| CTRI Number |
CTRI/2021/10/037200 [Registered on: 08/10/2021] Trial Registered Prospectively |
| Last Modified On: |
08/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Role of measuring blood supply of eye with other biophysical markers at 19-24 weeks in detecting development of high blood pressure in pregnancy |
|
Scientific Title of Study
|
Role of Ophthalmic Artery Doppler in prediction of pre-eclampsia with biophysical markers at 19-24 weeks gestation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tseten Zangmu Bhutia |
| Designation |
Fellowship in fetal medicine |
| Affiliation |
Fernandez foundation |
| Address |
Trinity towers, Hyderguda, Old MLA quarters, near Fernandez hospital unit 4, Hyderabad.
Hyderabad
TELANGANA
500029
India |
| Phone |
7005456277 |
| Fax |
|
| Email |
tstnzangmu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suseela Vavilala |
| Designation |
Consultant fetal medicine |
| Affiliation |
Fernandez foundation |
| Address |
Fernandez hospital unit 4, Opposite Toyota showroom, Hyderguda.
Hyderabad
TELANGANA
500029
India |
| Phone |
7005456277 |
| Fax |
|
| Email |
drsuseela@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tseten Zangmu Bhutia |
| Designation |
Fellowship in fetal medicine |
| Affiliation |
Fernandez foundation |
| Address |
Trinity towers, Hyderguda, Old MLA quarters, near Fernandez hospital unit 4, Hyderabad.
Hyderabad
TELANGANA
500029
India |
| Phone |
7005456277 |
| Fax |
|
| Email |
tstnzangmu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Fernandez Hospital Foundation |
|
|
Primary Sponsor
|
| Name |
Fernandez Hospital Foundation |
| Address |
Hyderguda, Hyderabad |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Fernandez Hospital Foundation |
Hyderabad |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tseten Zangmu Bhutia |
Fernandez Hospital |
All rooms in Fetal medicine unit
Hyderabad
TELANGANA |
7005456277
tstnzangmu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
pregnant ladies |
| Patients |
(1) ICD-10 Condition: O149||Unspecified pre-eclampsia, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
•All singleton mothers booked before 24 weeks
•Mothers who birth at Fernandez Hospital
•Singleton pregnancies with structurally normal fetus between 19-24 weeks
•Population who are unscreened for preeclampsia in first trimester
|
|
| ExclusionCriteria |
| Details |
1.Pregnancies with aneuploidy and major fetal abnormality
2.Multifetal pregnancy
3.Miscarriage or fetal death before 26 weeks
3.Loss to follow up
4.Screened for pre-eclampsia in first trimester
5.Mothers with renal disease causing hypertension and proteinuria
6.Mothers with ocular/ ophthalmic artery pathologies using vasodilating drug
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To predict preterm PE (37 weeks) and term PE (≥37weeks) using Opthalmic artery doppler
|
After delivery and discharge from the hospital.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Preterm and term delivery and development of pre-eclampsia using Ophthalmic artery doppler, Uterine artery PI, mean arterial pressure. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="575"
Sample Size from India="575"
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)
|
08/10/2021 |
| 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
|
Screening and prevention of pre-eclampsia are major health goals of maternal healthcare worldwide. Apart from uterine artery, several peripheral vessel doppler indices have been investigated as a potential marker for the development of pre-eclampsia, among which Ophthalmic Artery Doppler is one among them. Objective of this study is to evaluate Ophthalmic Artery Doppler at 19-24weeks of gestation alone or in combination with biophysical markers (maternal factors, Uterine artery PI, mean arterial pressure) to predict pre-eclampsia and to see its predictive value for gestation age at birth. It would be a 1 year prospective observational study to be conducted in Fetal Medicine unit of Fernandez Hospital Foundation. All singleton mothers booked before 24weeks, fullfilling inclusion criterias during the study period will be enrolled for the study. Informed consent will be obtained at the time of screening. Recording of maternal demographic characteristics, medical history, mean arterial pressure will be recorded. Mid trimester anomaly scan, Uterine artery PI, Ophthalmic artery indices will be checked in a same scan setting. Ophthalmic artery indices-PSV1,PSV2, PSV ratio will be measured. Average of 4 measurement will be taken. They will be followed up till delivery and discharge from hospital. |