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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Healthy Human Volunteers |
|
Intervention / Comparator Agent
|
|
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 |
|
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. |