ERA’S LUCKNOW MEDICAL COLLEGE AND HOSPITAL, LUCKNOW

Department of Obstetrics And Gynecology

THESIS PROTOCOL

Clinico-microbiological profile Of Vulvovaginitis In Pregnant Women

Submitted for Approval by:

Dr. Romana Zameer, JR1
Dept. Of Obst. And Gynae
Session [2021-24]
 GUIDES
CHIEF GUIDE-
• Dr. Priti Vatsal
• Professor and Unit Head
• Dept. of Obst. And Gynae
• ELMCH, Lucknow

• CO-GUIDE-
• Dr. Ayesha Ahmad
• Associate professor
• Department of obstetric and gynaecology
• ELMCH,Lucknow

• CO-GUIDE-
• Dr.Priyanka
• Professor
• ELMCH,Lucknow
INTRODUCTION
• Vaginitis is the most prevalent disorder among the pregnant women.
• Vaginal symptoms are one of the most common reasons for gynecological
consultation.[1]
• Abnormal vaginal discharge (changes in quantity, colour and odour), may indicate
vaginitis. Vaginitis literally refers to a non-specific inflammation of vagina[2]
characterized by a watery discharge with burning and itching of the vulva.[3]
• The three most common causes of vaginitis are bacteria (bacterial vaginosis),
followed by fungi (candidiasis) and parasites (trichomoniasis).[4]
• Vaginitis causes different types of morbidity in women especially of reproductive
age group particularly during pregnancy resulting in sterility, abortion, and
stillbirth.[5,6]
• Since the disease leads to many complications, it is of the prime importance to
know the causative organisms, prevalence of the disease and its attributing
factors affecting the prevalence among women.
• The incidence of vaginitis during pregnancy increases more and more due to the
physiological changes in pregnancy.
• These changes include high levels of estrogen and progesterone hormones,
lowering of immunity of pregnant women, alteration of vaginal microbiome,
increased glycogen storage in vaginal cells and alteration in vaginal pH.
• Moreover poor hygiene, use of vaginal douching and sexual contact all
predispose to the high incidence of vaginitis during pregnancy.[7]
• This study is designed to estimate prevalence of vaginitis in pregnancy in the
enrolled patients.
 REVIEW OF LITERATURE
Author’s/Journal year Objectives Design Sam Methods Results
ple
size
Konadu DG et al. Prevalence of vulvovaginal To study the prevalence Cross 589 Vaginal swabs were The prevalence of
candidiasis,bacterial vaginosis,and of vulvovaginal sectional collected and vulvovaginal
trichomoniasis in pregnant women attending candidiasis (VVC), study samples analysed on candidiasis,bacteri
antenatal clinic in the middle belt of bacterial vaginosis (BV) wet mount and gram al
Ghana.BMC Pregnancy and and trichomoniasis (TV)
Childbirth.2019;19:341 in pregnant women. stain. vaginosis,trichomo
niasis were
36.5,30.9,&1.4%
respectively.
Dawood et al. Incidence and types of To determine the Cross 430 Vaginal swabs taken The incidence of
vaginitis in pregnant women attending incidence and types of sectional from posterior fornix bacterial
routine antenatal care at Tanta university vaginitis in pregnant study for bacteriological vaginosis,candidia
hospital: a cross sectional study.Int J women at early third and parasitological sis,trichomoniasis
Pregn & Chi Birth.2019;(2):87-90. trimester and impact of examination to were
vaginitis on pregnancy determine the type 20.16%,16.23%,&
outcome. and nature of 4.71% respectively
vaginitis.
Shreshtha S,NR Tuladhar et To find out the Cross- 200 Two high vaginal swabs 29.5% had
al.Prevalence of vaginitis among prevalence of common sectional taken from each candidiasis,52.6%
pregnant women attending Paropkar types of vaginitis study pregnant woman and had bacterial
Maternity and Women’s among pregnant amine test,wet mount vaginosis,& 1.3%
test,gram’s stain and
Hospital,Thapathali,Kathmandu,Nepal.N women. culture on SDA were had
epal Med Coll J 2011;13(4):293-296 performed. trichomoniasis.
 Author’s/journal year Objectives Design Sam Methods Results
ple
size
Yalew GT et al. Prevalence of To determine the Cross 422 Two vaginal swabs were The prevalence of
bacterial vaginosis and aerobic prevalence of sectional collected aseptically and wet Bv and AV among
vaginitis and their associated risk bacterial vaginosis study mount and gram’s stain test pregnant women
factors among pregnant women and aerobic was done. was 20.1% and
from northern Ethiopia:A cross
sectional study.PLoS ONE vaginitis and their 8.1%,respectively.
17(2):e0262692-2022 associated risk
factors among
pregnant women.

Pramoda Y.Prevalence of To know the Prospecti 200 Vaginal swabs sent to detect Prevalence of
vaginitis during pregnancy and prevalence of ve study BV by Nugent’s criteria, Bacterial vaginosis
its fetomaternal vaginitis in pregnant Amsel's criteria,Cadidiasis by was 81%,for
outcome.IAIM,2020;7(2):62-67 women KOH mount,gram staining, Candidiasis 14%
Trichomoniasis by wet mount and for
Trichomoniasis 5%

To evaluate the Cross 500 Vaginal swabs were collected Prevalence of

RavishankarN et
direct smear sectional from pregnant women and Candidiasis was
al.Antibiogram of bacterial microscopy and study were used for smear 27%,bacterial
culture and preparation and gram Vaginosis was
isolates from high vaginal
determination of staining and cultivation. 38.8%
swabs of pregnant women from bacteria from
vaginal discharge of
tertiary care hospital in
pregnant women.
Puducherry,India.Int.J.Curr.Micr
 Research Question
What is the clinico-microbiological profile of vulvo-vaginitis among pregnant women?
Aim of the study
To find out the clinico-microbiological profile of vulvo-vaginitis in pregnant women.
Objectives
1. To record the clinical profile of vulvovaginitis in pregnant women
2. To find out the proportion of pregnant women testing positive on vaginal smear or
culture for trichomoniasis,candidiasis,bacterial vaginosis and aerobic vaginitis.
 Methodology
• Type of study:Observational Cross sectional
• Location: Dept. Of Obst. And Gynaecology at Era’s Lucknow medical college
and hospital
• Duration: 24 months
• Study subjects: pregnant women

❑Inclusion criteria-
• All pregnant women.
 Methodology
❑Exclusion criteria-
• Labouring women
• Rupture of membranes
• Active Vaginal bleeding or history of bleed in preceding two weeks
• Patients receiving local or systematic treatments for vaginitis in the
current pregnancy.
 Procedure
• All pregnant women will have a per speculum examination.
• Vaginal swabs will be collected after informed written consent
and further processed for Wet Mount
examination/Staining(Gram)for Microscopy,Culture and
Sensitivity in Dept of Microbiology,ELMCH
• The samples will be evaluated for aerobic vaginitis,
trichomoniasis, candidiasis and bacterial vaginosis.
 Sample Size
Konadu DG et al. Prevalence of vulvovaginal candidiasis, bacterial vaginosis and trichomoniasis in pregnant women
attending antenatal clinic in the middle belt of Ghana. BMC Pregnancy and Childbirth. 2019;19:341

Formula used: n ≥ (p(1 -p))/(ME/zα)2

• Power of study= 90%
Where Zα is value of Z at two sided alpha error of 5%,
• Sample size= 95
ME is margin of error
• Margin of error: 10%
p is prevalence of at least one vaginal infection,
vulvovaginal candidiasis,
• Level of significance =
95
bacterial vaginosis and trichomoniasis

At least one vaginal infection: n>=((.564*(1-.564))/(.1/1.96)2=94.47=95(approx.)

Vulvovaginal candidiasis: n>=((.365*(1-.365))/(.1/1.96)2=89.04=90(approx.)
Bacterial vaginosis: n>=((.309*(1-.309))/(.1/1.96)2=82.02=83(approx.)
Trichomoniasis: n>=((.014*(1-.014))/(.1/1.96)2=5.30=6(approx.)
 Expected Outcome
• The study will find out the clinical and microbiological profile
of vulvovaginitis in pregnant women.
 INFORMED CONSENT FORM
I......................................................W/o............................................I am being asked to enroll in the study entitled “Clinico-microbiological
profile Of Vulvovaginitis In Pregnant Women” conducted by Dr Romana Zameer. I understand that my examination and or the test itself
does not involve any additional risk beyond the complication of any pre-existing disease and any financial compensation is not available.
I agree that my participation in the study is completely voluntary and that I may withdraw at any time without prejudicing my present or
future. I also understand that should my physician find if necessary and/or in the best of my interest, he/she may withdraw me from the study.
I understand that if I wish further information regarding my right as a research subject, I may contact the hospital administration. I also
understand that if I have any questions pertaining to my participation in the research study, I may contact the consultant.
I understand that my records may undergo review and inspection by the Era’s Lucknow Medical College & Hospital (Lucknow), or any donor
supporting this activity. All information collected in the study will be kept strictly confidential except as may be required by the laws. If any
publication results from the research, I will not be identified by name.
I have read and/or understand the consent form. I agree to participate in the research study (in case of illiterate participants: this form has
been read to me in my language & I understand about the study & am willing to take part in it.)

Name of Subject Signature of subject

Date (Thumb impression for illiterate participant)

Name of Investigator:
 सहमति पत्र

मुझे एरा के लखनऊ मेडिकल कॉलेज एंड हॉस्पिटल में डॉ …………………………… के अध्ययन के बारे में विस्तार से बताया गया है। प्रश्नावली के बारे में मुझे विस्तृत जानकारी
दी गई है। मुझे अध्ययन के जोखिम और लाभों के बारे में अवगत कराया गया है। इस अध्ययन के संबंध में सभी बिंदुओं के बारे में मुझे अपनी भाषा में विस्तार से बताया गया है और
मुझे प्रश्न पूछने का अवसर मिला और मुझे संतोषजनक उत्तर प्रदान किए गए। मैं स्वेच्छा से अध्ययन का एक हिस्सा होने के लिए अपनी स्वीकृ ति देता हूं और मुझे बताया गया है कि
मैं बिना कोई स्पष्टीकरण दिए कभी भी इस अध्ययन से बाहर निकल सकती हूं।
* अध्ययनकर्ता का रोगी / अभिभावक नाम एवं हस्ताक्षर
नाम एवं हस्ताक्षर
गवाह का नाम ……………………….
पता ……………………....
* हस्ताक्षर ……………………….
 ANNEXURE/PROFORMA
• Patient particulars:
• Name •Marital status
• Age •Education
• PID no. •Socioeconomic status
• Phone No. •POG
Present pregnancy:

• Itching in perineal area

• Dysuria, frequency
• Any treatment taken for UTI
• Discharge
• Dyspareunia
• Pain lower abdomen
• Fever
• Foul smell from vaginal area
• Use of medicated soap/
vaginal wash/ cream/powder
in perineal area
• DM
• Steroid use
Partner history:
• Multiple sexual partners
• Dysuria
• Fever
Previous history:
• Multiple sexual partners
• Contraceptive use
• Previous preterm labour
• Previous STI
• Previous Subfertility
• Previous treatment for vaginitis

• BMI
Local vulval examination
oInflammation of vulva
oCondition of vulval skin
oLabia
Speculum examination
oCervix:
oVagina:
oDischarge: color, consistency, quantity, smell
•Wet mount
•Gram stain
•Culture
REFERENCES
1.Owen MK, Clenney TL. American family physician: Vaginitis. J Amer Acad Family Physician. 2004;70:2125-
32.
2. Gillespie SH. Medical microbiology illustrated. Butterworth-Heinemann; 2014 Jun 28.
3. Kelcher A. Blackwell's Nursing Dictionary, 2nd edn..
4.Forbes B, Sahm D, et al. Diagnostic microbiology 12th Edition: Mosby Elsevier, St. Louis, MO. 2007:778-
81.
5. Hay PE, Lamont RF, et al. Abnormal bacterial colonisation of the genital tract and subsequent preterm
delivery and late miscarriage. Bmj. 1994 Jan 29;308(6924):295-8.
6. Wagh P, Bardeskar N, et al. Genital discharge, human papillomavirus screening and contraceptive use in
a tertiary care hospital in Mumbai, India. Indian Journal of Dermatology, Venereology, and Leprology. 2020
Sep 1;86(5):583-.
7. Anderson BL, Mendez-Figueroa H, et al. Pregnancy-induced changes in immune protection of the genital
tract: defining normal. American journal of obstetrics and gynecology. 2013 Apr 1;208(4):321-e1..
8.Konadu DG et al. Prevalence of vulvovaginal candidiasis, bacterial vaginosis and trichomoniasis in pregnant

women attending antenatal clinic in the middle belt of Ghana. BMC Pregnancy and Childbirth. 2019;19:341

9.Dawood et al. Incidence and types of vaginitis in pregnant women attending routine antenatal care at Tanta
university hospital: a cross sectional study.Int J Pregn & Chi Birth.2019;(2):87-90.

10.Shreshtha S,NR Tuladhar et al.Prevalence of vaginitis among pregnant women attending Paropkar Maternity and
Women’s Hospital,Thapathali,Kathmandu,Nepal.Nepal Med Coll J 2011;13(4):293-296

11.Yalew GT et al.Prevalence of bacterial vaginosis and aerobic vaginitis and their associated risk factors among
pregnant women from northern Ethiopia: A cross sectional study.PLoS ONE 17(2):e0262692

12. Pramoda Y.Prevalence of vaginitis during pregnancy ant its fetomaternal outcome.IAIM,2020;7(2):62-67

13.Ravishankar N et al.Antibiogram of bacterial isolates from high vaginal swabs of pregnant women from tertiary
care hospital in Puducherry,India.Int.J.Curr.Microbiol.App.Sci(2017)6(1):964-972
THANK YOU