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SYNOPSIS Rajiv Gandhi University of Health Sciences, Karnataka, Bangalore “ SCREENING OF BACTERIAL VAGINOSIS IN PREGNANT WOMEN AND ITS OUTCOME ON PREGNANCY IN PATIENTS ATTENDING A TERTIARY CARE HOS PITAL OF DAKSHINA KANNADA DISTRICT IN COASTAL KARNATAKA” Name of the candidate : Dr. Lumbeni Kithan Guide : Dr. Anup Kumar Shetty Course and Subject : M.D (Microbiology) DEPARTMENT OF MICROBIOLOGY FR. MULLER MEDICAL COLLEGE HOSPITAL KANKANADY, MANGALORE – 575002 AUGUST 2012 0 RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA, BANGALORE ANNEXURE II PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION 1. Name of the candidate and address DR. LUMBENI KITHAN POST GRADUATE RESIDENT DEPT OF MICROBIOLOGY FATHER MULLER MEDICAL COLLEGE KANKANADY MANGALORE – 575002 2. Name of the Institution FATHER MULLER MEDICAL COLLEGE KANKANADY MANGALORE – 575002 3. Course of study and subject MD IN MICROBIOLOGY 4. Date of admission to the course 29.05.12 5. TITLE OF THESIS: “SCREENING OF BACTERIAL VAGINOSIS IN PREGNANT WOMEN AND ITS OUTCOME ON PREGNANCY IN PATIENTS ATTENDING A TERTIARY CARE HOSPITAL OF DAKSHINA KANNADA KARNATAKA”. 1 DISTRICT IN COASTAL 6. BRIEF RESUME OF THE INTENDED WORK 6.1 NEED FOR STUDY Bacterial vaginosis though a much studied disease still lacks definite answers especially in pregnancy and in Indian context. Empirical treatment, based only on clinical criteria, leads to misdiagnosis and wrong treatment hence needs to be evaluated by correlation with proper lab diagnosis. Early screening, diagnosis and treatment of bacterial vaginosis in pregnant women may be helpful in preventing complications resulting out of it. 6.2 REVIEW OF LITRATURE Bacterial vaginosis is a condition in women where the normal balance of bacteria in the vagina is disrupted and replaced by an overgrowth of pathogenic bacteria.(1) Bacterial vaginosis is the most common lower genital tract disorder among women of reproductive age (pregnant and non pregnant) and the most prevalent cause of vaginal discharge, itching and malodour.(1,2)Normal vaginal flora consists of both aerobic and anaerobic bacteria, with Lactobacillus species being the predominant microorganisms and accounting for greater than 95% of all bacteria present.(2) Lactobacilli are believed to provide defence against infection, in part by maintaining an acidic pH in the vagina. In contrast, bacterial vaginosis is a poly-microbial syndrome resulting in a decreased concentration of lactobacilli and an increase in pathogenic bacteria, mainly anaerobic or microaerophiles. These organisms include Gardnerella vaginalis, Mobiluncus species, Bacteroides Mycoplasma species.(2,3) 2 species, Prevotella species and Bacterial vaginosis is a strong independent risk factor for adverse pregnancy outcomes.(4) It has been associated with a significant number of obstetric and gynaecologic complications such as preterm labour and delivery, preterm premature rupture of membranes, spontaneous abortion, chorioamnionitis, postpartum endometritis, post-caesarean delivery wound infections, postsurgical infections, and subclinical pelvic inflammatory disease.(2) Embryo foetal infections have been reported to cause recurrent spontaneous abortions (RSA) at a rate lower than 4%.(5) In studies of private clinic patients, the prevalence has ranged from 4% to 17%, while in gynaecology clinics it has been 23%.In college students, the prevalence has ranged from 4% to 25%, while it has been as high as 61% in women attending sexually transmitted disease clinics.(2) In pregnant women, studies have documented similar prevalence rates to those seen in non-pregnant populations, ranging from 6% to 32.(2) Other studies have indicated a prevalence of 9% to 23% pregnant women.(4) There are several risk factors for the acquisition of bacterial vaginosis. It has been associated with racial origin (more in blacks), smoking, sexual activity, and vaginal douching.(2,6)Early screening, diagnosis and treatment of bacterial vaginosis in pregnant women may be helpful in preventing complications resulting out of it. 6.3 OBJECTIVE OF THE STUDY 1. To study the prevalence of bacterial vaginosis in pregnant women. 2. To find out if screening process should be evolved on regular basis in patients with high risk (Smoking, multiple sexual partners, race etc ) 3. To study risk factors if any, relating bacterial vaginosis and pregnancy. 3 7. MATERIALS AND METHODS: 7.1 SOURCE OF DATA The study will be carried out in the Department of Microbiology, Father Muller Medical College, Mangalore, for a period of one and a half year. Specimen will be collected from patients attending OPD (Out Patient Department) and IP (In-Patient) of Father Muller Medical College and Hospital (FMMCH). 7.2 METHOD OF COLLECTION OF DATA: Inclusion criteria: All Pregnant women of any age group attending as out-patients or in-patients to Father Muller Medical College Hospital, Kankanady, Mangalore, Karnataka State, with symptoms of discharge per vagina, itching, burning sensation in vagina, history of recent sexual activity and history of recent urinary tract infection will be screened in the study. Exclusion criteria. Non-pregnant women Pregnant women with no symptoms STUDY TYPE: Prospective SAMPLE & SAMPLING TECHNIQUES: The sample size will be150 and samples will be collected as follows:Techniques: Vaginal swab collected by the OBG (Obstetrics and Gynaecology) department, from pregnant women and will immediately be transported to the laboratory for further examination. The details required will be noted in a questionnaire. Examination of the vaginal swab will be done as following: 4 A) Wet mount examination: The secretions from the swab will be smeared on a clean glass slide, which will be later covered with a cover slip. The slide will be first examined under low power and then under high power, to look for ‘clue cells’. B) Gram’s staining: The swab will be smeared on another clean glass slide, air dried and fixed with gentle heat. It will be stained by Gram’s staining method by adding crystal violet for one minute, wash with water, Gram’s Iodine for one minute, wash with water, Acetone for 2-3 seconds, wash with water and dilute carbol fuchsin for one minute, wash with water. After air drying the smear it will examined under oil immersion objective for short Gram negative or Gram variable bacilli (Gardnerella vaginalis), Curved Gram negative bacilli (Mobiluncus), epithelial cells with heavy coating of Gram negative bacilli on the periphery (clue cells) and thick Gram positive bacilli (Lactobacilli). The smear will be graded and interpreted based on Nugent’s score. Nugent’s Scoring of vaginal swabs for diagnosis of bacterial vaginosis. Morphotype Lactobacillus species Gardnerella & anaerobic Gram negative bacilli Curved Gram negative bacilli (Mobilincus species) Number of organisms per oil immersion field None <1 1-4 5-30 >30 4 3 2 1 0 0 1 2 3 4 0 1 1 2 2 Number based on average of 10 fields. Interpretation of Nugent’s score Nugent’s And score 0-3 No clue cells Interpretation Normal vaginal flora Intermediate or Not consistent with Bacterial vaginosis Indicative of bacterial vaginosis 4-6 No clue cells 4-6 Clue cell present Clue cell present or Indicative of bacterial vaginosis absent ≥7 5 C) Detection of pH: The vaginal swab was rubbed against a commercial pH paper and the pH will be interpreted based on the colour scale provided by the manufacturer. D) Whiff’s test: Two drops of 10% potassium hydroxide was added on the swab and development of an amine fishy odour was considered as a positive test. Other than fishy odour were considered negative. The diagnosis of bacterial vaginosis is made when three of the four following signs were present 1. An adherent and homogenous vaginal discharge. 2. Vaginal pH greater than 4.5 3. Detection of clue cells. 4. A Positive Whiff’s test. PLAN FOR DATA ANALYSIS: Collected data will be analysed by frequency percentage and by chi square test. 7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so please describe briefly. Yes .Vaginal swab for wet mount and Gram staining. 7.4 Has the ethical clearance been obtained from your institution in case of 7.3? Yes 6 8. LIST OF REFERENCES 1. Sexually transmitted diseases.(CDC Website) 2006.Available at http://www.cdc.gov/std/bv/STDFact-Bacterial-Vaginosis.htm (Cited on Sep 7 2012) 2. Yudin MH, Money DM, Boucher M, Cormier B, Gruslin A, Ogilvia G et.al. Screening and Management of Bacterial Vaginosis in Pregnancy. Sogc clinical practice guideline 2008 Aug;211:702-08. 3. Pramanik M, Kerkar SC, Salvi VS. Bacterial vaginosis:a cause of infertility? Int J STD AID 2009 Nov;20:778-81. 4. Guise JM, Mahon SM, Aickin M, Helfand M, Peipert JF, Westhoffc. Screening for bacterial vaginosis in pregnancy. Am J Prev Med 2001 Apr;20:62-72. 5. Nigro G, Mazzocco M, Mattia E, Carlo di Renzo G, Carta G, Anceschi MM. Role of infections in recurrent spontaneous abortion. J Matern Fetal Neonatal Med 2011 Aug; 24(8):983-89. 6. Nelson DM, Macones G.Bacterial Vaginosis in Pregnancy:Current Findings and Future Directions. Epidemiol Rev 2002;24:102-08.DOI:10.1093/epirev/mxf008. 7 9 SIGNATURE OF THE CANDIDATE 10. REMARK OF THE GUIDE: Bacterial Vaginosis in pregnancy and its outcome is an understudied subject in India. The data evolved by this study will help to understand the magnitude of the problem and formulate preventive strategies. 11. 11.1 GUIDE DR. ANUP KUMAR SHETTY ASSOCIATE PROFESSOR DEPARTMENT OF MICROBIOLOGY FATHER MULLER MEDICAL COLLEGE- KANKANADY MANGALORE-575002 11.2 SIGNATURE 11.3 HEAD OF THE DEPARTMENT DR.B. REKHA PROFESSOR AND HOD DEPARTMENT OF MICROBIOLOGY FATHER MULLER MEDICAL COLLEGE, KANKANADY MANGALORE-575002 11.4 SIGNATURE 12. 12.1 REMARKS OF THE CHAIRMAN AND DEAN 12.2 SIGNATURE 8