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CTRI Number  CTRI/2018/12/016490 [Registered on: 03/12/2018] Trial Registered Prospectively
Last Modified On: 03/12/2018
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Mixed Methods (Cross-sectional and qualitative) 
Study Design  Other 
Public Title of Study   Compliance to IFA tablet therapy among pregnant women in Delhi 
Scientific Title of Study   ADHERENCE TO IRON-FOLIC ACID IN PREGNANT WOMEN IN AN URBAN HEALTH CENTER IN DELHI, INDIA: A MIXED-METHODS STUDY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  M Meghachandra Singh 
Designation  Director Professor, Dept. of Community Medicine 
Affiliation  Maulana Azad Medical College 
Address  Dept. of Community Medicine Maulana Azad Medical College New Delhi

Central
DELHI
110002
India 
Phone  9968604248  
Fax    
Email  megharita1@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  M Meghachandra Singh 
Designation  Director Professor, Dept. of Community Medicine 
Affiliation  Maulana Azad Medical College 
Address  Dept. of Community Medicine Maulana Azad Medical College New Delhi


DELHI
110002
India 
Phone  9968604248  
Fax    
Email  megharita1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Saurav Basu 
Designation  Senior Resident, Dept. of Community Medicine 
Affiliation  Maulana Azad Medical College 
Address  Dept. of Community Medicine Maulana Azad Medical College New Delhi

Central
DELHI
110002
India 
Phone  8447527452  
Fax    
Email  saurav.basu1983@gmail.com  
 
Source of Monetary or Material Support  
Dept. of Community Medicine Maulana Azad Medical College, New Delhi 
 
Primary Sponsor  
Name  Dept of Community Medicine Maulana Azad Medical College 
Address  2 Bahadur Shah Zafar Marg New Delhi, 110002 
Type of Sponsor  Government medical college 
 
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 
M Meghachandra Singh  Maulana Azad Medical College, New Delhi  Room No. 362 Dept. of Community Medicine
Central
DELHI 
9968604248

megharita1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Maulana Azad Medical College & Associated Hospitals  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Adult pregnant women with ≥ 16 weeks amenorrhea without severe anemia 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Adult pregnant women with ≥ 16 weeks amenorrhea attending the antenatal clinic in Urban Health Center, Gokalpuri 
 
ExclusionCriteria 
Details  1. Severe anemia patients (Hb < 8)
2. Anemic women who are on parenteral iron therapy or received blood transfusion during pregnancy
3. Anemic women previously diagnosed with non-iron deficiency anemia
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Proportion of women adherent to iron-folic acid therapy  Time of enrollment 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="230"
Sample Size from India="230" 
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)   03/12/2018 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Anemia is a major public health challenge globally which affects over 1 billion people. The most common cause of anemia is iron deficiency (IDA) which can occur due to nutritional deficiency secondary to decreased iron intake, increased iron loss from the body and increased iron requirement. IDA is defined as individual hemoglobin levels that are 2 SDs below the distribution mean or >5% of a given population has hemoglobin levels that are 2 SD below the distribution mean in an otherwise normal population of individuals from same sex and age groups, living at the same altitude. Factors like dietary deficiency, iron inhibitors in diet, poor iron stores in childhood and adolescence, iron losses during post-partum hemorrhage, teenage pregnancy, repeated pregnancies with inadequate spacing and poor sanitary conditions increases the burden of iron deficiency anemia especially among women undergoing pregnancy in the developing world. Pregnancy is a physiological state characterized by increased iron demand which increases the risk of iron-deficiency anemia. According to the classification of World Health Organization (WHO), pregnant women with hemoglobin levels less than 11.0 g/dl in the first and third trimesters and less than 10.5 g/dl in the second trimester are considered anemic. A large scale cross-sectional survey, the Indian National Family Healthy Survey-4 found 58% of pregnant women in India are anemic. It is well-established that IDA is associated with multiple adverse outcomes for both mother and infant, including an increased risk of hemorrhage, sepsis, maternal mortality, perinatal mortality, and low birth weight. Furthermore, anemia  in pregnant women is  estimated  to  contribute  to  more  than  115,000  maternal  deaths  and  591,000 perinatal deaths globally per year. Anemia is considered as the underlying cause for 20–40 per cent of maternal deaths in India. India also contributes to 15% of the global burden of maternal deaths.

Current prevention and control strategies for IDA for women in India are focused upon iron folic acid supplementation beginning from childhood and continuing during pregnancy and lactation. Nevertheless, these strategies have been either ineffective or inadequate in controlling IDA in India. Moreover poor adherence to IFA is a major challenge in Indian health settings. Findings from the NFHS-4 reveal that only 52% women took 100 IFA pills during their pregnancy.

LACUNAE IN PREVIOUS STUDIES: There is a paucity of Indian studies which have assessed factors associated with poor IFA intake and perspectives on preventing anemia through a life-cycle programmatic intervention approach.

 
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