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
|
|
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
|
|
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. |