| CTRI Number |
CTRI/2015/05/005788 [Registered on: 20/05/2015] Trial Registered Prospectively |
| Last Modified On: |
19/05/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Heart Dysfunction by 2D-Echocardiography in Pre-eclamptic and Eclamptic women vs normal pregnant women:A hospital based case control study
|
|
Scientific Title of Study
|
Diastolic Dysfunction by 2D-Echocardiography in Pre-eclamptic and Eclamptic women vs normal pregnant women:A hospital based case control study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrMBBellad |
| Designation |
M.S.(OBG) |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Obstetrics and Gynaecology
Jawaharlal Nehru Medical College
KLE University
Nehru Nagar,Belgaum
Belgaum
KARNATAKA
590001
India |
| Phone |
9448124893 |
| Fax |
|
| Email |
mbbellad@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MBBellad |
| Designation |
M.S.(OBG) |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Dr.M.B.Bellad
Professor
Department of Obstetrics and Gynaecology
Jawaharlal Nehru Medical College
KLE University
Nehru Nagar,Belgaum
Belgaum
KARNATAKA
590001
India |
| Phone |
9448124893 |
| Fax |
|
| Email |
mbbellad@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrMBBellad |
| Designation |
M.S.(OBG) |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Obstetrics and Gynaecology
Jawaharlal Nehru Medical College
KLE University
Nehru Nagar,Belgaum
Belgaum
KARNATAKA
590001
India |
| Phone |
9448124893 |
| Fax |
|
| Email |
mbbellad@hotmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KLE DrPrabhakar Kore Charitable Hospital |
| Address |
Jawaharlal Nehru Medical College
Nehru nagar
Belgaum
Karnataka
Karnataka |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrMBBellad |
Labour room in KLE Dr.Prabhakar Kore Hospital |
KLE Dr.Prabhakar Kore Hospital
Nehru Nagar
Belgaum
Belgaum
KARNATAKA |
9448124893
mbbellad@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Pre-eclamptic and Eclamptic patients, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
All singleton pregnant women without known medical disease willing to participate in the study |
|
| ExclusionCriteria |
| Details |
Known case of cardiac disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of Diastolic dysfunction in pre-eclamptic and eclamptic women compared to normal pregnant women by 2D-Echocardiography |
Diastolic dysfunction is assessed once a pregnant women is diagnosed with pre-eclampsia or eclampsia irrespective of period of gestation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation between diastolic dysfunction and cardiopulmonary complications |
It is observed that pre-eclamptic and eclamptic women are more prone to develop cardiopulmonary complications after 1yr |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
31/05/2015 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Treating pre-eclamptic and eclamptic women is areal challenge to even experienced obstetrician as they at risk of developing pulmonary edema due to diastolic dysfunction.Therefore identification of this diastolic dysfunction will assist in effective management of these pre-eclamptic and eclamptic women to prevent cardiovascular and pulmonary complications |