Protocol Final
Protocol Final
Protocol Final
1. TITLE: A study on the Prevalence of Reproductive Tract Infections based on syndromic approach among married women aged 18 to 45 years in a rural area of Kancheepuram district, Tamilnadu, 2011 Principal Investigator: Dr. M. Geetha, Post Graduate, Institute of Community Medicine, Madras Medical College
Guide
Dr. V. V. Anantharaman, Assistant Professor, Institute of Community Medicine, Madras Medical College.
2. OBJECTIVES: (1) To estimate the prevalence of Reproductive tract infections (RTIs) among married women of reproductive age group (18 to 45 years) in Nandhivaram, Kancheepuram district (2) To find out if there is any association between Reproductive tract infections and sociodemographic, obstetric factors, contraceptive and menstrual hygiene practices. 3. INTRODUCTION:
Reproductive tract infections (RTIs) including Sexually transmitted infections (STIs) are a common and serious health problem worldwide. An estimated 340 million new cases of curable STIs occur each year, with 151 million of them in South and Southeast Asia. RTIs cause considerable discomfort and lost economic productivity among both males and females. The most long term sequelae arise in women: pelvic inflammatory disease, cervical cancer, infertility, spontaneous abortion and ectopic pregnancy, the latter of which may lead to maternal death. The presence of an STI increases the risk of acquiring and transmitting HIV infection by three to five times. NFHS-2 estimates reveal a high reported prevalence of reproductive health problems across women in all socioeconomic groups of population. Nearly 4 out of 10 currently married women in India report at least one reproductive health problem that
could be symptomatic of a more serious RTI. This estimate for Tamilnadu is 27.8% (urban 53%; rural 50%). Among these one half (51%) have not sought any treatment. According to DLHS-3 survey about 18% of women in India reported as having at least one symptom of RTI/STI. In India married women are reluctant to seek medical treatment because of the social stigma attached. The women of reproductive age group constitute about one fifth (22.2%) of the population of India. Therefore the unreported and untreated RTIs in this group of population creates a huge disease burden in the community. One of the important components of the Reproductive and Child Health Program is to lead a healthy sexual life without any fear of pregnancy or contracting disease. This study is an attempt to identify the magnitude of RTIs and associated risk factors among married women of reproductive age group in a rural area of Tamilnadu.
4. JUSTIFICATION: 1. According to NFHS 2, nearly 4 out of 10 currently married women in India report atleast one reproductive health problem that could be symptomatic of a more serious Reproductive tract infection. 2. According to DLHS 3 (2007-08), the awareness about Reproductive tract infections is lesser in rural areas (22.7%) compared to urban areas (32.9%). 3. The percentage of women reporting symptoms of Reproductive tract infections is much higher in rural areas (7.5%) compared to urban areas (5.8%). 4. Reproductive tract infections including Sexually transmitted diseases cause considerable morbidity, particularly in relation to the reproductive health of women, and are also associated with increased transmission of HIV. 5. Women do not have equal access to and control over resources such as money, transport and time as men. Because the decision-making power within the family is unequal, with men enjoying privileges that women are denied, womens access to health services is restricted. 6. The stigma attached to visiting a health facility further discourages women from seeking treatment. 7. Delay in seeking health care can allow for continued transmission and greater probability of adverse sequelae.
8. WHO recommended Syndromic diagnosis and treatment allows for easier diagnosis and treatment of Reproductive tract infections including Sexually transmitted diseases in a resource poor setting like ours.
5. METHODOLOGY: (1) Study Design (2) Study Place (3) Study Duration (4) Study Population : Community based Cross sectional study : Nandhivaram, Saidapet HUD : June 2011 to October 2011 : Married women of reproductive age group (15-45 years)
(5) Inclusion Criteria : Married women in the age group of 15 to 45 years (6) Exclusion Criteria : - Women who were pregnant - Women with significant medical or gynaecological problem - Women not willing to participate : 480 (7) Sample Size The sample size was calculated based on the prevalence of reproductive tract infections among married women in the reproductive age group in the rural area of Sirmour district in Himachal Pradesh which is 51.9%. 95% confidence interval, 10% precision and design effect of 2. Z alpha = 1.96, p= 51.9%, q= 48.1%. d is allowable error of 9% of 51.9% = 4.7. Sample size: 1.96 x 1.96 x 51.9 x 48.1 = 435 4.7 x 4.7 Assuming 10% non-responsiveness, the sample size is calculated to be 480. (8) Sampling method: Nandhivaram PHC area of Saidapet HUD was chosen by lottery method. Nandhivaram PHC is a Block PHC, 6 Health Sub centres (HSC). Among the 6 HSCs, Kamarajapuram HSC was chosen randomly. The sample is chosen by Simple Random technique from the Sampling frame obtained from the Eligible Couple Register of Kamarajapuram HSC during the study period.
(9) Questionnaire: A semi structured questionnaire based on Ever married womens questionnaire from District Level Household Survey (DLHS) 3, under Reproductive and Child Health Project will be used in the study to collect information from the participants after obtaining informed consent. The questionnaire is divided into 6 parts 1. sociodemographic details, 2. perceived symptoms of RTI based on WHO syndromic diagnosis, 3. obstetric history, 4. contraceptive practices, 5. personal and menstrual hygiene practices and 6. treatment seeking behaviour. The questionnaire is modified according to the purpose of the study. It is prepared both in English and local languages (Tamil). The questionnaire will be pre tested and changes will be made according to the observations. (10) Data collection and methods: Data collection will be done in the study area after obtaining permission from The Dean and the Director, Institute of Community Medicine, Madras Medical College and the Director of Public Health and Preventive Medicine of Tamil Nadu, Deputy Director of Health services of Saidapet, the Block Medical Officer of the Primary Health Centre of Nandhivaram. Data will be collected by simple random sampling with the sampling frame by house to house visit in the study area. After a brief introduction and obtaining their informed consent, relevant information will be obtained from the respondent using the semi structured questionnaire in the local language. (11)Analysis plan: Data will be entered into MS Excel and analysis will be done using SPSS software.
ANNEXURE I BIBLIOGRAPHY
1. International Institute for Population Sciences, District Level Household Survey, Under Reproductive and Child Health Project, 2007-2008, India, Report. 2. International Institute for Population Sciences, District Level Household Survey, Under Reproductive and Child Health Project, 2007-2008, Fact sheet, Tamilnadu. 3. International Institute for Population Sciences & ORC Macro, National Family Health Survey-2, India- Key findings, 1998-99, p 14. 4. Operational Guidelines for Programme Managers and Service Providers for Strengthening STI / RTI Services, October 2007, National AIDS Control Organization, MOHFW, New Delhi. 5. National Guidelines on Prevention, Management and Control of Reproductive Tract Infections including Sexually Transmitted Infections, August 2007, NACO & MOHFW. 6. Shireen Jejeebhoy, Michael Koenig, Christopher Elias, WHO (2003), Investigating Reproductive Tract Infections and Other Gynaecological Disorders- A Multidisciplinary Research Approach, Cambridge University Press, p 1-10. 7. V Patel, H A Weiss, D Mabey et. al. The burden and determinants of reproductive tract infections in India: a population based study of women in Goa, India, Sex Transm Infect 2006; 82:243249. 8. Savita Sharma, BP Gupta, (2009) The Prevalence of Reproductive Tract Infections and Sexually Transmitted Diseases Among Married Women in the Reproductive Age Group in a Rural Area, Indian Journal of Community Medicine, Vol 34, Issue 1, January 2009 ; 63-65. 9. Jasmin Helen Prasad, Sulochana Abraham, Kathleen M. Kurz, Valentina George, M. K. Lalitha et. al. Reproductive Tract Infections Among Young Married Women in Tamil Nadu, India, International Family Planning Perspectives, 2005, 31(2):73 82. 10. Ch. Satish Kumar , S.D. Gupta, Dhirendra Kumar, J.P. Singh and Rahul Bhawsar, Reproductive Tract Infections and Their Associated Risk Factors Among The Women in Bundi District of Rajasthan, J. Hum. Ecol., 13(4): 307-310 (2002). 11. Thomas K, Thyagarajan SP, Jeyaseelan L, et al. Community prevalence of sexually transmitted diseases and human immunodeficiency virus infection in Tamil Nadu, India: a probability proportional to size cluster survey. Nat Med J India 2002;15:13540.
12. Vishwanath S, Talwar V, Prasad R, et al. Syndromic management of vaginal discharge among women in a reproductive health clinic in India. Sex Transm Infect 2000; 76:3036. 13. Garg S, Sharma N, Bhalla P, Sahay R, Saha R, Raina U, et al. Reproductive morbidity in an Indian urban slum: Need for health action. Sex Transm Infect 2002; 78:689. 14. Bang RA, Bang AT, Baitule M, Choudhary T, Sarmukaddam S, Tale O. High prevalence of gynaecological diseases in rural Indian women. Lancet 1989; 1:85 8. 15. Nandan D, Misra SK, Sharma A, Jain M. Estimation of prevalence of RTIs/STDs among women of reproductive age group in Dist. Agra, J Med 2002;37:1103. 16. Aggarwal AK, Kumar R, Gupta V, Sharma M. Community based study of reproductive tract infections among ever married women of reproductive age in a rural area of Haryana, India. J Commun Dis 1999; 31:2238. 17. Thakur JS, Swami HM, Bhatia SPS. Efficacy of syndromic approach in management of reproductive tract infections and associated difficulties in a rural area of Chandigarh. Indian J Community Med 2002; 27:1103. 18. Rani M and Bonu S, Rural Indian womens care-seeking behaviour and choice of provider for gynaecological symptoms, Studies in Family Planning, 2003, 34(3):173185. 19. Krishna Ray, Sumathi Muralidhar, Manju Bala, et.al. Comparative study of syndromic and etiological diagnosis of reproductive tract infections/sexually transmitted infections in women in Delhi, International Journal of Infectious Diseases (2009) 13, 352359. 20. Indra P. Kambo, B.S. Dhillon, Padam Singh, B.N. Saxena, N.C. Saxena self reported gynaecological problems from Twenty three districts of India (an ICMR task force study), Indian Journal of Community Medicine, Vol. XXVIII, No.2, Apr.-June, 2003.
ANNEXURE II
BIO DATA OF THE INVESTIGATOR 1. Name 2. Designation 3. Complete Postal Address, : Dr. Geetha. M. : Post Graduate, M.D. Community Medicine : Institute of Community Medicine Madras Medical College, Chennai- 600003. E-mail ID, Phone no. : drgeethammc@gmail.com 94442-20555 4. Date of Birth 5. Educational qualification Degree M.B.B.S. D.C.H. MD Community Med : 04.03.1981 : Institution Kilpauk Medical College Kilpauk Medical College Madras Medical College Year 1998 -2004 2006 -2008 2009-
6. Research/ Training Experience: (a). Principles and Practice of Epidemiology- Workshop Christian Medical College, Vellore- August, 2009. (b). The Research Methodology Workshop Institute of Obstetrics and Gynaecology, Chennai- October, 2009. (c) Research Methodology and Biostatistics Workshop The TN Dr. MGR Medical University, Chennai, Jan 31-Feb 4, 2011
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