CTRI Number |
CTRI/2024/03/064446 [Registered on: 19/03/2024] Trial Registered Prospectively |
Last Modified On: |
16/03/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Follow Up Study |
Study Design |
Other |
Public Title of Study
|
Maternal Opthalmic blood flow is used as a predictor of severe pregnancy induced hypertension. |
Scientific Title of Study
|
Maternal Opthalmic Artery Doppler at 19 to 23 + 0 weeks as a predictor of Pre-eclampsia - A Descriptive observational study. |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Sagarika N Swamy |
Designation |
Post Graduate |
Affiliation |
Jawaharlal Nehru Medical College |
Address |
Department of obstetric and gynecology,Jawaharlal Nehru Medical College ,KLE Dr Prabhakar Kore Hospital, ,Shivabasavnagar,Belagavi,Karnataka-590010
Department of obstetric and gynecology,Jawaharlal Nehru Medical College ,KLE Dr Prabhakar Kore Hospital, ,Shivabasavnagar,Belagavi,Karnataka-590010
Belgaum KARNATAKA 590010 India |
Phone |
9980420665 |
Fax |
|
Email |
drsgnarayanaswamy@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Sagarika N Swamy |
Designation |
Post Graduate |
Affiliation |
Jawaharlal Nehru Medical College |
Address |
Department of obstetric and gynecology,Jawaharlal Nehru Medical College ,KLE Dr Prabhakar Kore Hospital, ,Shivabasavnagar,Belagavi,Karnataka-590010
Department of obstetric and gynecology,Jawaharlal Nehru Medical College ,KLE Dr Prabhakar Kore Hospital,Shivabasavnagar,Belagavi,Karnataka-590010 Belgaum KARNATAKA 590010 India |
Phone |
9980420665 |
Fax |
|
Email |
drsgnarayanaswamy@gmail.com |
|
Details of Contact Person Public Query
|
Name |
DrMB Bellad |
Designation |
Professor |
Affiliation |
Jawaharlal Nehru medical college ,belagavi |
Address |
Department of obstetric and gynecology,Jawaharlal Nehru Medical College ,KLE Dr Prabhakar Kore Hospital, ,Shivabasavnagar,Belagavi,Karnataka-590010
Department of obstetric and gynecology,Jawaharlal Nehru Medical College ,KLE Dr Prabhakar Kore Hospital, ,Shivabasavnagar,Belagavi,Karnataka-590010
Belgaum KARNATAKA 590010 India |
Phone |
9448124893 |
Fax |
|
Email |
mbbellad@hotmail.com |
|
Source of Monetary or Material Support
|
Department of obstetric and gynecology,Jawaharlal Nehru Medical College ,KLE Dr Prabhakar Kore Hospital, Belagavi
|
Jawaharlal Nehru medical college, Belagavi |
|
Primary Sponsor
|
Name |
Sagarika N Swamyself |
Address |
Jawaharlal Nehru ,Medical College Belagavi-59100 |
Type of Sponsor |
Private medical college |
|
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 Sagarika N Swamy |
Jawaharlal Nehru medical college |
Department of obstetric and gynecology,Jawaharlal Nehru Medical College ,KLE Dr Prabhakar Kore Hospital, ,Shivabasavnagar,Belagavi,Karnataka-590010
Belgaum KARNATAKA |
7975534671
drsgnarayanaswamy@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
JNMC INSTITUTIONAL ETHICS COMMITEE |
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 |
Comparator Agent |
nil |
nil |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
35.00 Year(s) |
Gender |
Female |
Details |
1.singleton live gestation
2.Gestational age between 19 to 23+0 weeks
3.After obtaining informed written consent |
|
ExclusionCriteria |
Details |
1.Chronic hypertensive and gestational hypertension
2.Diagnosed congenital anomalies
3.Known case of Cardiac diseases
4.Known case of thromboembolic disorders on T.Ecospirin
5.Ocular conditions like infections,trauma ,tumors |
|
Method of Generating Random Sequence
|
|
Method of Concealment
|
|
Blinding/Masking
|
|
Primary Outcome
|
Outcome |
TimePoints |
To examine the potential value of opthalmic artery Doppler at 19 to 23weeks |
To examine the potential value of opthalmic artery Doppler at 19 to 23weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
To reduce the maternal morbidity and decide the plan of management |
19 to 23 weeks |
|
Target Sample Size
|
Total Sample Size="41" Sample Size from India="41"
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)
|
20/04/2024 |
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
|
Objective of the study To examine the potential value of maternal ophthalmic artery Doppler at
19 to 23 weeks 1.1 Introduction and Need for the study: •
The prevalence of pre-eclampsia 8-10% which is responsible
for maternal and perinatal morbidity
and mortality, therefore early prediction will help in reducing the morbidity
and mortality •
The ophthalmic artery
which is the first branch of internal carotid artery which is in turn a
branch of common carotid artery ,the
left common carotid arises from the arch of aorta and
right common carotid arises from the brachiocephalic trunk, therefore the
blood pressure
changes are reflected earlier on these branches of which ophthalmic artery
is easily accessible vessel for Doppler
assessment. •
In women with pre-eclampsia ,compared with normotensive
pregnant women ,there is
decrease in impedence to flow and increase in the flow
velocity
waveforms from the ophthalmic arteries.
Need for the study
•
There are many studies have reported that ophthalmic artery
Doppler has been a useful biomarker for
prediction of Pre-Eclampsia.
•
However the period of gestation was not defined as the
studies were done on three different groups with different period of gestation.
Therefore further studies are required to be done on larger population under a
defined range of gestational age. |