| CTRI Number |
CTRI/2021/05/033524 [Registered on: 10/05/2021] Trial Registered Prospectively |
| Last Modified On: |
09/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Cardiac changes in pre-eclamptic women in pregnancy |
|
Scientific Title of Study
|
Evaluation of ventricular function by speckle tracking echocardiography in preeclamptic women |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ruthvika Kundoor |
| Designation |
Post graduate |
| Affiliation |
Kasturba Medical College |
| Address |
Room number 22
Division of Obstetrics and Kasturba medical college, Manipal, Udupi, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
9700810820 |
| Fax |
|
| Email |
ruthvikakundoor88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunanda Bharatnur |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College |
| Address |
Room number 22
Obstetrics and gynecology
Kasturba medical college, Manipal, Udupi, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
9700810820 |
| Fax |
|
| Email |
sunanda.somu77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ruthvika Kundoor |
| Designation |
Post graduate |
| Affiliation |
Kasturba Medical College |
| Address |
Room number 22
Division of Obstetrics and gynecology
Kasturba medical college, Manipal, Udupi, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
9700810820 |
| Fax |
|
| Email |
ruthvikakundoor88@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Obstetrics and Gynecology
Kasturba medical college Manipal.
Karnataka |
|
|
Primary Sponsor
|
| Name |
Kasturba medical college |
| Address |
Department of Obstetrics and Gynecology,
Kasturba Medical college
Manipal
Manipal. |
| 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 |
| Dr Ruthvika |
Kasturba medical college |
Room number 22,
Division of Obstetrics and Gynecology
Kasturba medical college Manipal
Udupi
KARNATAKA |
9700810820
ruthvikakundoor88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
26.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Singleton pregnancy atleast 28 weeks to 36 weeks of gestation, with diagnosis of preeclampsia according to ACOG |
|
| ExclusionCriteria |
| Details |
Multifetal gestation
Pre-exisiting cardiac disease.
Diabetes mellitus type 1 or 2.
Pre-existing pulmonary disease.
Gout, connective tissue, renal and hepatic disease.
Cervical incompetence.
Any fetal anomaly detected. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Left ventricular strain
Left ventricular strain rate |
At 28-32 weeks of pregnancy
6 weeks post partum |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
left ventricular strain
functions of ventricles |
28-32 weeks of pregnancy
6 weeks post partum |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
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)
|
14/05/2021 |
| 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="2"
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)?
Response - NO
|
|
Brief Summary
|
Preeclampsia is a multisystem disorder that can affect almost every organ. Cardiopulmonary morbidity is seen in significant proportion of preeclampsia cases. This study is mainly to test the ventricular function, strain and strain rate of the left and right ventricle, using speckle tracking echocardiography. Written and informed consent will be taken from the patient. Maternal characteristics like height, weight, BMI will be noted. General physical examination, baseline laboratory investigations and routine preeclampsia investigations will be sent. Patients will be categorized into mild and severe preeclampsia. Recruited patients will be examined in left lateral decubitus position using commercial ultrasound scanner from 24-36 weeks. Transthoracic echocardiography with Speckle tracking echocardiography using GE VIVID S60 2D echocardiographic system 1.3-4.5 Mhz 3Sc-RS adult probe. Standard views: parasternal long axis, short axis, 2,3,4 chamber view. LA,LV diameter and wall thickness to be measured using M mode echocardiography. Multidirectional analysis of LV global longitudinal strain (GLS) will be performed using 2D speckle tracking echocardiography by the apical 2,3,4 chamber views. LV is divided into 6 segments in each apical view. All the images will be recorded with frame rate of 50 frames per second. Left ventricular GLS will be derived from average of 6 segmental peak systolic strain values and Right ventricular global longitudinal strain from 3. Echocardiography will also be done 6 weeks post partum to assess if the cardiovascular changes are persistent or have any residual deficit or if they are returning to normal |