1. D R A M A N Y A D A V
J U N I O R R E S I D E N T ( S E C O N D A R Y D N B )
D E P A R T M E N T O F O B S T E T R I C S A N D
G Y N A E C O L O G Y
A CROSS-SECTIONAL DESCRIPTIVE STUDY OF
PAP SMEAR IN PREGNANT WOMEN SEEKING
HEALTH CARE IN A RURAL DISTRICT
Guide :
Dr Prathima K N
MS Obstetrics and Gynaecology
Consultant
Department of Obstetrics and Gynaecology
District Hospital,Chikkaballapur
2. Title: A CROSS-SECTIONAL DESCRIPTIVE STUDY
OF PAP SMEAR IN PREGNANT WOMEN SEEKING
HEALTH CARE IN A RURAL DISTRICT
Duration:12 months (July 2023 to June 2024)
Place of study : Department of Obstetrics and
Gynaecology,District Hospital Chikkaballapur
3. Introduction
Cervical cancer is one of the three most common
malignancies in pregnancy
Incidence of 0.8 to 1.5 cases per 10,000 births1 .
The course of disease and prognosis of cervical cancer
in pregnant patients are similar to non-pregnant patients.
Important cause of mortality in women worldwide
The burden of cervical cancer is still high in developing
countries like India.
4. The peak incidence of disease is found in women in
their third decade, which is also the time of the maximal
childbearing capacity
The survival chance of a person becomes better if the
cervical cancer is detected and treated at earlier stages
due to its long pre-invasive stage.6
Therefore, screening is important.
5. A gross cervical lesion may be observed or palpated at
any gestational age.
The ability to detect early neoplasia by physical
examination may be limited by normal pregnancy
associated with cervical changes such as ectropion,
stromal edema and ripening.
That’s why we need pap smear for accurate
identification of these lesion
6. Antenatal period is a time when women come
voluntarily to seek health care for pregnancy.
This opportunity should be utilized to down stage
cancer cervix by detection of pre-invasive lesions with
cytology who otherwise might not report for screening.
7. Review of Literature
Study - Agrawal P et al13 (2022)
A study to analysis the role of PAP test as a screening
tool for carcinoma cervix and to detect other
abnormalities in pregnant population.
200 women screened
26% had inflammatory smear
1% abnormal (1 ASCUS & 1 LSIL)
Conclusion: Clinicians should make every effort to
educate, counsil and screen pregnant women if they
have not had pap test in past.
8. Study- Niyaf N A et al15( (2021)
Papanicolaou smear in pregnant women : A prospective
study
Aim: To access the prevalence of abnormal pap smear in
pregnancy and risk factors.
51.5% of pregnant women had abnormal pap smear. 1%
ASCUS, 1%LSIL
More in patients from rural background,lower class and
illiterates
Conclusion: Pregnant women seeking Obstetricians for
ANC visits must be screened for possible pre invasive
lesion of cervix (opportunistic screening)
9. Study by Ahuja R et al16 (2020)
A cross-sectional study to determine the awareness of pap
smear as a cervical cancer screening test in antenatal
women: to determine the incidence of cervical neoplasia
and premalignant lesions of the cervix in antenatal women.
308 women underwent a pap smear in their 1st trimester.
3(0.9%) abnormal smear (2 LSIL and 1 ASCUS). 31.2%
had inflammatory smears.
Conclusion: The antenatal period should be utilized as an
opportunity to screen women for cancer cervix.
10. Study - Priya S.S. et al18(2018)
A study to assess the incidence of Pap smear abnormalities
among antenatal woman presenting to hospital.
26% of the subjects had inflammatory changes
1% abnormal (1 ASCUS and 1 LSIL)
Lower age at marriage (<20 years) was found to be
associated with higher incidence of inflammatory changes
in the cervix.
They concluded that clinicians should make every effort to
educate, counsel and screen pregnant women if they have
not had a Pap test in the past.
11. Need of the Study
There is limited data on pap smear in pregnancy from
rural part of India which usually have more risk factors,
less knowledge about screening .
So our study aim to cover that population .
12. Aim and Objective
AIM & OBJECTIVE: To assess the prevalence of
abnormal papa smear in pregnant women and its
associated risk factors
13. Methods
PLACE OF STUDY: Department of obstetrics and
gynaecology, District Hospital chikkaballapur
STUDY DURATION: 12 months (July 2023 to June
2024)
STUDY DESIGN: Hospital based Cross-sectional
Descriptive study
14. SAMPLE SIZE : 200
Considering the prevalence of 8% of abnormal smear in
pregnancy and 4% allowable error at 95% confidence
level and 5% of level of significance, the sample size
calculated to be 200.21
Hence, 200 pregnant women will be enrolled in the
study who fulfilled the criteria mentioned below.
n= Z2 P(1-P) / d2
n= sample size
Z= statistic corresponding to level of confidence P=
expected prevalence
d= preccision
15. INCLUSION CRITERIA
All pregnant women upto 28 weeks of gestation who
came for their first antenatal check up.
EXCLUSION CRITERIA
Threatened abortion
Active Vaginal Infection.
History of sexual intercourse in the past 48 hours.
History of vaginal medication and douching in the past
48 hours.
Pregnant women who are not willing for Pap smear.
16. METHODOLOGY:
Informed written consent will be obtained from all the
study subjects.
Proforma obtained as per annexure I
Conentional Pap smear will be taken and sent for
histopathology
17. Statistical analysis:
Data analysis will be done using statistical package
for social science(SPSS) latest version.
Categorical data will be presented as proportions
and compared using chi square test
All statistical analysis will be done at 95%
confidence interval and P value of <0.05will be
considered as statistical significant
18. Case proforma(Annexure I)
Case number- Name: Age:
I.P.NO:
Residence : Rural / Urban
Age at marriage (years):
Education Status:
Socioeconomic Status:
Knowledge about Cervical Cancer Screening: Yes/No
19. Clinical details:
Gestational Age:
Gravida: Primi/Multi
History of Abortion:
History of Pre-term Delivery:
Family History of Cervical Cancer :
Maternal comorbidity like DM / HTN / Hypothyroidism
(if any):
20. On Examination:Pulse: Temperature:
Heart rate: Respiratory rate:
Per Abdomen :
Per Speculum Examination: Normal/Erosion/Discharge.
Adequacy of Smear: Adequate/ Inadequate
PAP Smear Report:
Investigations:
Complete blood Count(CBC)
21. Informed Consent(English)(Annexure IIA)
Title of the Project: : A CROSS-SECTIONAL
DESCRIPTIVE STUDY OF PAP SMEAR IN
PREGNANT WOMEN SEEKING HEALTH CARE
IN A RURALDISTRICT
Name of the Principal Investigator: Dr Aman Yadav
Contact: 9560034644
Patient’s Name:
Age:
Address:
22. I have received the information sheet on the above study
and have read and understood the written information.
I have been given the chance to discuss the study and
ask Questions which have been answered satisfactorily.
I consent to take part in the study, and I am aware that
my Participation is voluntary. I understand that I may
withdraw at any time without this affecting my future
care
23. I understand that the information collected about me
from my participation in this research and sections of
any of my medical notes may be viewed a by
responsible persons (ethics committee
members/regulatory authorities).
I give permission to these individuals to have access to
my records
Signature/Thumb Impression of subject: Name (in
capitals):
Signature of impartial witness Name (in capitals):
Signature of person conducting procedure
Name (in capitals):
Date:
Place:
24. Informed Consent (Kannada)(Annexure IIB)
TITLE –: A CROSS-SECTIONAL DESCRIPTIVE
STUDY OF PAP SMEAR IN PREGNANT WOMEN
SEEKING HEALTH CARE IN A RURALDISTRICT
ರೋಗಿಯ ಮೊದಲಕ್ಷರಗಳು:
ವಯಸ್ಸು :
ಲಿಂಗ: ಿಳಾಸ:
ಆಸಪ ತ್ರ
ೆ ಯ ಹೆಸರು: ನೋಿಂದಣಿ
ಸಂಖ್ಯೆ .:
ವೈದೆ ರ ಹೆಸರು:
ನಾನು ಮೇಲನ ಅಧ್ೆ ಯನದ ಮಾಹಿತಿ ಹಾಳೆಯನುು
ಸ್ವ ೋಕರಿಸ್ದ್ದ ೋನೆ ಮತ್ತ
ು ಲಖಿತ ಮಾಹಿತಿಯನುು ಓದಿದ್ದ ೋನೆ
ಮತ್ತ
ು ಅರ್ಥಮಾಡಿಕಿಂಡಿದ್ದ ೋನೆ.
ಅಧ್ೆ ಯನದ ಕುರಿತ್ತ ಚರ್ಚಥಸಲು ಮತ್ತ
ು ತೃಪ್ತ
ು ಕರಿಗಿ
ಉತ
ು ರಿಸ್ರುವ ಪ್
ೆ ಶ್ನ
ು ಗಳನುು ಕೇಳಲು ನನಗೆ ಅವಕಾಶ
25. ನಾನು ಅಧ್ೆ ಯನದಲ
ಿ ಪಾಲ್ಗೊ ಳ
ಳ ಲು ಸಮಮ ತಿಸ್ಸತ್ರ
ು ೋನೆ
ಮತ್ತ
ು ನನು ಭಾಗವಹಿಸ್ಸವಿಕೆಯು ಸವ ಯಂಪ್
ೆ ೋರಿತಿಗಿದ್
ಎಿಂದು ನನಗೆ ತಿಳಿದಿದ್.
ಇದು ನನು ಭವಿಷ್ೆ ದ ಕಾಳಜಿಯ ಮೇಲೆ ಪ್ರಿಣಾಮ
ಬೋರದಂತ್ರ ನಾನು ಯಾವುದೇ ಸಮಯದಲ
ಿ
ಹಿಿಂಪ್ಡೆಯಬಹುದು ಎಿಂದು ನಾನು
ಅರ್ಥಮಾಡಿಕಿಂಡಿದ್ದ ೋನೆ.
ಈ ಸಂಶೋಧ್ನೆಯಲ
ಿ ನನು ಭಾಗವಹಿಸ್ಸವಿಕೆಯಿಂದ
ನನು ಬಗೆೊ ಸಂಗ
ೆ ಹಿಸ್ದ ಮಾಹಿತಿ ಮತ್ತ
ು ನನು ಯಾವುದೇ
ವೈದೆ ಕೋಯ ಟಿಪ್ಪ ಣಿಗಳ ವಿಭಾಗಗಳನುು ಜಿಬ್ದದ ರಿಯುತ
ವೆ ಕ
ು ಗಳು (ನೈತಿಕ ಸಮಿತಿ ಸದಸೆ ರು/ನಯಂತ
ೆ ಕ
ಅಧಿಕಾರಿಗಳು) ವಿೋಕ
ಿ ಸಬಹುದು ಎಿಂದು ನಾನು
ಅರ್ಥಮಾಡಿಕಿಂಡಿದ್ದ ೋನೆ.
26. ವಿಷ್ಯದ ಸಹಿ/ಹೆಬ್ಬೆ ರಳಿನ ಅನಸ್ಕೆ:
ಹೆಸರು (ದೊಡಡ ಕ್ಷರಗಳಲ
ಿ ):
ದಿನಾಿಂಕ:
ನಷ್ಪ ಕ್ಷಪಾತ ಸಾಕ
ಿ ಯ ಸಹಿ ಕಾಯಥವಿಧಾನವನುು
ನಡೆಸ್ಸವ ವೆ ಕ
ು ಯ ಸಹಿ ಹೆಸರು (ದೊಡಡ ಕ್ಷರಗಳಲ
ಿ ):
ಹೆಸರು (ದೊಡಡ ಕ್ಷರಗಳಲ
ಿ ):
ದಿನಾಿಂಕ:
27. Patient information Sheet
Title: A cross sectional descriptive study of pap smear
in pregnant women seeking health care in rural
district
1. What is the background and purpose of the study?
We will be studying pap smear in pregnancy to rule
out cervical cancer
2. Why have I been chosen?
Because early diagnosis will help in early
management of cervical cancer
3. Do I have to take part?
You are free to decide whether you want to participate
in this study. If you do not wish to participate you will
not be included in this study. Also you will continue
to get the medical treatment without any prejudice.
28. 4. What will happen to me if I take part?
We will get to know about the early diagnosis of
cervical cancer
5. What are the benefits of taking part?
You will receive appropriate management for cancer
cervix
6. Will my taking part in this study be kept confidential?
Your participation in the study and the study records
relating to you will be kept confidential throughout
the study and thereafter. Your personal identity will
not be revealed in case of publication in any journal or
analysis of your results, nor will it be shared with
anyone.
29. 7. What are the possible risks, side effects and
discomforts of taking part?
Since the pap smear are collected, you may
experience either minor or no discomfort.
8. What will be the cost of taking part?
No, the participation is absolutely free of cost.
9. Will there be provision for treatment of research related
injury?
Although no study related injury to you is expected, in
case anything happens appropriate treatment for the
same will be provided free of cost as per the
Institutional policy.
30. 10. Whom should I contact if I need more information or
help?
You may contact any one of the below mentioned
investigators
1. Dr. AMAN YADAV Tel. No: 9560034644
2. Dr. PRATIMA Tel. No:9742571573
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3. ICO Information Centre on HPV and Cancer. Human
Papillomavirus and Related Diseases in India (Summary
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