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CTRI Number  CTRI/2022/02/039928 [Registered on: 02/02/2022] Trial Registered Prospectively
Last Modified On: 11/05/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To know the knowledge and practices of mothers about lack of blood during pregnancy and how to avoid it in Rangjuli block, Goalpara, Assam 
Scientific Title of Study   Assessment of knowledge and practices of mothers regarding anemia and its prevention during pregnancy in Rangjuli block, Goalpara, Assam 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Daisy Daimary 
Designation  BDS, Postgraduate student (MPH)  
Affiliation  Prasanna School of Public Health 
Address  Department of Health Policy, room no-61, PSPH, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  8822378848  
Fax    
Email  daisy.daimary@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Navya Vyas 
Designation  BHMS, MPH, Assistant Professor 
Affiliation  Prasanna School of Public Health 
Address  Department of Health Policy, room no-62, PSPH, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9538126121  
Fax    
Email  navya.vyas@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Navya Vyas 
Designation  BHMS, MPH, Assistant Professor 
Affiliation  Prasanna School of Public Health 
Address  Department of Health Policy, room no-62, PSPH, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9538126121  
Fax    
Email  navya.vyas@manipal.edu  
 
Source of Monetary or Material Support  
Prasanna School of Public Health, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka-576104  
 
Primary Sponsor  
Name  Dudhnoi ICDS Project 
Address  Office of the Child Development Project Officer, Rangjuli, Goalpara, Assam 
Type of Sponsor  Other [Government Programme] 
 
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 Navya Vyas  Anganwadi Centres  Office of the Child Development Project Officer, Dudhnoi ICDS Project, Rangjuli
Goalpara
ASSAM 
9538126121

navya.vyas@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics committee-2   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Human Volunteers 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  49.00 Year(s)
Gender  Female 
Details  All mothers aged more than 18 years and who are in their postpartum period  
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
This study will provide insight into the knowledge and
practices regarding prevention of anemia among postnatal women of
Rangjuli block. 
8 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
The study will help in assessing the gaps, if any, between the
knowledge and practices to prevent anemia and to identify the factors that
are influencing the practices of those postnatal women. 
12 weeks 
 
Target Sample Size   Total Sample Size="426"
Sample Size from India="426" 
Final Enrollment numbers achieved (Total)= "304"
Final Enrollment numbers achieved (India)="304" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/02/2022 
Date of Study Completion (India) 31/03/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="23" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Anemia during pregnancy and postpartum period is a major global health problem with the highest prevalence in developing countries. In Assam, hemorrhage (21.3%), pregnancy induced hypertension (17.3%) and sepsis (10%) were the major cause of death among direct causes whereas anemia (28.7%) was the major indirect cause of maternal death. The study will be conducted in Goalpara district of Assam which is a backward district in terms of health, nutrition, education, basic infrastructure like rural road connectivity and access to potable water. In rural areas of developing countries, anemia in pregnancy is generally associated with infections and nutritional deficiencies. The prevalence of iron deficiency anemia among pregnant women is high in Assam which highlights that this is an important public health problem. So preventing anemia or treating it during the antenatal period is essential.
     The objectives of the study is to assess the knowledge and practices of mothers regarding anemia and its prevention during pregnancy and to determine the factors influencing the knowledge and practices of mothers towards prevention of anemia during pregnancy.
     Sample size is calculated using formula for single proportion with 5% marginal error and 95% confidence interval (CI) i.e. n = Z 2 P(1-P)/d 2. where, n= sample size Z= statistic for a level of confidence (1.96), P= expected prevalence or proportion, d= precision (0.05) Previous study conducted in Puducherry shows the prevalence of knowledge of anemia among pregnant women is 52.23% and by considering a non-response rate of 10%, the final sample size calculated is 426. A validated questionnaire will be used. The questionnaire will consist of socio-demographic characteristics, knowledge about anemia and practices to prevent anemia during pregnancy.
     This study will provide insight into the knowledge and practices regarding prevention of anemia among postnatal women of Rangjuli block. It will help in assessing the gaps, if any, between the knowledge and practices to prevent anemia and to identify the factors that are influencing the practices of those postnatal women. Addressing these gaps and factors will help in providing necessary suggestions and recommendations to control and reduce anemia related health problems in future at the community level. 
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