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
|
|
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
|
|
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. |