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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.
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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.
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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
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