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CTRI Number  CTRI/2025/12/098386 [Registered on: 03/12/2025] Trial Registered Prospectively
Last Modified On: 02/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Assessment of maternal cardiac dysfunction using 2D echo in preeclampsia- one year observational study at KLES Prabhakar Kore hospital 
Scientific Title of Study   ASSESSMENT OF MATERNAL CARDIAC DYSFUNCTION IN PREECLAMPSIA USING 2D ECHOCARDIOGRAPHY: ONE YEAR CROSS SECTIONAL STUDY AT KLES PRABHAKAR KORE 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  Vagisha Singh 
Designation  MBBS, Post Graduate in MS Obstetrics and Gynaecology 
Affiliation  Jawaharlal Nehru Medical College, Belagavi 
Address  G-1 Labour room, Departement of Obstetrics and Gynaecology, KLES Dr. Prabhakar Kore Hospital and Medical Research Centre, JNMC, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  7007106437  
Fax    
Email  vagisha6598@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Yashita Pujar 
Designation  MBBS, Post Graduate in MS Obstetrics and Gynaecology 
Affiliation  Jawaharlal Nehru Medical College, Belagavi 
Address  G-1 Labour room, Departement of Obstetrics and Gynaecology, KLES Dr. Prabhakar Kore Hospital and Medical Research Centre, JNMC, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9448142989  
Fax    
Email  yvpujar@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Vagisha Singh 
Designation  MBBS, Post Graduate in MS Obstetrics and Gynaecology 
Affiliation  Jawaharlal Nehru Medical College, Belagavi 
Address  G-1 Labour room, Departement of Obstetrics and Gynaecology, KLES Dr. Prabhakar Kore Hospital and Medical Research Centre, JNMC, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  7007106437  
Fax    
Email  vagisha6598@gmail.com  
 
Source of Monetary or Material Support  
KLES Prabhakar Kore hospital Belagavi Karnataka India 590010 
 
Primary Sponsor  
Name  Vagisha Singh 
Address  Jawaharlal Nehru Medical College, Belagavi, Karnataka- 590010 
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 Vagisha Singh  KLES Dr Prabhakar Kore Hospital and Medical Research Centre,JNMC Belagavi  G-1 Labour room, Departement of Obstetrics and Gynaecology, KLES Dr. Prabhakar Kore Hospital and Medical Research Centre, JNMC, Belagavi
Belgaum
KARNATAKA 
07007106437

vagisha6598@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: O149||Unspecified pre-eclampsia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Diagnosed with pre-eclampsia (BP ~140/90 mmHg with proteinuria or evidence of organ dysfunction)
Singleton pregnancy
Gestationa1 age~ 20 weeks
Willing to participate and provide informed consent 
 
ExclusionCriteria 
Details  Known pre existing cardiac disease
Chronic HTN
Eclampsia
Mulitple gestation
Gestational Diabetes
Unable/ Unwilling to undergo echocardiography 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess cardiac dysfunction in women with Preeclampsia by using 2D echocardiography  20 weeks to 42 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary objective-
To correlate severity of cardiac dysfunction with maternal outcome  
20 weeks to 42 weeks 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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)   23/12/2025 
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   Introduction-
Preeclampsia affects 2–7% of pregnancies and increases the risk of long-term heart disease. It often leads to diastolic dysfunction, followed by systolic issues. Echocardiography shows structural and functional heart changes. Early-onset cases cause more severe cardiac damage than late-onset. This study evaluates heart dysfunction in women with preeclampsia to guide prevention strategies.

Need for study-
Preeclampsia is a pregnancy-related hypertensive condition linked to lasting heart dysfunction. It affects both systolic and diastolic function, often continuing after childbirth. Echocardiography shows increased cardiac workload and left ventricular changes. More research using 2D echocardiography is needed to assess these effects. This study aims to evaluate heart function in preeclamptic women for better diagnosis and management.

Data collection procedure-
All pregnant women diagnosed with preeclampsia and admitted in labor room/obstetric ward will be screened and included in the study
Patients will be provided with consent form and will be explained about the study in a language best understood by them 
Informed written consent will be obtained after explaining the purpose, nature and process of study.
  Patient will be taken up for 2D echocardiography 
2D echocardiography findings will be taken for the study 
Antenatal and intra natal details will be noted 
 Maternal and fetal outcomes in term of morbidity and mortality will be noted.

 
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