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CTRI Number  CTRI/2018/08/015517 [Registered on: 29/08/2018] Trial Registered Prospectively
Last Modified On: 23/08/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   awareness of pregnant women about diet and its effect on Hemoglobin level  
Scientific Title of Study   Knowledge and practice of pregnant women about diet and its impact on Hemoglobin level in a tertiary care hospital. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Akshitha A 
Designation  Bsc.MLT Intern 
Affiliation  Medical laboratory technology 
Address  School of allied health sciences, Manipal Academy of Higher Education,Manipal
School of allied health sciences, Manipal Academy of Higher Education ,Manipal
Udupi
KARNATAKA
576104
India 
Phone  9535384587  
Fax    
Email  akshithaachu48@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Saritha Kamath U 
Designation  Asso. Professor 
Affiliation  Medical laboratory technology 
Address  School of allied health sciences,Manipal Academy of Higher Education, Manipal
School of allied health sciences,Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India 
Phone  9844344459  
Fax    
Email  saritha.kamath@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Akshitha A 
Designation  Bsc.MLT Intern 
Affiliation  Medical laboratory technology 
Address  School of allied health sciences,Manipal Academy of Higher Education, Manipal
School of allied health sciences, Manipal Academy of Higher Education ,Manipal
Udupi
KARNATAKA
576104
India 
Phone  9535384587  
Fax    
Email  akshithaachu48@gmail.com  
 
Source of Monetary or Material Support  
School of Allied Health Sciences, MAHE, Manipal, India 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [Nil] 
 
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 
Akshitha A  Kasturba Hospital Manipal   OBG department Manipal
Udupi
KARNATAKA 
9535384587

akshithaachu48@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  Pregnant women 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Naturally conceived pregnant women who is attending Kasturba Hospital Manipal, Manipal Academy of Higher Education, during 2nd or 3rd trimester with request for blood investigations ( Hematological parameters).

 
 
ExclusionCriteria 
Details  1. Conceived with assisted reproductive techniques 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
knowledge and practice of diet in pregnant women  at the time collecting questionaire 
 
Secondary Outcome     
Target Sample Size   Total Sample Size="189"
Sample Size from India="189" 
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)   01/09/2018 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Anemia during pregnancy effects both maternal and child health.Prevalence of anemia in during pregnancy is high. Anemia during pregnancy is one of the major causes for maternal mortality. Intake of healthy diet, iron and folic acid intake during pregnancy could have a profound influence on their haemoglobin levels.It is showed that socio demographic factors like education, income, parity, exposure to counselling having influence on anemia. The purpose of this study was to assess the knowledge and practice of pregnant women on diet regarding anemia,iron rich food  and also to assess the impact of these factors on haemoglobin level.Women who are pregnant are at a higher risk of developing anemia.  Anaemia during pregnancy can be a mild condition and easily treated if caught early on. However, it can become dangerous, to both the mother and the baby, if it goes untreated. Anaemia during pregnancy is considered severe when hemoglobin concentration is less than 7.0g /dL, moderate when hemoglobin concentration between 7.0-9.9g/dL and mild when HB concentration is between 10.0-11g/dl .The cause of anemia during pregnancy include nutritional deficiency of iron,folate and vitamin B12 and also parasitic infection.Anemia in pregnancy mainly due to poor nutritional intake, repeated infections and frequent pregnancies.It is also associated with socioeconomic conditions, lifestyle and health seeking behaviours across different cultures.Eating a healthy diet protects against anemia.Iron is found in meats, iron fortified breads ,cereals,Eggs,spinach and dried fruits.VitB12 is found in meat,fish ,shellfish,eggs and dairy products. High levels of folate are found in green leafy vegetables, beans, beef etc. Consuming the diet rich foods will be  helpful to  prevent anemia.Women who are vegetarians can replace animal foods with lentils ,beans and soy milk .Eating plenty of citrus fruit and avoiding tea and cover with or soon after meals ,may help the absorption of iron from the food and may help prevent anaemia in pregnancy.

 
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