PG DEGREE (Batch 2020-21) SYNOPSIS FORMAT

PART A – GENERAL INFORMATION

1 Title of the Dissertation MATERNAL AND PERINATAL OUTCOME OF SEVERE

PREECLAMPSIA

2 A. Name of the Candidate

with mobile number and

email ID:

Dr.LANKA USHAKIRAN NAIDU

7893001161

ushakirannaidu07364@gmail.com

3 B. Name of the Institute: SHRI DHARMASTHALA MANJUNATHESWARA

COLLEGE OF MEDICAL SCIENCES AND HOSPITAL,

MANJUSHREE NAGAR,SATTUR, DHARWAD-580009

4 C. University Registration

Number:

20MPG064

5 D. Name of the programme

studying:

M.S.OBSTETRICS AND GYNAECOLOGY

6 E. University Program Code: 2.3.5

7 F. Year of Admission: AUGUST 1ST

,2020

8 G. Month and year of

appearing for final

examination

2023 MAY

9 H. Month and year of

submitting Dissertation

FEBRAURY 2023.

10 I. Name (s), Designation (s)

& Addresses of the guide

DR.VRINDA PATIL,

ASSOCIATE PROFESSOR,

and co-guide (s) with

mobile numbers and email

ID

DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY

9845350558

drpatilvrinda@gmail.com

11 A. State whether the study

is intradepartmental or

interdepartmental:

Intradepartmental

B. If the study is

interdepartmental:

i. Mention the names of

collaborating

departments

ii. Mention whether

consent has been

obtained from them

(Copy to be

Attached)

NOT APPLICABLE

12 Total funds required for

the study (in rupees):

-

13 Source of funding -

PART B – TECHNICAL DETAILS

1 Title of the dissertation MATERNAL AND PERINATAL OUTCOME OF SEVERE

PREECLAMPSIA

2 Introduction

A. Problem statement Hypertension in pregnancy constitutes the most common

medical

complication occurring in 5-10 % of all pregnancies of which

severe pre-eclampsia complicates 25% of all the cases. Majority

of the referrals in our hospital are of pre-eclampsia patients.

B. Rationale

Maternal and perinatal complications are seen in patients with

severe pre-eclampsia.The present study is undertaken to find out

the morbidity and mortality in the mother and the baby.

C. Novelty The study of the prevalence and the maternal and perinatal

outcome has not been studied previously in our hospital.

D. Expected outcome

and application

Maternal complications like eclampsia, abruption, postpartum

haemorrhage and HELLP syndrome may be seen,Perinatal

complications like IUGR, preterm births, NICU admissions are

common.

Early diagnosis and prompt treatment can prevent complications

associated with severe pre-eclampsia.

3 Research question(s) What is the maternal and perinatal outcome in patients with

severe pre-eclampsia.

What is the prevalence of severe pre-eclampsia in pregnant

women attending to our hospital.

4 Research hypothesis

(es), if any

Pre-eclampsia still remains a major problem in developing

countries.

It is one of the causes of maternal and perinatal morbidity and

mortality.

The prevalence of severe pre-eclampsia among all pregnant

women attending our hospital is 2%.

5 Objectives of the Study:

A. Primary

objective(s)

B. Secondary

objective(s)

To study the maternal and fetal outcome in severe pre

eclampsia..

To study the prevalence of severe pre-eclampsia among the

pregnant women attending to our tertiary care hospital.

6 1. Review of literature A prospective study conducted by U.Sujatha Patnaik et al from

May

2018 - April 2019.

Place of study: Government Victoria Hospital, Andhra Medical

College, Visakhapatnam.

Topic:Maternal and perinatal outcome in severe pre-eclampsia

Result: Total 120 women with severe pre eclampsia after 34

weeks

of gestation were included.

Out of 120 cases of severe pre eclampsia, majority (70%) were

in

the age group 20-30 years and 79.16% primigravida. Edema

(80.8%) was the most common presenting feature followed by

headache (40.8%) in present study. 56.6% of severe pre

eclampsia women were delivered vaginally and about

43.5% delivered by caesarean section, majority in view of failed

induction or non-progress of labour .Maternal complication like

PPH in 5.8%, eclampsia in 9.1%, acute renal failure in 0.83%,

HELLP syndrome in 0.83%, pulmonary edema in 1.66%, and

maternal deaths were seen in 1.66% of patients with severe

pre eclampsia. In our study low birth weight was seen in 80%

cases,

fetal growth restriction in 20% and intra uterine fetal demise in

5% in patients with severe pre eclampsia and perinatal mortality

seen in 12% cases.

2) Maternal and perinatal outcome in severe preeclampsia and

eclampsia Rajni Priyanka, Chitra Sinha,216.10.240.19,2019

Total 140 women with preeclampsia and eclampsia were

included in the study. Conclusion: A proper antenatal care,early

intervention and prompt treatment is required to reduce maternal

and perinatal outcome in selected patients.

3)Another study was conducted by Neha saxena et al in 2011.

Place of study: Department of Obstetrics and Gynaecology,

L.T.M.M.C. and L.T.M.G, Sion Hospital, Mumbai,

Maharashtra, India Topic: Maternal and perinatal outcome in

severe preeclampsia and eclampsia Result: Concluded that out of

150 cases of severe pre-eclampsia and eclampsia, majority

(69%) were between 20-30 years of age and 47% were

primigravida. We had 75 patients with convulsions on admission

and 75 with severe pre-eclampsia of whom 11 had convulsions.

Headache was most common complaint. Common mode of

delivery was caesarean sectionin 72 (48%) women, majority in

view of failed induction or non-progress. Maternal

complications were noted in 59% attributed to renal dysfunction,

postpartum hemorrhage, DIC, placental abruption, HELLP,

pulmonary edema,pulmonary embolism and renal failure. 4

maternal deaths were recorded.

7 2. Methodology

A. Study design A prospective observational study

B. Study participants

(human, animals or

Humans

both)

i. Inclusion criteria

ii. Exclusion criteria

iii. Withdrawal criteria,

if any (trial-related

therapy, follow-up

and documentation

are terminated

prematurely as it is

indicated to ensure

safety of the

participants)

iv. Rescue criteria, if

applicable (starting

symptomatic

therapy either to

control symptoms

of disease or to

overcome lack of

adequate efficacy of

the study drug or

placebo)

v. Number of groups

to be studied,

identify groups with

definition

i.All severe preeclampsia patients beyond 28weeks of gestation.

ii.Exclusion Criteria:

Severe preeclampsia in patients with gestational age less than

28 weeks.

Diagnosed Eclampsia patients.

Patients with chronic hypertension

Patients with renal insufficiency

Patients with auto immune disorders. Eg:SLE

iii.Nil

iv.Nil

Nil

C. Sampling

a. Sampling

population

b. Sample size

calculation

c. Sampling

technique

a. Patient who meets the inclusion criteria.

b. All patients attending our hospital and who meets the

inclusion criteria.

c. Simple random sample

D. Randomization

details (for

interventional

studies)- Intervention

details with

standardization

techniques (drugs /

devices / invasive

procedures /

noninvasive

procedures / others)

NIL

E. Ethical Clearance

from the Institution’s

Ethics Committee

Obtained? (Copy to

be Attached)

Ehics clearance has been obtained from Institutional Ethics

Committee of SDM College of Medical Sciences and Hospital,

Dharwad. Ref no:SDMCMS&H/ IEC: 65: 2021, dated: 19-02-

2021.

F. Study procedure

G. Data collection

methods including

settings and

periodicity

Statistical package for social sciences (SPSSversion.20) will be

used for data analysis Descriptive statistical study will be done

Calculated p value<0.05 will be considered significant.

H. List of statistical tests

to be used for data

analysis

Data will be analysed by statistical package for social science

I. If it’s a Clinical Trial:

Clinical Trials

Registry of India or

equivalent

registration number to

be mentioned

NIL

8 3. List risks and benefits of

the study

Early diagnosis and management, preventing complications/

Improved maternal and fetal outcome.

9 4. Relevant references for

the project

(Minimum 10,

Maximum 20) (in

Vancouver style)

LIST OF REFERENCES:

1. U. Sujatha Patnaik, G. Rama Devi, K. Anusha, A.V.N.

Suseela. Maternal and perinatal outcome in severe pre-

eclampsia. IAIM, 2019; 6(10): 43-49.

2. Severe preeclampsia and eclampsia: incidence, complications,

and perinatal outcomes at a low-resource setting, mpilo central

hospital, bulawayo, Zimbabwe int j womens health. 2017; 9:

353–357.

3. Saxena N, et al. Maternal and perinatal outcome in severe

preeclampsia and eclampsia. Int J Reprod Contracept Obstet

Gynecol., 2016 Jul; 5(7): 2171-2176.

4. Chattopadhyay S, Das A, Pahari S. Fetomaternal Outcome in

Severe Preeclamptic Women Undergoing Emergency Cesarean

Section under Either General Or Spinal Anesthesia. J Pregnancy.

2014;2014:325098.

5. The feto-maternal outcome of preeclampsia with severe

features and eclampsia in Abakaliki, South-East Nigeria

Leonard Ogbonna Ajah, Lucky Osaheni Lawani, Johnson,

Journal of clinical and diagnostic research: JCDR 10 (9), QC18,

2016

6. Breathett K, Muhlestein D, Foraker R, Gulati M. Differences

in preeclampsia rates between african american and caucasian

women: trends from the national hospital discharge survey. J

Womens Health (Larchmt) 2014;23(11):886–93.

7. Prabhakar G, Shinde MA, Jadhav CA. Clinical study of

eclampsia patients at DR. V M. Government Medical Collage

Solapur, India. IOSR Journal of Dental and Medical Sciences.

2015;13(7):10-6.

8. Fetomaternal outcome in cases of pre-eclampsia in a Tertiary

Care Referral Hospital in Delhi, India: a retrospective analysis

Alpana Singh, Sonia Chawla, Divya Pandey, Nusrat Jahan, Arifa

Anwar Int J Sci Stud 4 (2), 100-3, 2016

9. Minire A, Mirton M, Imri V, Lauren M, Aferdita M.

Maternal complications of pre eclampsia. Med Arch., 2013;

67(5): 339-41

10. Maternal and perinatal outcome in severe preeclampsia and

eclampsia Rajni Priyanka, Chitra Sinha,216.10.240.19,2019

10 5. Conflict of interest for

any other investigator(s)

(if yes, please explain in

brief)

No conflict of interest

11 6. Declarations/Remarks by

the Guide

Severe pre-eclampsia is a major cause of morbidity among the

pregnant women.This study will benefit both mother and baby in

terms of importance of good antenatal care,early detection of

high risk women and prompt referral to tertiary care and early

initiation of treatment.

SDM MEDICAL COLLEGE & HOSPITAL

CONSENT FORM

Patient’s statement

I voluntarily accept admission to the SDM MCH for the performance of the studies. The nature,

demands and hazards involved in these studies have been fully explained to me. I understand that

I may withdraw from these studies at any time for any reason. I confirm that I have passed my

eighteenth birthday, the required minimum age necessary to take part in an adult research study.

I consent to the release of scientific data resulting from my participation in this study to the

Principal Investigator for use by him for scientific purposes. The principal Investigator assures

my anonymity. I understand that the record of this experiment becomes part of my medical

record and is protected as a confidential document. I understand that this record will only be

available to physicians and investigators involved with this study. Other staff may be authorized

by the Head to review the record for administrative purposes or for monitoring the quality of

patient care.

In the unlikely event of physical injury resulting from participation in this research, I understand

that medical treatment will be available from the SDMMCH, including first aid, emergency

treatment and follow –up care as needed. However, no compensation can be provided for medical

care apart from the foregoing. I further understand that making such medical treatment

available, or providing it, does not imply that such injury is the fault of the investigator(s).I also

understand that by my participation in this study I am not waiving any of my legal rights. I

understand that in the case of any problem I can contact Dr (PROF).RATHNAMALA DESAI,

PRINCIPAL & DR (PROF). ASHA NERAVI Head of the Dept of Obstetrics and Gynaecology or

any member of the Institutional Ethical Review Board, SDM MEDICAL COLLEGE

DHARWAD.

Date: --------------------- Signature: ---------------------

Witness: ------------------- Name: ----------------------

Physician’s Statement:

I have carefully explained the nature, demands and foreseeable risks of the above studies to the

patient.

Date:_____________

Signature:__________________

PROFORMA

Case No: IP No. :

Name : Occupation :

Age : Religion :

Socioeconomic status: Address :

A.PRESENTING COMPLAINT

B. MENSTRUAL CYCLE

Cycles: Regular / Irregular

Flow: Moderate /Excessive

LMP:

EDD:

C.OBSTETRIC HISTORY:

Married life-

Obstetric score-

D. PAST HISTORY:

1.H/O previous blood transfusions

2. H/O previous surgery.

3. H/O T.B/DM/Hypertension.

E. FAMILY HISTORY:

F. PERSONAL HISTORY:

Diet Appetite

Bowel and bladder Habits

G. GENERAL PHYSICAL EXAMINATION

Pallor: Icterus:

Cyanosis: Clubbing:

Edema: Lymphadenopathy:

Temperature: Pulse:

Blood pressure: Respiratory rate:

H. SYSTEMIC EXAMINATION:

CVS –

RESPIRATORY SYSTEM:

CNS:

INVESTIGATIONS:

-Complete blood count

-Liver function test

-Renal function test

-Coagulation profile

-Fundoscopy

-Routine urine examination

-Fetal doppler

P/A:

P/V:

Maternal outcome:

1)Gestational age at delivery.

2)Clinical presentation

3)Complication:

-Eclampsia

-Abruption

-HELLP syndrome with DIC

-Pulmonary edema

-Acute renal failure

-Post partum haemorrhage

-ICU Admission

-Maternal death

4)Mode of delivery

5)Indication of caesarean section

Perinatal outcome:

1) IUGR

2) Preterm birth

3) Apgar score

4) NICU admission

5) Still birth

6) Intrauterine fetal death

7) Early neonatal death

Figure 1

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