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CTRI Number  CTRI/2025/11/097661 [Registered on: 18/11/2025] Trial Registered Prospectively
Last Modified On: 17/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   LONGITUDINAL 
Study Design  Other 
Public Title of Study   Role of MRI in Eclamptic patients and its relation with mother and baby outcomes in pregnancy. 
Scientific Title of Study   Role Of Neuroimaging (MRI Brain Screening) In Eclamptic Patients And It’s Correlation With Maternal And Neonatal Outcomes: One Year Longitudinal Observational Study In Tertiary Care Hospital 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Raavi Dinesh Gayakwad 
Designation  Post Graduate 
Affiliation  Kaher,s Jawaharlal Nehru Medical College 
Address  Chandraprabha, New Singhaniya Nagar, Near Susanksar Vidya Mandir School, arni road, Wadgaon, Yavatmal, 445001

Yavatmal
MAHARASHTRA
445001
India 
Phone  8329125103  
Fax    
Email  raavigayakwad@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Yeshita Pujar 
Designation  Professor and Head of department 
Affiliation  KAHERs JAWAHARLAL NEHRU MEDICAL COLLEGE 
Address  Sharada consulting centre, 9234, Nyaya marg, Shivbasava nagar, Belagavi, Karnataka, 590010

Belgaum
KARNATAKA
590010
India 
Phone  9448142989  
Fax    
Email  yvpujar@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  YESHITA PUJAR 
Designation  PROFESSOR and Head of department 
Affiliation  KAHERs JAWAHARLAL NEHRU MEDICAL COLLEGE 
Address  SHARADA CONSSULTING CENTRE, CTS 9234, Nyaya marg, Shivbasava nagar, Belagavi, Karnataka, 590010


KARNATAKA
590010
India 
Phone  9448142989  
Fax    
Email  yupujar@hotmail.com  
 
Source of Monetary or Material Support  
Kahers Jawaharlal Nehru Medical College And Dr. Prabhakar Kore Hospital, Belgavi, Karnataka 
 
Primary Sponsor  
Name  Raavi Dinesh Gayakwad 
Address  Chandraprabha, New Singhaniya nagar, near Susanskar Mandir School, Arni road, Wadgaon, Yavatmal, 445001 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Raavi Dinesh Gayakwad  KLEs Dr Prabhakar Kore Hospital and Medical Research centre, Belagavi   Second floor, Obgyn Department, Jnmc campus, NH service road, Nehru Nagar, Belagavi, Karnataka 590010
Belgaum
KARNATAKA 
08329125103

raavigayakwad@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O159||Eclampsia, unspecified as to timeperiod,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  Pregnant women with period of gestation beyond 20 weeks with diagnosis of Eclampsia and no previous history of epilepsy or other neurological diseases 
 
ExclusionCriteria 
Details  Pregnant women with known case of epilepsy or other neurological diseases
Pregnant women with chronic neurological conditions that may affect MRI findings
Pregnant women with MRI contraindications  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To access MRI Brain Screening findings in Eclampsia patients  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To correlate with maternal & neonatal outcomes  4 weeks 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/11/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

PROJECT TITLE:-

Role of neuroimaging (MRI brain screening) in eclamptic patients and it’s correlation with maternal and neonatal outcomes: One year longitudinal observational study in tertiary care hospital

INTRODUCTION:-

Eclampsia is a convulsive condition and the most severe manifestation of preeclampsia. It is defined as the new onset of tonic–clonic seizure activity (usually lasts 60–90min) and/or coma in the absence of other causative conditions. Eclampsia is a life-threatening obstetric emergency, characterized by seizure and/or consciousness disorders which cannot be related to another neurological disease in a woman with gestational hypertension or preeclampsia. Eclampsia is often insidious in onset and is characterized by hypertension, proteinuria, with or without oedema, associated with seizures either during pregnancy, in labour or within 6 weeks of delivery. Eclampsia can occur antepartum (35-45%), intrapartum (15-20%) or in post-partum (35-45%) periodThe clinical features of eclampsia includes include seizures or post ictal state, headache, headache usually frontal, generalised oedema, vision disturbances, amnesia and other mental status changesIt is one of the most common cause of maternal death. Recent studies using computed tomography (CT) and magnetic resonance imaging (MRI) help to better understand brain lesions that occur during an eclamptic fit. These lesions include intracerebral haemorrhage, cerebral ischemia, and cerebral oedema.

 The aim for Diagnostic MRI Brain Screening in patients of Eclampsia is to recognise and assess signs of any brain-related complications that may arise.

 Early identification of brain lesions can help us in early management which can lead to prevention of further neurological damage and improve case outcomes and recovery.

 

Objective of the study

 The primary objective of this study is to assess MRI Brain screening findings in eclampsia patients and to correlate with its clinical presentations

The secondary objective is to correlate with maternal and neonatal outcomes

 

Source of Data: Consenting Pregnant women of age 18 years to 45 years age, with no previous history of neurological diseases and with period of gestation beyond 20 weeks visiting KLE’s Dr. Prabhakar Kore Hospital and Research Centre, Belagavi, diagnosed with Eclapmsia


Study Design: Longitudinal observational study

Study Period: One year


Sample Size:

The sample size was estimated to assess the prevalence of abnormal neuroimaging findings (e.g., PRES, infarction, haemorrhage) in pregnant women with eclampsia. Based on the study by Kumari A et al. (IJRCOG, 2023), approximately 58% of eclamptic patients had pathological MRI findings. To estimate this proportion with a 95% confidence level and a margin of error (precision) of ±19.4%, the following formula was

Formula used for sample size calculation:

n =  Z2 . p . (1-p)

            d2

Where:

     Z=1.96 (for 95% confidence)

     p=0.58

   d=0.19

Hence, the minimum required sample size is 25.

We will include all eligible patients presenting over one year using convenience sampling. This approach is scientifically acceptable for a rare, time-bound condition and adequate for exploratory, hospital-based observational research.


Sampling technique: Convenience sampling


Inclusion Criteria:

·         Pregnant women with period of gestation beyond 20 weeks with confirmed diagnosis of  eclampsia and no previous history of any neurological diseases who are willing to consent

 

Exclusion Criteria:

·         Pregnant women with known case of epilepsy or previous/known history of any neurological diseases

·         Chronic neurological conditions that may affect MRI findings

·         MRI contraindications (e.g., metallic implants, claustrophobia)

 

Investigations required for this study:- MRI BRAIN SCREENING

 
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