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
|
|
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
|
|
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. |