1. Prevalence of Gynaecological morbidities in women of reproductive age
group
Department of Obstetrics And Gynecology
ERA’S LUCKNOW MEDICAL COLLEGE AND HOSPITAL, LUCKNOW
Submitting for approval by:
Dr. Shumaila Mansoor
Mobile no-9304849129
Email-ID: dr.shumailamansoor@gmail.com
Junior Resident
Course: M.S. Obstetrics and Gynecology
Dept. Of Obst. And Gynae
Session: 2022-2025
THESIS PROTOCOL
2. GUIDES
Chief Guide:
Dr.[Prof.] Uma Gupta
Professor and HOD
Dept. Of Obst. And Gynae
ELMCH, Lucknow
Email ID:umankgupta@gmail.com
Co-Guide:
Dr. Geeta Yadav
Assistant Professor
Dept. Of Obst. And Gynae
ELMCH, Lucknow
Email ID:geeta.yadav45@gmail.com
Co-Guide:
Dr. Ruby Khatoon
Professor
Dept. Of Community Medicine
ELMCH, Lucknow
Email ID:drrubykhatoon@gmail.com
3. INTRODUCTION
Gynaecological morbidity is defined as structural and functional disorder of
genital tract not related to pregnancy, delivery or puerperium.(1)
Gynaecological morbidities contribute to ill health, making up to one-third of
all deaths and disabilities among women of reproductive age and one-fifth of
the total ill health burden.(1)
Common gynaecological morbidities are menstrual disorders, genital prolapse,
abnormal vaginal discharge, local perineal lesions, and infestations.
4. • Gynaecological morbidities are among the most common of
complaints and lead to considerable disability, physical, mental and
social stress, not to speak of the economic burden it causes on families
and individuals.
• Undiagnosed and untreated gynaecological problems at young age
may have physical and psychological consequences in later life.
5. AUTHORS`S/
JOURNAL YEAR
OBJECTIVES DESIGN SAMPLE SIZE METHODS RESULTS
Mathur M et al.
Common
gynecological
morbidities among
married women in a
resettlement colony
of East Delhi. Int J
Reprod Contracept
Obstet Gynecol.
2017 Dec;
6(12):5330-5335
To study the
magnitude and
pattern of common
gynaecological
morbidities among
married women(18-
49 years) residing
in a resettlement
colony of East
Delhi.
Cross-sectional
study
1214 Self-designed,
Pretested
questionnaire
was used to
collect data.
59.5% subjects
had one or more
symptoms
related to
common
gynaecological
morbidities ;
commonest
symptom was
dysmenorrhoea
(34.5%)
REVIEW OF LITERATURE
6. AUTHORS`S/
JOURNAL YEAR
OBJECTIVES DESIGN SAMPLE SIZE METHODS RESULTS
Bhattacharyya N,
Dasgupta D and
Roy S et al.
Concomitants of
Gynaecological
Problem: A Study
on Young Married
Women of Rural
West Bengal.
Journal of the
Anthropological
Survey of India
2020 69(I) 124-
144
To study the
prevalence of
gynaecological
problem and its
concomitants and
management
among young
married women
living in rural
West Bengal.
Cross-
sectional
study
1107 Data collected
using pretested
schedule/
questionnaire and
focussed group
discussion.
40% subjects had
atleast one of the
gynaecological
problems
15.8% subjects had
more than one type of
gynaecological
problems. The most
frequent symptom was
excess vaginal
discharge.
7. AUTHORS`S/
JOURNAL YEAR
OBJECTIVES DESIGN SAMPLE SIZE METHODS RESULTS
Ojifinni OO, Ige
OK , Popoola
OA, Asuzu MC et
al. Prevalence
and Correlates of
Reproductive
Morbidity among
Female Traders
in Ibadan
Nigeria.Journal
of Community
Medicine and
Primary Health
Care. March
2020 32(1) 87-
102
To study the
prevalence and
correlates of
reproductive
morbidity among
female traders of
reproductive age
in Ibadan,
Nigeria.
Cross-
sectional
study
410 Data collected with
interviewer-
administered
structured
questionnaires.
91.8% subjects had
reproductive
morbidity
79.9%subjects had
gynaecological
morbidities with
menstrual problems
being the
commonest.
8. RESEARCH QUESTION
What will be the distribution of common gynaecological morbidities in women
of reproductive age group?
AIM
To find out the common gynaecological morbidities in women of reproductive
age group.
OBJECTIVES
1. To calculate the proportion of women suffering from gynaecological
morbidities in reproductive age group.
2. To calculate the relative percentage of different gynaecological morbidities.
9. METHODOLOGY
• Type of study: Cross-sectional study.
• Location: Department Of Obstetrics And Gynecology at Era’s Lucknow
Medical College and Hospital and UHTC,RHTC and CAMP attached with
ELMC & H.
• Duration: 24 months
• Study subjects: Women of reproductive age group between 18-49 years.
10. • Inclusion Criteria-
❑ Women of reproductive age group (between 18-49 years )
❑ Non-pregnant women
❑ Termination of pregnancy atleast 6 months before
• Exclusion Criteria-
❑ Pregnant women
11. METHODOLOGY
All women of reproductive age group who fulfill the inclusion criteria and exclusion criteria and
willing to participate in the study will be interviewed.
Data for study will be collected using a semi-structured questionnaire which will be designed and pre-
tested to collect information on socio-demographic profile, reproductive profile, common
gynecological morbidities and treatment seeking behavior.
The Proforma will include:
• Socio-Demographic Profile
• Clinical history and relevant general examination
• Gynecological examination-Per Speculum, Per Vaginal and Per rectal
examination as relevant
• Microbiological investigations: Urine Routine Microscopic Examination and
Culture Sensitivity, High Vaginal Swab, PAP Smear as relevant.
12. SAMPLE SIZE
Sample size is calculated on the basis of prevalence of gynaecological morbidities
in the study population using the formula
Where p = 59.5% expected prevalence of gynecological morbidities in the study
population
(Ref. number 3)
q = 100 – p ,
Type I error α=5 %, for the significance level of 95%.
Allowable error L = 5% absolute for detecting the results with 90% power of study.
Appropriate statistical tool will be applied to the obtained and observed data
using SPSS software version 29
The minimum sample size required n = 370
13. EXPECTED OUTCOME
•This study will find out the distribution of Gynaecological
morbidities in women of reproductive age group
(between 18-49 years)
14. Informed Consent Form for Research
Era’s Lucknow Medical College & Hospital,
Era University, Lucknow
(Part I: Subject Information Sheet)
Introduction:
I am Dr. Shumaila Mansoor, Junior Resident in the Department of Obstetrics And Gynecology Era’s
Lucknow Medical College & Hospital, Lucknow. I'm doing research on "Prevalence of Gynaecological
morbidities in women of reproductive age group ‘’. I’m going to give you information and invite you to
be part of this research. You are free to decide whether or not you will participate in the research. Before
you decide you can talk to anyone you feel comfortable with about this research. There may be some
words that you may not understand, please ask me to stop as we go through the information and I will
take time to explain. If you have questions later, you can ask me or the Staff.
Participant Selection:
We are inviting all patients attending ELMC with Gynecological morbidities of reproductive age group
(18-49 years)
15. Voluntary Participation:
Your decision to participate in this study is entirely voluntary. If you choose not to
consent, all the services you receive at this hospital will continue and nothing will
change. You may also choose to change your mind later and stop participating even
if you agreed earlier, without penalty or loss of benefits and the services you receive at
the hospital will continue.
Description of the process:
I this study with describe details of intervention.
Amount of blood sample to be taken should be mentioned: in PIS in ml.
Costs and source of investigations, disposables, implants: and drugs/ contrast
media must be mentioned in the PIS-
Duration:
The research will take place over a period of two year.
16. Benefits :
1.We will find out the prevalence of different gynaecological morbidities in reproductive age group(18-49 years)
2.We will be able to assess the magnitude of gynaecological morbidities.
Confidentiality:
We will not be sharing the identity of those participating in the research and all the information collected will be
confidential. Any information about you will have a number on it instead of your name. It will not be shared with or
given to anyone except your doctor.
Right to refuse or withdraw:
You do not have to agree to take part in this research if you do not wish to do and it will not affect your treatment at
this centre in any way.
Whom to contact:
In case of any queries now or later you can ask any question to Dr. –Shumaila Mansoor even after the study has
started. If you want to ask questions later, you may contact
Dr.Shumaila Mansoor, Junior Resident,
Department of Obstetrics and Gynaecology, Era’s Lucknow Medical College &
Hospital, Sarfarazganj, Hardoi Road, Lucknow.
Mob no.-9304849129, Email: dr.shumailamansoor@gmail.com
17. (Part II: Informed Consent Form)
I have read the forgoing information, or it has been read to me. I have the opportunity to ask question about it and
any question that I have asked have been answered to my satisfaction.
I consent voluntarily to participate as participant in this research.
1.I understand that my participation is voluntary and that I am free to withdraw at any time, without giving any
reason, without my medical care or legal rights being affected. ( )
2.I understand that my identity will not be revealed in any information released to third party published. ( )
3.I agree not to restrict the use data or results that arise from this study provided such a use only for scientific
purpose. ( )
4.I have received a copy of signed patients information/informed consent. ( )
Name of participant: ………………………………………………..
Signature of Participant: ……………………………………………
Date: …………………..
If Illiterate:
I have witnessed the accurate reading of the consent form to potential participant, and the individual has had
the opportunity to ask question. I confirm that the individual has given consent freely.
Name of witness: ……………………………and thumb print of participant
Signature of witness: …………………………
Date: ………………………
18. Statement by researcher/ person taking consent:
I have accurately read out the information sheet to the potential participant, and to the best of my ability made
sure that the participant understands that the following will be done.
I confirm that the participant was given an opportunity to ask questions about the study, and the entire
questions asked by the participant have been answered correctly and to the best of my ability. I confirm that
the individual has not been forced into giving consent, and the consent has been given freely and voluntarily,.
A copy of this information sheet has been provided to the participant.
………………… ……………. ……………..
Name of patient Signature Date & Time
………………… ……………. ……………..
Name of Study Doctor Signature Date & Time
………………… ……………. ……………..
Name of witness Signature Date & Time
Comments:
19. सहमति पत्र
मुझे इराज लखनऊ मेडिकल कालेज एवं अस्पताल में होने वाले अध्ययन क
े बारे में डा0 शुमैला मंसूर द्वारा डवस्तार से
जानकारी दे दी गयी है। मुझे इस रोग क
े लक्षण एवं उससे सम्बन्धित जााँच एवं इलाज क
े बारे में डवस्तृत जानकारी दे दी गयी
है।मुझे जांच एवं दवाईयों क
े सेवन से होने वाले लाभ एवं दुष्पररणामों से अवगत करा डदया गया है। इस अध्ययन से नया ज्ञान
प्राप्त होगा जो मानव जाडत क
े डलए लाभप्रद होगा। मुझे इस शोध से सम्बन्धित सारे डबन्दुओं का सम्पूणण डववरण डमल गया है
और मुझे प्रशन पूछने का अवसर प्रदान डकया गया और सन्तोषजनक उत्तर डदए गए।
मैं स्वेच्छा से व सहषण इस अध्ययन में सन्धिडलत होने की मंजूरी देती हाँ।मुझे बता डदया गया है डक मैं जब चाहाँ डबना बताए इस
शोध अध्ययन से हट सकती हाँ।
अध्ययन कताण का नाम रोगी/अडभभावक का नाम एवं हस्ताक्षर
………………………………………. ..……………………………………………………
हस्ताक्षर………………………….
गवाह का नाम……………………….
पता ……………………..................
हस्ताक्षर……………………………….
22. Menstrual History- Obstetric History-
LMP- Married Life-
Menarche GPLA
Last 6 cycles: Last Child Birth
no. of days Infertility
no. of pads
type of pads
pain during periods
use of analgesics for pain relief
inter-menstrual bleeding
Coital history- General symptoms:
Contraception: ever used/ never used/ sometimes used Backache Palpitations-
Method of contraception Headache Chest Pain
Painful intercourse Abdominal Pain-
Vaginal dryness Giddiness
Post- coital bleeding Body Pain
Loss of apetite
23. Examination:
Height Pallor
Weight Icterus
BMI Cyanosis
BP Clubbing
PR Lymphadenopathy
Temp Oedema
Speculum examination: Local Examination:
Cervix Vulvitis
Vagina Mass/Swelling
Discharge Leukoplakia
Cystocele
Rectocele
Cervical descent
Vaginal examination: Breast examination:
Cervical motion tenderness
Uterine tenderness Microbiological examination:
Size of uterus
Consistency
Adnexa
Mobility of uterus
24. REFERENCES
1.World Health Organisation. Guidelines for the management of sexually transmitted infections,Switzerland;2004
https://apps.who.int/iris/bitstream/handle/10665/61306/WHO_MCH_90.4.pdf;jsessionid=C0023DDFD15A94E930F
7F6FAA6C930D0?sequence=1 (assessed on 25-05-2023)
2. Mathur M et al. Common gynaecological morbidities among married women in a resettlement colony of East
Delhi. International Journal of Reproduction, Contraception, Obstetrics and Gynaecology.2017 Dec;6(12):5330-5335
3. Bhattacharyya N, Dasgupta D and Roy S et al. Concomitants of Gynaecological Problem: A Study on Young
Married Women of Rural West Bengal. Journal of the Anthropological Survey of India 69(I) 124-144 2020
4. Ojifinni OO, Ige OK, Popoola OA, Asuzu MC et al. Prevalence and Correlates of Reproductive Morbidity among
Female Traders in Ibadan Nigeria.Journal of Community Medicine and Primary Health Care.32(1) 87-102,March
2020