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CTRI Number  CTRI/2021/08/036006 [Registered on: 27/08/2021] Trial Registered Prospectively
Last Modified On: 23/08/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Role of Maternal Ophthalmic artery Doppler in third trimester in prediction of pre-eclampsia 
Scientific Title of Study   Role of Maternal Ophthalmic artery Doppler at 34–37 weeks’ gestation in prediction of pre-eclampsia: Prospective study from single perinatal center 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Priyanka Paradkar 
Designation  Fetal medicine fellow 
Affiliation  Fernandez Hospital 
Address  Scan Reception desk, First floor, Fetal Medicine Department, Fernandez hospital unit 4, Opposite Toyota showroom, 3-5-874/1, Hyderguda-Basheerbagh road,Hyderguda

Hyderabad
TELANGANA
500029
India 
Phone  9004857096  
Fax    
Email  priyanshva@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Suseela Vavilala 
Designation  senior consultant, guide 
Affiliation  Fernandez Hospital 
Address  Reception, First floor, Fetal medicine department Fernandez hospital unit 4, Opposite Toyota showroom, 3-5-874/1, Hyderguda-Basheerbagh road,Hyderguda

Hyderabad
TELANGANA
500029
India 
Phone  9866611856  
Fax    
Email  drsuseela@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Priyanka Paradkar 
Designation  Fetal medicine fellow 
Affiliation  Fernandez Hospital 
Address  First floor, Fetal Medicine department, Fernandez hospital unit 4, Opposite Toyota showroom, 3-5-874/1, Hyderguda-Basheerbagh road,Hyderguda

Hyderabad
TELANGANA
500029
India 
Phone  9004857096  
Fax    
Email  priyanshva@gmail.com  
 
Source of Monetary or Material Support  
Fernandez Foundation and Research Institute 
 
Primary Sponsor  
Name  Fernandez Foundation 
Address  Fernandez Hospital unit4, Opposite Toyota Shawroom 3-5-874/1, Hyderguda Basheerbagh road,Hyderguda, Hyderabad,Telangana 500029 
Type of Sponsor  Research institution and hospital 
 
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 Priyanka Paradkar  Fernandez Hospital unit 4  Fetal medicine Department, First floor, Fernandez hospital unit 4,Opp Toyota Showroom, 3-5-874/1, Hyderguda-Basheerbagh Rd, Hyderguda, Telangana 500029
Hyderabad
TELANGANA 
9004857096

priyanshva@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Fernandez Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pregnant mothers between 34 to 37 weeks of gestation with absence of existing preeclampsia at the time of recruitment. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  1 . Singleton pregnancies between 34 to 37 weeks of gestation
2. Mothers who birth at Fernandez Hospital.
3. Structurally normal fetuses.
 
 
ExclusionCriteria 
Details  1. Multifetal pregnancies.
2. Loss to follow up.
3. Women with already established preeclampsia at the time of OAD examination
4. Gestational hypertension on treatment with tab Methyldopa.
5. Women with Ocular pathologies e.g. High Myopia(>-5.00 DS), Glaucoma ,Ophthalmic Artery occlusion or Ophthalmic artery Aneurysm.
6. Women with vasculopathies
7. Women with renal disorders causing hypertension or proteinurea.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
predictive value of PSV2/PSV 1 ratio of ophthalmic artery and development of preeclampsia or related complications.  between 34-37 weeks of gestation 
 
Secondary Outcome  
Outcome  TimePoints 
(i) To study the correlation of PSV2/PSV 1 ratio of ophthalmic artery with Demographic characteristics e.g.
• Age
• Height, Weight, BMI
• Parity
• Medical history of chronic illness
(ii) Association of OAD (PSV2/PSV1 ratio) with development of fetal growth restriction
 
between 34-37 weeks of gestation 
 
Target Sample Size   Total Sample Size="407"
Sample Size from India="407" 
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)   27/08/2021 
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="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)?  

Response - NO
Brief Summary  

Incidence of preeclampsia is 10% worldwide. More than 70% of preeclampsia occur at term. Maternal mortality from preeclampsia/eclampsia accounts for 63000 maternal deaths per annum worldwide, maximum being in low- middle income countries. Preeclampsia set in after 34 weeks of gestation is termed as late onset PE.(2) In late onset preeclampsia, cause is more likely an increasing mismatch between normal maternal perfusion and metabolic demands of the placenta and fetus, coupled with a maternal predisposition to inflammation, high BMI or high arterial pressure.(3) Considering the rising incidence of gestational hypertension, preeclampsia and PE associated comorbidity, various ways of early detection of risk of PE development in pregnancy are being researched all across the world since pasttwodecades.Mostofthemethodsfocusonthedetectionofearlyonsetpreeclampsiawhich constitute about 40-50% of the cases. More than 70% cases occur at term, if a screening method is introduced at 34 weeks, many mothers who are high risk for late onset preeclampsia can be detected early. Ophthalmic artery indices like PSV ratio, PI are being studied world wide at present.

The study conducted by Riskin Mashiah et al & Belfort et al (13,14) supported the evidence of development of PE is preceded by the decrease in the impedance to flow in the cerebral circulation. The ophthalmic artery, which is the first branch of the internal carotid artery has embryological, anatomical and functional similarities with the intracranial vasculature, is an easily accessible vessel for Doppler assessment that provides information on the less accessible intracranial circulation. Thus the use of Ophthalmic artery in prediction of PE is recently being investigated for its role in predicting preeclampsia worldwide and found to be beneficial.

We are proposing a Prospective observational study, to be conducted at Fernandez Hospital, Hyderabad  in the Department of Fetal Medicine, with 407 Study subjects. Patient population comprises of pregnant mothers visiting different branches of Fernandez Hospital for growth scan between 34 to37 weeks. Ophthalmic artery waveforms shall be obtained in sequence from the right eye, left eye and again from the right and then left eye. The following three indices will be used for analysis: first peak of systolic velocity; second peak of systolic velocity and the ratio of the second to first peak of systolic velocity (PSV ratio). Women will be then followed till their childbirth and details of mean arterial pressure at the time of OPD visits in third trimester, development of preeclampsia or eclampsia will be collected. Data about mode of delivery, development of fetal growth restriction shall be collected from the inpatient records. Entire data shall be analyzed.

 
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