APPLICATION FOR IRB APPROVAL OF OBSERVATIONAL (CASE-CONTROL / COHORT/ CROSS-SECTIONAL) STUDIES
CHRISTIAN MEDICAL COLLEGE, VELLORE
(Please complete Sections I to III and submit with all supporting documents) SECTION I
Fluid Research Funding/External Funding (delete as appropriate)
If for external funding, please provide name of funding agency and the application for submission in the funding agency’s format, in addition to this application.
1. Title of Research : Prevalence of anaemia in pregnant women at booking visit
2. Title of Study (for lay public): Detecting low haemoglobin(BLOOD) levels in pregnant women at their first visit to CMCH, Vellore.
3. Acronym if any : PAP in Obstetrics (Prevalence of Anaemia in Pregnancy) 4. Unique Protocol ID, if any : None
5. Name of the Principal Investigator: Dr.Madhu Priya N 6. Designation / Department / Unit / of Principal Investigator: PG Registrar, MD O&G, Obstetrics and Gynaecology Unit IV, Christian Medical College, Vellore, 632004.
Employment Number: 31255
Address for communication (including telephone and fax numbers and email id):
Dr.Madhu Priya N,
Obstetrics and Gynaecology Unit IV,
Christian Medical College, Vellore, 632004.
Telephone No : 0416 228 6185,9443203774 E mail address : madhusri@cmcvellore.ac.in If Post Graduate Registrar / Fellowship:
Enrollment date of PG Course: 06/2013 Completion date of PG Course: 04/2015
6. Name of Guide (for Post-Graduate Registrar / Fellowship):Dr.Ruby Jose Employment Number: 11484
Address for communication (including telephone and fax numbers and email id):
Head of Unit IV,
Dept.of Obstetrics and Gynaecology, Christian Medical College,
Vellore,632004.
Telephone No : 0416 228 6185,0416 228 2180 ,9994747188 E mail address : rubyjose1@gmail.com
7. Name and Designation of Co-Investigator(s), Employment Number and Address : 1. Dr.Reeta Vijaya Selvi,
Employment Number : 50600 Assistant Professor,Unit IV, Christian Medical College, Vellore,632004.
Telephone No : 04162286185,9443766551 E mail address : reetavijayaselvi@gmail.com
2. Dr.Jeyaseelan,
Employment Number : 3031 Professor,
Dept.of Bio ststistics, Christian Medical College, Vellore,632004.
Telephone No : 04162282703,9443178432
E mail address : ljey@hotmail.com , ljey@cmcvellore.ac.in
7. Department of Institution where the research will be carried out Dept.of Obstetrics and Gynaecology,
Christian Medical College, Vellore,632004.
8. Names and addresses of other institutions where research will be carried out Nil
9. Duration of the Scheme.
3 months
10. Source/s of Monetary or Material Support Internal - Fluid /Major Research Grant : Nil
External : Nil
Departmental fund : Nil
11. Objectives and aims of study (including any hypotheses)
Objective : To find out the prevalence of anaemia in Obstetric OPD patients during their first antenatal visit to CMCH
Aims of the study :
1. This study aims at finding out the prevalence of anaemia and correlate with risk factors for its occurrence
2. Make recommendations for prevention and correction of anaemia in pregnant women
12. Summary of the proposed research scheme (250 words)
In India, anaemia is still the most common preventable cause for 20% of direct causes of mortality and for 20% of indirect causes of mortality in pregnant women. WHO has estimated the prevalence of anemia in pregnant women in developed and developing countries, and that is 14% in developed and 51% in developing countries. About one- third of the global population (over 2 billion) are anemic. Incidence of anemia in South Asian countries is the highest in the world. WHO estimates that even among the South Asian countries, India had the highest prevalence of anemia. Current knowledge (Source: WHO Global Database on Anaemia 1993-2005 and National Family Health Survey- NFHS III) indicates that iron deficiency anaemia in pregnancy is a risk factor for preterm delivery and subsequent low birth weight and possibly for inferior neonatal health. In World Health Organization / World Bank rankings, iron deficiency anaemia is the third leading cause of disability-adjusted lifeyears lost for females aged 15- 44 years.
Margaret Balfour was credited as the first to draw the attention of anaemia in pregnancy in India. In view of its public health importance, the Government of India sponsored National Nutritional Anemia Prophylaxis Programme (NNAP) during 4th Five Year Plan in 1970 with the aim to reduce the prevalence of anaemia to 25%.ICDS Projects are engaged in implementation of this programme. According to NHFS III the prevalence of anaemia has increased from 52.0(NHFS II)to 57.9 % and there has been
no decline in anaemia over the last 3 decades. So this study is planned to know the current status of anemia in pregnant women who are attending antenatal clinic in CMCH, urban Tamil Nadu.
In this study, all eligible pregnant women who are booked for the first time in the obstetric OPD will be requested to give a blood sample for haemoglobin estimation.
Demographic and other details of the pregnancy, education, fianancial status, diet, nutrition and other relevant risk factors for anaemia will be collected using a proforma.
The prevalence of anaemia, gestational age, parity and other demographic variables will be analysed by statistical tests.
13.Present Knowledge and relevant bibliography (Is there a justification for this study based on a detailed literature review or other sources of evidence? Please provide details)
Anaemia, defined as haemoglobin concentration less than 11.0gms% in pregnant women (WHO) is a widespread public health problem with major consequences for human health as well as social and economic development. Anaemia is the world’s second leading cause of disability and thus one of the most serious global public health problems. In India, Overall the prevalence varies from 68.8% to 96.8% during pregnancy. India became the first country to introduce the NNAP to prevent anemia among pregnant women,but has not made much improvement. NNAP was initiated in 1970 during the fourth 5-year health plan with the aim of reducing the prevalence of anemia to 25%. The Governmentof India recommends a minimum dose of total 100 iron and folic acid tablets to be prescribed during pregnancy.
Public health program of distribution of the iron tablets to the pregnant women and preschool children is in operation in India as part of Maternal and Child Health (MCH) services. However, high prevalence of anemia among pregnant women persists despite the availability of this effective, low-cost intervention for prevention and treatment. The major barriers to the efforts put in place for the prevention of anemia during pregnancy can well be the sociodemographic factors associated with anemia in pregnancy. Therefore details about these risk factors can be used to formulate a multipronged strategy to attack this important public health problem.
The last study done in CMC was in 2000, from RUSHA and was published in The National Medical Journal of India in 2000. According to this study the prevalence of maternal anaemia was 69.3%. After this study measures were instituted, and the effects of these measures need to be studied. In addition, economic conditions have improved, antenatal care is widespread and this is expected to decrease the anaemia in pregnant women.
1.Indian J MedRes 130, November 2009,K.kalaivani
Prevalence & consequences of anaemia in pregnancy Department of Reproductive Biomedicine, National Institute of Health & Family Welfare, New Delhi, India
2.Indian J Med Res 124, August 2006 Prevalence of anaemia in pregnant & lactating women in India
K.N. Agarwal*, D.K. Agarwal*, A. Sharma, K. Sharma, K. Prasad, M.C. Kalita, N. KhetarpaulA.C.
Kapoor, L. Vijayalekshmi, A.K. Govilla, S.M. Panda & P. Kumari
*Healthcare & Research Association for Adolescents Noida, & Nutrition Foundation of India,New Delhi, India
3 .Indian Journal of Applied Basic Medical Sciences Year 2010 Vol 12B,Issue 15.
4. JIMSA October - December 2010 Vol. 23 No. 4 253 Anemia in Pregnancy.
J.B.Sharma, Meenakshi Shankar Department of Obstetrics & Gyneocology, All India Institute of Medical Science, Ansari Nagar, New Delhi, India
5. Prevalence of anaemia among antenatal women in a tertiary care hospital, South India K. S.
Saraswathi, Farhana Aljabri and R. Shyamala
Department of Obstetrics and Gynaecology, Shadan Institute of Medical Sciences and Post Graduate Research Centre, Hyderabad, India
Department of Microbiology, Bhaskar Medical College, Yenkapally Village, Moinabad Mandal, Rangareddy District, India
6.Asian Journal of Medical Sciences Volume-5(2014)
Prevalence of Anaemia among Pregnant Women of Rural Community in Vizianagaram, North Coastal Andhra Pradesh, Indiae, Bhargavi Vemulapalli, K Kameswara Rao
7. Annals of Nigerian Medicine / Jan-Jun 2012 / Vol 6 | Issue 1
A study of prevalence of anemia and sociodemographic factors associated with anemia among pregnant women in Aurangabad city, India
Pushpa O. Lokare, Vinod D. Karanjekar, Prakash L. Gattani, Ashok P. Kulkarni
Departments of Community Medicine, Dr. Panjabrao Deshmukh Memorial Medical College, HFWTC, Amravati, Government Medical College, Aurangabad, and Maharashtra University of Health Sciences, Nashik, Maharashtra, India
8 .Int J Biol Med Res. 2012; 3(2): 1482-1484
Prevalence of anaemia amongst women in the reproductive age group in a rural area in south india Raghuram V, Manjula Anil, Jayaram S . Assistant Professor, Department of Community Medicine, A J Institute of Medical Sciences, Mangalore, Karnataka
10.Indian Journal of Community Medicine,Vol XXVII,No.4,Oct-Dec 2012
Prevalence of anaemia amongst pregnant women and its socio demographic associates in a rural area of Delhi.Virender P.Gautam,Yogesh Bansal,D.K.Taneja,Renuga Saha
Dept.of Community Medicine,Maulana Azad Medical College,New Delhi.
11 .Al Ameen J Med S ci (2 012 )5 (3 ):21 6 -2 2 3 Prevalence of Anaemia and Its Epidemiological Determinants in Pregnant Women R.G. Viveki, A.B. Halappanavar, P.R. Viveki, S.B. Halki, V.S.
Maled and P.S. Deshpande
Department of Community Medicine, Belgaum Institute of Medical Sciences, Belgaum, Karnataka, India Department of Anatomy, J.N. Medical College, Belgaum, Karnataka, India 12. Nutrition Foundation of India-Anaemia in pregnancy-Interstate differences.By N. Agarwal, D.K. Agarwal, Anshu Sharma Project funded by Department of Family Welfare, Government of India
Scientific Report 16 ,2005.
13. Journal of North East India Studies Vol. 3, No. 1, Jan.-Jun. 2013, pp. 74-85.
Maternal Anaemia, Pregnancy Complications and Birth Outcome: Evidences from North-East India Mousumi Gogoi, Ranjan Kumar Prusty
14.The National Medical Journal of India,Vol 13,No.5, 2000 Maternal anaemia: A persistent problem in rural Tamil Nadu,Jolly Rajarathinam,Rajarathinam
Abel,C.Ganesan,S.Amalan Jeyaseelan
12.Preliminary work already done by the investigator in this problem Nil
12. List of publications of the investigator in the field Nil
13. Structured abstract
Aim of the study: 1. This study aims at finding out the prevalence of anaemia and correlate with risk factors for its occurrence
2. Make recommendations for prevention and correction of anaemia in pregnant women Material and Methods: All eligible pregnant women, attending their first antenatal visit at CMCH will be recruited into the study after informed consent. This will include all women attending the General or Private Clinic, irrespective of their gestational age and obstetric risk factors.
They will be requested to give a blood sample for HEMOGLOBIN estimation , within a month of the booking visit. A proforma which contains demographic details, financial status, dietary patterns, obstetric risk factors will be filled up by the PI.
The Hemoglobin reports will be followed up. If the woman is anemic as assessed by the WHO standards, further test may be ordered as per standard protocol. These will be noted as well.
Analysis of data will be done and risk factors will be correlated.
13. Detailed diagrammatic Algorithm of the study
All pregnant women at booking visit are recruited after informed consent
Blood sample given for Haemoglobin estimation and proforma filled up
Follow up of Haemoglobin report
Analysis of demographic data and risk factors
14. Detailed research plan:
a. Setting: Describe the setting, locations, and relevant dates, including periods of recruitment, exposure, follow-up, and data collection
Out Patient Department,
Department of Obstetrics and Gynaecology, Christian medical College,
Vellore.
Inclusion criteria
All pregnant women attending antenatal OPD services on all OPD days Both General and Private patients will be included
Pregnant women at first visit at any gestational age Informed consent will be obtained
Eligible women will be requested to give blood samples for haemoglobin estimation on the same day or within a month of their first visit. Hemoglobin estimation will be done in the clinical Pathology laboratory by using automated machine.
A proforma containing questions regarding demographic data, financial status obstetric, dietary, Hemoglobin level and other relevant data will be filled in.
Results will be followed up and analysed along with the other data collected b. Participants: Give the eligibility criteria, and the sources and methods of case
ascertainment and control selection. Give the rationale for the choice of cases (and controls, if applicable). For matched studies, give matching criteria and the number of controls per case
Pregnant women coming to our hospital for the first time during the present pregnancy will be the participants as our study aims to find out the prevalence of anaemia in the booking visit to CMC&H, in Vellore.
c. Variables: Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers. Give diagnostic criteria, if applicable
Primary outcome : Prevalence of anemia in pregnant women at first visit Secondary outcomes : Grading of severity of anemia
Factors associated with presence or absence of anemia
Potential effect modifier : If Hemoglobin estimation is done only after treatment has been started in CMCH. Since, only a months time is allowed for Hemoglobin estimation from the date of the first visit, estimation may not be affected.
Anemia will be diagnosed based on WHO definition and severity will be graded Mild 10 to 10.9gms %
Moderate 7 to 9.9 gms % Severe < 7 gms %
d. Data Sources/measurement: For each variable of interest, give sources of data and details of methods of assessment (measurement). Describe comparability of assessment methods if there is more than one group
Method of assessment : Cyan methemoglobin method
The method for hemoglobin determination is the cyanmethemoglobin method (This is a type of colorimetric method). The principle of this method is that when blood is mixed with a solution containing potassium ferricyanide and potassium cyanide, the potassium ferricyanide oxidizes iron to form methemoglobin. The
potassium cyanide then combines with methemoglobin to form cyanmethemoglobin, which is a stable color pigment read photometrically at a wave length of 540nm
following Lambert-Beer’s Law and is directly proportionate to the haemoglobin levels in the blood.
Three advantages of the cyanmethemoglobin method are:
1. measures all forms of hemoglobin except sulfhemoglobin 2. can be easily standardized
3. cyanmethemoglobin reagent (also called Drabkin's solution) is very stable
Primi and Multigravida Definitions :
Primigravida : A woman who is pregnant for the first time
Multigravida : A pregnant woman who has been pregnant earlier
Family types Definitions : Ref : Park’s Preventive and Social Medicine 22nd edition
Nuclear Family / Elementary Family : Married couple and their children while they are still considered as dependants
Joint Family / Extended Family : A number of married couples and their children who live together in the same household
Third generation Family : Household where there are representatives of three generations.Usually occurs when young couples are unable to find separate housing accomadation and continue to live with their parents and have their own children.thus representatives of three generations related to each other by direct descent live together.
Modified Kuppuswamy’s Scale is used for Socio Economic Status (Revised table for scales in 2012 to define socioeconomic status) Ref : International Journal of Research &
Development of Health. Jan 2013; Vol 1(1): 2-4.
e. Bias: Describe any efforts to address potential sources of bias Nil
f. Sample size:(It may be suitable to have a statistician as a co-investigator)
Sample Size:
Single Proportion - Absolute Precision
Expected Proportion 0.33 0.33 0.33
Precision (%) 5 4 3.3
Desired confidence level (1- alpha) % 95 95 95
Required sample size 340 531 780
The prevalence of anaemia has been reported to be ranging from 33% to 89%
(Ref : Toteja GS, Singh P, Dhillon BS et al. Prevalence of anemia among pregnant women and adolescent girls in 16 districts of India. Food and Nutrition Bulletin 2006; 27(4):311-315)
However, we have considered that this prevalence would be at the worst 33%. In order to estimate this with the precision of 5%, 4% and 10% of 33% (3.3%), with 95% CI, the sample size needed ranged from 340 to 780 respectively. And, it was decided to study 600 pregnant mothers.
g. Quantitative variables: Explain how quantitative variables will be handled in the analyses. If applicable, describe which groupings were chosen and why
Modified Kuppuswamy’s Scale is used for Socio Economic Status (Revised table for scales in 2012 to define socioeconomic status) Ref : International Journal of Research &
Development of Health. Jan 2013; Vol 1(1): 2-4.
(A) Education Score
1. Profession or Honours 7
2. Graduate or post graduate 6
3. Intermediate or post high school diploma 5
4. High school certificate 4
5. Middle school certificate 3
6. Primary school certificate 2
7. Illiterate 1
(B) Occupation Score
1. Profession 10
2. Semi-Profession 6
3. Clerical, Shop-owner, Farmer 5
4. Skilled worker 4
5.Semi-skilled worker 3
6. Unskilled worker 2
7. Unemployed 1
(C) Monthly family income ( in Rs Score Modified for 2012 )
1. ≥ 2000 12 ≥ 13500 ≥32050
2. 1000-1999 10 6750 - 13499 16020 – 32049
3. 750-999 6 5050 - 6749 12020 – 16019
4. 500-749 4 3375 - 5049 8010 – 12019
5. 300-499 3 2025 - 3374 4810 – 8009
6. 101-299 2 676 - 2024 1601 – 4809
7. ≤ 100 1 ≤ 675 ≤ 1600
Total Score Socioeconomic class 26-29 Upper (I)
16-25 Upper Middle (II)
11-15 Middle/Lower middle (III) 5-10 Lower/Upper lower (IV)
<5 Lower (V)
h. Statistical methods: Describe all statistical methods, including those used to control for confounding and examine subgroups and interactions. How will missing data be handled? If applicable, how will matching of cases and controls be handled? Describe any proposed sensitivity analyses.
Data will be entered in Epidata software with quality control checks such as range and consistency. Data will be analysed using SPSS 19.0 software. Data will be further screened using Box-Cox plot and histograms. The prevalence will be presented as point estimate with 95%CI. These statistics will be presented separately for different age groups and risk groups.
The risk factor will be analysed using Student t test and chi-square test. Anemia (yes/no) will be considered as a dependent variable. As bi-variate analyses, the effect of risk variable will be presented as OR and 95% CI. Logistic Regression analyses will be done with log link as the prevalence was >10%. Nagelkerke R and Hosmer and Lemeshow chi-square statistics will also be presented as goodness of fist statistics.
i. Name & designation of the statistician involved in your project for Statistical Analyses:
Dr.Jeyaseelan, Professor and Head,
Department of Biostatistics, Christian Medical College,Vellore.
15. Complete budget plan
For FLUID research grant money cannot be allocated for travel of the investigators nor can job outsourcing be covered with FLUID grants. Funding out of the institution can be given only for the special mission hospital grant
(From Fluid Research Fund, there are no grants for personnel except in a major grant application, funding is limited Rs. 50,000/- per year for two years for standard applications, Rs. 2,00,000/- per year for two years for major applications). Website link:
http://172.16.11.136/Research/#. > Rules for Major Fluid Research Grants. Do not exceed the budget allocated to you. In case the budget is exceeded, the amount will have to be deducted from one of your departmental special funds. Stationary, printing material and paper should not exceed more than 20% of the allocated fluid grant.
Please mention below the breakdown of budget requested: (The budgets that are drawn up should be comprehensive and should mention all subject in detail (For example – laboratory investigation should mention the specific category without generalization.)
16. If this is an application for Fluid Research Funding, please provide name and account number of any other Fluid Research grant held by the PI. Not applicable
S. No Study Title IRB Min. No.
and date Grant Sanctioned
amount/ Account Head Duration /
Year Study ongoing/
completed
17. Informed Consent Documents (patient information sheet, investigator’s brochure, drug information etc and informed consent document) please submit all translations with the proposal.
PATIENT INFORMATION SHEET & INFORMED CONSENT FORM
DEPT.OF OBSTETRICS AND GYNAECOLOGY CHRISTIAN MEDICAL COLLEGE VELLORE
Part : 1- Information Sheet
This sheet provides you the details about the research study in which you are requested to take part.The study is done on pregnant women when they come to our OPD, the first time for antenatal care.The study is done to findout the number of pregnant mothers with anaemia,a condition which is diagnosed when the haemoglobin levels in the blood fall below 11 gms%.
India is one of the countries with very high prevalence of anaemia in the world. Almost 58%
of pregnant women in India are anaemic and anaemia is one of the common causes of many serious complications during pregnancy and delivery.
Taking cognizance of all these facts ,in CMC, we have planned to do this study. When you decide to take part in this study you will be asked to give your blood sample for estimation of haemoglobin levels and a proforma will be filled by collecting some details from you after signing the consent form.
This blood sample for haemoglobin will usually be requested by the doctor even if you do not agree to participate in this study.
Part : 2 – Consent Sheet
Study Title : Prevalence of Anaemia in Pregnancy Study Number: ____________
Subject’s Initials: __________________ Subject’s Name: _________________________________________
Date of Birth / Age: ___________________________
(i) I confirm that I have read and understood the information sheet dated ____________ for the above study and have had the opportunity to ask questions.
(ii) I understand that my participation in the study is voluntary and that I am free to withdraw at any time, without giving any reason, without my medical care or legal rights being affected.
(iii) I understand that the Sponsor of the clinical trial, others working on the Sponsor’s behalf, the Ethics Committee and the regulatory authorities will not need my permission to look at my health records both in respect of the current study and any further research that may be conducted in relation to it, even if I withdraw from the trial. I agree to this access. However, I understand that my identity will not be revealed in any information released to third parties or published.
(iv) I agree not to restrict the use of any data or results that arise from this study provided such a use is only for scientific purpose(s).
(v) I agree to take part in the above study.
Signature (or Thumb impression) of the Subject/Legally Acceptable Date: _____/_____/______
Signatory’s Name: _________________________________ Signature:
Or
Representative: _________________
Date: _____/_____/______
Signatory’s Name: _________________________________
Signature of the Investigator: ________________________
Date: _____/_____/______
Study Investigator’s Name: _________________________
Signature or thumb impression of the Witness: ___________________________
Date: _____/_____/_______
Name & Address of the Witness: __________________________
18.Publication Plans: (List all potential authors and their likely contributions) (Please tick √ appropriate box)
Responsibilities Author(s)
Name Research and Study design
Data collection
& analysis
Laboratory
Analysis Interpretation and
conclusion
Preparation of
Manuscript
Review of
Manuscript Guide and critical revision
Administration Technical Support Dr,Madhu
Priya N √
√ √ √
√ √ Dr.Ruby
Jose
√ √ √
√
√ √ Dr.Reeta V.
Selvi √ √
√
√ Dr.Jeya
Seelan √ √ √
18. Inter-departmental cooperation: (Please describe the arrangements with institutional diagnostic service units/departments that are being used for this research project, if applicable).
Nil
19. Signature of Principal Investigator
20. Signature of Guide/Head of the Department/ Unit
21. Co-Investigators’ Consent (all co-investigators have to sign this form or supply separate letters of consent)
I/We give my/our consent to be a Co-Investigator and provide my/our expertise to the project. I/We have approved this version of the protocol and have contributed substantially to its development.
Name Department Signature Date
Dr.Ruby Jose OG IV Dr.Reeta Vijayaselvi OG IV
Dr.L.Jeyaseelan Biostatistics
Section II
APPLICATION FOR APPROVAL FROM ETHICS COMMITTEE OF THE INSTITUTIONAL REVIEW BOARD OF CMC VELLORE FOR ALL OBSERVATIONAL (CASE CONTROL, COHORT &
OBSERVATIONAL) STUDIES IN HUMAN SUBJECTS
1. Please provide a brief summary of the justification, objectives and methods in lay language, avoiding technical terms.
As anemia (LOW BLOOD LEVELS) is the cause for 20% of the deaths of mothers in India, steps should be taken to reduce prevalence of anemic mothers in our country. But inspite of some efforts from the Government programmes, anaemia is still the leading cause of preventable deaths among pregnant women. The programmes implemented so far are low cost effective treatment plans but yet unable to reach the targets. A study was done in 2000 by the RUHSA department .Since this study was more than 14 years old, recent prevalence is planned in this study.This study is planned to assess the prevalence and the probable reasons for anaemia in our pregnant population. With the analysis of data obtained from this study regarding the number of pregnancies, dietary intake, pregnancy
complications, iron medication intake, some recommendations could be suggested for preventive action.
2. Please describe if the study uses procedures already being performed on patients for diagnosis or treatment or if modified or novel procedures are to be used?
Yes , Haemoglobin estimation is already a routine test for all pregnant mothers
3. Please describe what benefits might be reasonably be expected by the participant as an outcome of participation
Hemoglobin levels ,if low will be intimated and treatment plans made accordingly
4. Please describe what benefits to others or new knowledge might be expected as a result of this study
Even after implementation of all Government health programmes, anaemia continues as a major mortality and morbidity determinant in our country. After this study,We will know the prevalence of the anaemia problem in our populationa and we will be able to assess the effectiveness and the problems of our health services offered. We will be able to improve our management if we could find some correlation between some risk factors and the severity of anaemia.
5. Who are to be enrolled?
Pregnant women coming to our hospital for the first time in the present pregnancy
6. If any vulnerable groups (e.g., pregnant women, children) are to be enrolled, please provide a justification for their inclusion.
Study is done for the betterment of pregnant mothers
7. If any economically disadvantaged individuals are to be enrolled, please provide a justification for their inclusion.
Nil
8. What are the potential risks to participants in this study?
Nil
9. Are the risks to participants reasonable in relation to the benefits that might reasonably be expected as an outcome to the participant or to others, or the importance of the knowledge that may reasonably be expected to result? Please provide a detailed description of the above.
Not applicable
10. Regarding informed consent to obtained from research participants or their legally authorized representative(s):
a. Does the informed consent document include all the required elements?
Yes
b. Are the participant information sheet and the consent document in language understandable to participants? (PLEASE PROVIDE WITH THIS SUBMISSION TRANSLATIONS IN ALL LOCAL LANGUAGES ANTICIPATED TO BE USED).
Yes
c. Who will obtain informed consent (PI, nurse, other?) and in what setting?
PI , or suitable Registrar in the OPD.
d. If appropriate, is there a children’s assent? If yes, please submit a copy of this form.
Not applicable
e. Is the EC requested to waive or alter any informed consent requirement?
No
11. Is there provision of free treatment for research related injury? If yes, who will provide it?
Not applicable
12. Is there provision for compensation of participants for disability or death resulting from research related injury. If yes, who will provide it?
Not applicable
13. Is the study covered by insurance? If yes, please provide insurance documents from an Indian insurance company.
Not applicable
14. In addition to the overall budget in Section I, please provide details of the following i) Justification, timing and amount of payments to study participants not applicable ii) Justification, timing and amount of payments to investigators/departments
iii) Any other study related financial or in kind incentives to participants or study staff
15. Please describe the plan for maintaining confidentiality of study participant information.
Hemoglobin estimates are normally posted on the antenatal card.
Information regarding demographic and other data will be maintained confidentially, access to data will be restricted to PI.
16. Please describe the plans for monitoring the safety of participants, reporting and managing adverse events. If this is an externally funded study with a Data Safety Monitoring Board, please provide the name and contact information of the DSMB chairperson.
Not applicable
17. If applicable; please provide all significant previous decisions (e.g., those leading to a negative decision or modified protocol) by other ECs or regulatory authorities for the proposed study (whether in the same location or elsewhere) and an indication of the modification(s) to the protocol.
18. If appropriate, has permission from the Drug Controller General of India been obtained?
Not applicable
19. If this is international collaborative research, has permission from the Health Ministry’s Screening Committee been obtained?
Not applicable
20. For exchange of biological material in international collaborative studies, please provide a Memorandum of Understanding (MOU)/ Material Transfer Agreement (MTA) between the collaborating partners.
Not applicable
21. Declaration (to be signed by all investigators)
By signing this form we give our consent to provide our expertise to the project. In addition:
a. We confirm that all investigators have approved this version of the protocol and have contributed substantially to its development.
b. We confirm that all potential authors are included in this protocol.
c. We confirm that we shall submit any protocol amendments, significant deviations from protocols, progress reports (if required) and a final report and also participate in any audit of this study, if required.
d. We confirm that we shall conduct this study in accordance with the Declaration of Helsinki;
the ICMR Guidelines for Biomedical Research in Human Subjects 2006, with any subsequent amendments; and all applicable laws of the land.
e. We also agree to submit for publication to a peer reviewed journal the complete results of this study within two years of completion of this study.
f. We declare that we have no conflicts of interest that may affect the conduct or reporting of this study (OR) we declare the following conflicts of interest below.
g. We are aware of the institution’s policies regarding scientific misconduct (Falsification/fabrication/plagiarism) and agree to abide by them.
22. Signature of Principal Investigator
23. Signature of Guide/Head of the Department/ Unit
24. Co-Investigator’s Consent (all co-investigators have to sign this form or supply separate letters of consent)
Name Department Signature Date
Dr.Ruby Jose OG IV Dr.Reeta Vijayaselvi OG IV
Dr.L.Jeyaseelan Biostatistics
Section III
CHECKLIST FOR PROTOCOLS SUBMITTED TO IRB OF CMC VELLORE FOR OBSERVATIONAL (CASE CONTROL, COHORT & CROSS SECTIONAL) STUDIES
Please tick the appropriate boxes below to indicate that the following have been submitted and if not, please explain why:
1. Form for protocols of Observational Studies with all sections (I, and II) completed [ √ ]
2. Informed consent sheet and participant information sheet in all relevant local languages (PDF Format) [√ ]
3. Names, affiliations and signatures of all investigators/co-investigators for the declaration [ √ ] 4. Signature of the Head of the department or unit as applicable (for interdepartmental studies,
an agreement letter from concerned departmental heads is desirable, especially if they are not co-investigators). [Not interdepartmental study ]
5. Recent curriculum vitae of all the investigators indicating qualification and experience and relevant publications in the past five years. [√ ]
6. If applicable, proposed compensation and reimbursement of incidental expenses and management of research related and unrelated injury/ illness during and after research period. [Not applicable]
7. If applicable (in study-related injuries), a description of the arrangements for insurance
√coverage for research participants and copy of insurance documents from an India insurance agency. [Not applicable]
8. If applicable; all significant previous decisions (e.g., those leading to a negative decision or modified protocol) by other ECs or regulatory authorities for the proposed study and an indication of the modification(s) to the protocol made on that account. The reasons for negative decisions should be provided. [Not applicable]
9. Plans for publication of results - positive or negative - while maintaining the privacy and confidentiality of the study participants, with names of proposed authors and their expected contributions. [√ ]
10. All other relevant documents related to the study protocol like product information and statement of relevant regulatory clearances. [√ ]
11. If applicable, any material used for advertisement to recruit participants to the study - this may include flyers, brochures, posters, radio and TV advertisements. [Not applicable]
12. For externally funded studies, details of Funding agency/ Sponsors and breakdown of fund allocation. [Not applicable]
13. One hard copy and a soft copy on CD or e-mail to research@cmcvellore.ac.in of all the above.
[√ ]
Please list below all additional documents that are being submitted along with this application including all appendices.
1.Proforma of the study
2.Consent forms in Tamil and Telugu
Notes for filling in this form
1. Section I is required for Research Committee Approval and application for Fluid Grants.
Section II is required for Ethics Committee Approval. Section III contains a checklist that should be filled and accompany this submission. (Incomplete submissions will be rejected).
2. Please also read the Standard Operating Procedure of the IRB of CMC Vellore (available from the Research website) for additional guidance on policies and procedures that will be followed at CMC for IRB approval. Website link: http://172.16.11.136/Research/IRB_Polices.html.
3. This form conforms to the requirements of the STROBE statement. An Explanation and elaboration article discusses each checklist item and gives methodological background and published examples of transparent reporting. The STROBE checklist is best used in conjunction with this article (freely available on the Web sites of PLoS Medicine at http://www.plosmedicine.org/ Annals of Internal Medicine at http://www.annals.org/ and Epidemiology at http://www.epidem.com/ ). Information on the STROBE Initiative is available at http://www.strobe-statement.org.
Research website link: http://172.16.11.136/Research/Flow%20chart.html.
4. Externally funded projects should also be submitted using this form, in addition to documentation provided by sponsors.
5. Submission procedure
Project proposal,
Curriculum Vitae’s
Information sheet and informed consent forms
The aforesaid in translated versions need to be in PDF format.
Signatures by all investigators and the Guide/Head of the Department/Unit need to be scanned.
Applications submitted after the due date will not be entertained.
6. It is mandatory to fill in the checklist (Section III)
Completed application with all supporting documents (Hard and Soft copy) should be submitted to:
Institutional Review Board, Christian Medical College
Office of Research, I st Floor, Carman Block, Bagayam, Vellore 632 002 India.
E-mail: research@cmcvellore.ac.in.
Tel: 0416 -2284294, 2284202 Fax: 0416 – 2262788, 2284481.
Hours for submission: 8.00 am to 5.00 pm (Monday – Friday) 8.00 am to 12.00 pm (Saturday)
in CMC&H, Vellore, urban Tamil Nadu.
Structured Abstract
Background :Anemia in pregnancy accounts for one fifth of maternal deaths worldwide and is a major factor responsible for low birth weight. In India, 16% of maternal deaths are attributed to anemia. The association between anemia and adverse pregnancy outcome, higher incidence of preterm and low–birth weight deliveries have been demonstrated. However, high prevalence of anemia among pregnant women persists in India despite the availability of effective, low-cost interventions for prevention and treatment. A knowledge of the sociodemographic factors associated with anemia will help to formulate multipronged strategies to attack this important public health problem in pregnancy.
Aims of the study:
1. This study aims at finding out the prevalence of anemia and correlate with risk factors for its occurrence.
2. Make recommendations for prevention and correction of anemia in pregnant Women
Objective Of the study:
To find out the prevalence of anemia in Obstetrics OPD patients during their first antenatal visit to CMCH, Vellore
Out Patient Department, Christian Medical College, Vellore, Tamil Nadu, India.
Study Design:
An observational study.
Materials and Methods:
600 pregnant women who came for their booking visit to the OPD were included in the study.
Statistical Analysis:
Prevalence was calculated as point prevalence with 95% CI.
Bivariate and multivariate analyses were used.
Results:
Overall prevalence of anemia among the pregnant women was 23.16% with mean Hemoglobin of 11.7 with SD of 1.29.
Factors such as occupation and ante natal checkups and iron and folic acid intake in pregnancy were found to be significantly associated with anemia in pregnancy (p <0.05)
Conclusion:
Working women, not had ante natal checkups and iron and folic acid tablets were found to have significant risk to develop anemia in pregnancy.
