| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
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%) period. The clinical features of eclampsia includes include seizures or post ictal state, headache, headache usually frontal, generalised oedema, vision disturbances, amnesia and other mental status changes. It 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 |