| 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
|
|
|
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
|
|
|
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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