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临床试验/CTRI/2025/11/097661
CTRI/2025/11/097661尚未招募不适用

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

Raavi Dinesh Gayakwad1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年11月28日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
25
试验地点
1
主要终点
To access MRI Brain Screening findings in Eclampsia patients

研究概览

简要总结

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

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
Female

入选标准

  • Pregnant women with period of gestation beyond 20 weeks with diagnosis of Eclampsia and no previous history of epilepsy or other neurological diseases.

排除标准

  • 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.

结局指标

主要结局

To access MRI Brain Screening findings in Eclampsia patients

时间窗: 4 weeks

次要结局

  • To correlate with maternal & neonatal outcomes(4 weeks)

研究者

发起方
Raavi Dinesh Gayakwad
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Raavi Dinesh Gayakwad

Kaher,s Jawaharlal Nehru Medical College

研究点 (1)

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