576104
India 
Phone  9810804242  
Fax    
Email  shah.manipal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Lalit Pawar  
Designation  Accountant 
Affiliation  Community Health Center  
Address  Community Health Center Multai Betul Road Multai

Betul
MADHYA PRADESH
460661
India 
Phone  9425659511  
Fax    
Email  lalitpawar85@gmail.com  
 
Source of Monetary or Material Support  
Self Sponsored 
 
Primary Sponsor  
Name  Dr Shubhangi Pandagre 
Address  Prasanna School of Public Health Manipal Academy of Higher Education Manipal 
Type of Sponsor  Other [Self Sponsor] 
 
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 Shubhangi Pandagre  Prasanna School of Public Health  Prasanna School of Public Health Manipal Academy of Higher Education Manipal
Udupi
KARNATAKA 		 9503902291

dr.shubhangipandagre@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Any tribal women who have given birth to the child in past 3 months 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Any women who have delivered in last 3 months.

Mothers from tribal population.  
 
ExclusionCriteria 
Details  Mothers with mental illness and disability. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Identify factors influencing reproductive health care seeking behaviour.   Last week of April 
 
Secondary Outcome  
Outcome  TimePoints 
Factors: Age, socio demographic factors, literacy, language barrier, socioeconomic factors, cultural practices, age at marriage, age at first conception, Autonomy of a woman.  Last week of April 
 
Target Sample Size   Total Sample Size="360"
Sample Size from India="360" 
Final Enrollment numbers achieved (Total)= "237"
Final Enrollment numbers achieved (India)="237" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/01/2019 
Date of Study Completion (India) 12/03/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="5"
Days="29" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This is an epidemiological (cross-sectional) study. with the objective to measure various patterns of reproductive care seeking in tribal women of Betul district, Madhya Pradesh. Determining the proximate driver influencing reproductive health care seeking behaviour in these tribal women. The data suggest that reproductive and child care is very poor among tribal population.Therefore, in order to understand factors affecting utilization of services, there is a need to asses reproductive health seeking behaviour among women belonging to scheduled tribes.  
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