From
Dr. L. Bhageerathi
Inservice Post-Graduate in Microbiology
Department of Microbiology
Mysore Medical College and Research Institute
Mysore
To
Registrar (Evaluation)
Rajiv Gandhi University of Health Sciences
Bangalore
THROUGH PROPER CHANNEL
Respected Sir,
Subject : Submission of Synopsis titled “INCIDENCE OF TRICHOMONAS VAGINALIS INFECTION IN FEMALES OF REPRODUCTIVE AGE GROUP AND ITS ASSOCIATION WITH OTHER SEXUALLY TRANSMITTED INFECTIONS”.
I am here by submitting the above titled synopsis (4 copies) of my dissertation topic for the M.D. course period in the department of Microbiology at MMC&RI Mysore. Kindly accept my synopsis and do the needful..
The same has been submitted through on-line submission to the Rajiv Gandhi University of Health Sciences, Bangalore.
Thanking you,
Yours faithfully,
(dr. L. BHAGEERATHI)
Forwarded to The Director and Dean, Mysore Medical College and Research Institute, Mysore for further needful action.
Professor and Head
Date : Department of Microbiology
Mysore Medical College
Place : Mysore and Research Institute
Mysore.
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
KARNATAKA, BANGALORE
ANNEXURE – II
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
1. / Name of the Candidate and Address / : / Dr. L. BHAGEERATHIINSERVICE Post Graduate student
department of microbiology
Mysore Medical college and Research Institute,
Mysore – 570 021.
2. / Name of the Institution / : / MYSORE MEDICAL COLLEGE, AND RESEARCH INSTITUTE, MYSORE
3. / Course of study and subject / : / M.D. (MICROBIOLOGY)
4. / Date of Admission to the Course / : / 09-08-2009
5. / Title of the Topic / : / INCIDENCE OF TRICHOMONAS VAGINALIS INFECTION IN FEMALES OF REPRODUCTIVE AGE GROUP AND ITS ASSOCIATION WITH OTHER SEXUALLY TRANSMITTED INFECTIONS
6. BRIEF RESUME OF THE INTENDED STUDY
6.1 NEED FOR THE STUDY
Trichomonas vagainalis is a motile flagellate protozoan parasite. It is most common non-viral STI called trichomoniasis.1 Trichomonas vaginalis was first observed by Donne in 1836 in vaginal secretions. It is also found in urethra, Bartholin’s glands and even in bladder in women and urethra, prostatic glands of men.2
Annual incidence is 170 million in cosmopolitan cities, in females it is about 5 -20% and in males 2 to 10%. For the ensuing decades, little attention was paid to this sexually transmitted infection (STI) and it was often considered merely a marker of risky behaviour.3
Trichomoniasis is linked to pelvic inflammatory disease and can increase one’s susceptibility to viruses such as herpes, human papillomavirus (HPV) and HIV.3 There is increased incidence of endometritis which has been implicated with this infection. Pharyngeal and respiratory infections in newborn, born to mothers with vaginitis due to Trichomonas vaginalis is another important manifestation of trichomoniasis.4
Trichomoniasis is seen increasingly with poor socio-economic status, poor access to healthcare, less education, sexual risk behaviour, multiple partners, old partners, with a history of substance use, sexual partner with trichomoniasis, women with douchal procedures, prior STI etc.3,5
Our institute is attached to 1800 bedded government hospital, in that 400 beds are obstetrics and gynaecology, Cheluvamba hospital. Which caters to generally low socio-economic group. Hence the present study is undertaken to know the incidence of Trichomonas vaginalis infection in females of reproductive age group and its association with other sexually transmitted infections. This information will definitely help in treatment of trichomoniasis, and prevention of complications like Pelvic Inflammatory Disease (PID), Premature Rupture Of Membranes (PROM), low-birth weight, infertility, etc,.5 this study will also highlight the importance of screening for other STIs.
REVIEW OF LITERATURE
· Ramanamma R. Christian Medical College, Vellore, India 1989. 500 women in the age group of 15-49 years were studied. The prevalence of trichomoniasis was 16%.6
· White MJ, Sadalla JK, Sandhya R, et al., Study April 2004. A total of 690 patients were enrolled. Four hundred twenty 61% patients tested positive for trichomoniasis by wet mount preparation and 270 (39%) tested negative. Of the 420 trichomonas infection positive patients, 41 (9.8%), tested positive for Neisseria gonorrhoea, 35 (8.3%) tested positive for Chlamydia trachomatis, 16 (3.8%) for both.7
Prasad JH, Sulochana A, Kurz KM, et al. June 2005 Study. A total of 451 women were enrolled in the study. 240 were symptomatic and 211 were asymptomatic. Among 240 symptomatics, 58 (13%) trichomoniasis, 8(2%) Chlamydia and 1 (0.2%) Syphilis, 0% Gonorrhoea, 8(2%) Hepatitis B.8
· Pol VDB, William JA, Orr DP. 2005 study. In a cohort of 268 sexually active adolescent women who provided weekly vaginal swabs, describe a 6% incidence of Trichomonas vaginalis in the year following a negative test and 30% recurrence of Trichomonas vaginalis in the year following a positive test.9
· Trigg GB, Kerndt PR, Aynalem G in 2008 study estimates annual incidence of 7.4 million cases. Prevalence is high ranging from 22% to 51%. Wet mount is the most commonly used method with an estimated sensitivity of 58%.1
· Jill S. Huppert study 2009. Wet mount has a sensitivity of 50-60% and specificity 100%. Using culture demonstrated high prevalence of 80% in the female partners of infected men and suggested lower prevalence of 14.60% in the male partners of infected women.3
6.3 AIMS AND OBJECTIVES
1. To know the incidence of trichomoniasis in symptomatic females of 15-45 years age group.
2. To know the association of Trichomonas vaginalis infection with other sexually transmitted infections, like syphilis, gonorrhoea, chlamydia trachomatis, HIV, Hepatitis B.
7. MATERIALS AND METHODS
7.1 Source of Data
The present study will be conducted on minimum 100 sexually active women between age group of 15-45 years coming with history of white discharge pervaginum (WDPV) to Cheluvamba Hospital attached to Mysore Medical College and Research Institute, Mysore. Specimen will be collected over a period of 12 months (January 2010 – December 2010).
Twenty five asymptomatic sexually active women in the reproductive age group of 15-45 years will be taken as control group.
7.2 METHOD OF COLLECTION OF DATA
Sample size
Study group comprises of minimum 100 symptomatic women between 15-45 years of age.
Control group comprises of 25 asymptomatic women between 15-45 years of age.
Informed consent will be taken.
Detailed history will be entered in the pro forma.
7.3 METHOD OF COLLECTION OF SPECIMENS
1. Collection and transport of specimens
The symptomatic women i.e., WDPV in the reproductive age group of 14-45 years attending the hospital will be explained about the study, after which consent will be obtained. Detailed clinical history will be entered in the pro forma. White discharge will be collected in a sterile leak proof wide necked container with cotton swabs.
The container is labelled and immediately transported to microbiology laboratory.
If wet mount is positive for Trichomonas vaginalis, two endocervial swabs will be collected to screen for gonorrhea , Chlamydia.
Blood (2ml) will be collected with aseptic precaution to screen for syphilis, HIV, Hepatitis B.
From control group vaginal swab will be collected.
2. Processing
a. Macroscopic : White discharge sample thus obtained will be examined for its colour and pH.5
b. Microscopic : Wet saline preparation of white discharge & vaginal swab will be observed for pus cells, epithelial cells and motile trichomonas vaginalis.5
Smears will be prepared to stain by Gram’s and Giemsa as per the standard procedure10
§ Endocervical swab: Two smears will be prepared from a swab and stained by Gram’s stain and Geimsa stain.10
§ Another swab will be used for the detection of Chlamydia trachomatis antigen using SD bioline Chlamydia kit, immunochromatogrpahic test as per manufacturer’s instructions.
§ Blood : Serum will be separated and tested for HIV antibody, RPR, HBsAg.
7.4 INCLUSION CRITERIA
· Women in reproductive age group with white discharge per vaginum.
· Asymptomatic women in reproductive age group will be taken as control group.
· The women who are positive for Trichomonas vaginalis will be taken up for further study.
7.5 EXCLUSION CRITERIA
· Symptomatic women less than 15 yrs and more than 45 yrs.
· The women who are negative for Trichomonas vaginalis will be excluded from the further study.
7.6 Does the study require any investigation / intervention to be carried out on animals / humans ? It so, describe briefly.
Yes. Vaginal swab , endocervical swab and blood sample will be obtained after informed consent.
7.7 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.6?
Yes (copy enclosed)
8. LIST OF REFERENCES
1. Trig GB, Kerndt PR, Aynalem G. Sexually transmitted infections and pelvic inflammatory disease in women. Med Clin N Am 2008; 92: 1083-1113.
2. Text book of Medical Parasitology Jan 2005 P. Chakraborty. 2nd edition, New Central Book Agency Ltd., Calcutta.
3. Jill S. Huppert. Current opinion in obst and gynaecology 2009; 21: 371-378.
4. Watt RM, Philip A, Wos SM, Sam GJ. Rapid assay for immunological detection of trichomonas vaginalis. Journal of Clinical Microbiology 1986; 24(4): 551-555.
5. Mandell’s, Douglas, Bennett’s. Principles and Practice of infectious diseases. 6th edition, Eds. Pennsylvania: Elsevier Churchil Livingstone; 2005, II, Pg. 3206-3208.
6. Ramanamma R. Prevalence of specified gynaecological disorders in selected groups of rural women. Christian Medical College, Vellore, India 1989.
7. White MJ, Sadalla JK, Sandhya R, Springer BS, Francis L, et al. Cow Is the presence of trichomonas vaginalis a reliable predictor of coinfection with Chlamydia trachomatis and / or Neisseria gonorrhoeae in female ED patients. American Journal of Emergency Medicine 2005; 23: 127-130.
8. Prasad JH, Sulochana A, Kurz KM, George V, Lalitha MK et al. Reproductive tract infection among young married women in Tmail Nadu, India. Guttmacher Fmaily Planning Perspectives 2005; 31(2).
9. Pol VDB, William JA, Orr DP. Prevalence, incidence, natural history and response to treatment of Trichomonas vaginalis infection among adolescent women. J Infect Dis 2005; 192: 2039-2044.
10. Mackie and McCartney.Practical medical microbiology. Eds. 14th edition, Elsevier publications, 2007, Pg. 796-798, 808-809.
Proforma
case no:
Topic : Incidence of Trichomonas vaginalis in females of reproductive age group
and its association with other sexually transmitted infection.
Name: Age:
Ip/Op no: Date:
Occupation: self/husband Annual
income:
Last menstrual cycle: last
delivery:
h/o Risk behaviour:
Clinical history:
On examination:
Local
General
External genitalia: CVS
Cervix:
RS
Lymph nodes:
Laboratory use only
Vaginal discharge/ swab
Macroscopy- color - pH-
Microscopy - Wet Mount –
Gram’s stain –
Giemsa stain –
Endocervical swab - Gram’s -
Geimsa –
C. trachomatis Ag test –
Blood – RPR –
HIV Ab –
HBs Ag –
Impression:
INFORMED CONSENT FORM
Topic title : Incidence of Trichomonas Vaginalis infection in females of Reproductive age group and its Association with other Sexually Transmitted Infections.
Principle Investigator : Dr. L. Bhageerathi
Guide : Dr. Anuradha K.
Associate Professor
Department of Microbiology
Mysore Medical College and Research Institute
Mysore
Location of study : Mysore Medical College and Research Institute
Mysore, Karnataka, India
MEDICAL INVESTIGATOR’S COMMITMENT
I, hereby state that the participant has been counseled about the implications of the study and all the details regarding the study and questionnaire have been explained to the candidate in English / Kannada languages as desired by the candidate and the participant has been given his / her free and informed consent for the study.
I, the post-graduate student will do everything possible to assure that the consent for the study session will be kept unapparent and confidential.
Date : Signature of the Student
Place :
[Dr. L. BHAGEERATHI]
9 / Signature of the candidate / [Dr. L. Bhageerathi]10 / Remarks of the guide
11 / Name and Designation of
(in block letters)
11.1 Guide / Dr. ANURADHA K. M.D.,
Associate Professor
Department of Microbiology
Mysore Medical College and Research Institute, mysore.
11.2 Signature of Guide
11.3 Head of the
Department / Dr. D. VENKATESHA, M.D.,
Professor and Head of the Department
Department of Microbiology
Mysore Medical College and Research Institute, Mysore.
11.4 Signature
12 / 12.1 Remarks of the Chairman and the Director and Dean
12.2 Signature
ETHICAL COMMITTEE CLEARANCE
2. / Name of the Candidate / : / Dr. L. BHAGEERATHI
3. / Subject / : / M.D. (MIcrobiology)
4. / Name of the Guide / : / Dr. ANURADHA K. M.D.,
Associate Professor
Department of Microbiology
Mysore Medical College and Research Institute, mysore.
5. / Approved / Not Approved
(If not approved, suggestion) / :
Superintendent Professor and Head
K.R. Hospital Department of Surgery
Mysore. K.R. Hospital, Mysore.
Superintendent Professor and Head
Cheluvamba Hospital Department of Medicine
Mysore K.R. Hospital, Mysore.
Law expert
DIREctor AND DEAN
Mysore Medical College and Research Institute
Mysore.
11