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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  
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 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  
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 
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. 

 
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