| CTRI Number |
CTRI/2023/07/055254 [Registered on: 16/07/2023] Trial Registered Prospectively |
| Last Modified On: |
14/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
To look for the difference in maternal cerebral circulation between growth restricted fetuses and appropriately grown fetuses. |
|
Scientific Title of Study
|
TO STUDY THE MATERNAL OPHTHALMIC ARTERY RATIO OF PEAK SYSTOLIC VELOCITIES IN PREGNANT WOMEN WITH GROWTH RESTRICTED FETUSES AND THEIR COMPARISON WITH APPROPRIATE FOR GESTATIONAL AGE |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr JAYA CHAWLA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Dr Ram manohar lohia hospital |
| Address |
GYNAE OFFICE Dr RML HOSPITAL
New Delhi
DELHI
110001
India |
| Phone |
9871115949 |
| Fax |
|
| Email |
jayachawla51@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr JAYA CHAWLA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Dr Ram manohar lohia hospital |
| Address |
GYNAE OFFICE,obstetrics and gynaecology dept, Dr RML HOSPITAL
DELHI
110001
India |
| Phone |
9871115949 |
| Fax |
|
| Email |
jayachawla51@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PALVI SHARMA |
| Designation |
PG RESIDENT OBSTETRICS AND GYNAECOLOGY |
| Affiliation |
Dr Ram manohar lohia hospital |
| Address |
GYNAE OFFICE,obstetrics and gynaecology , Dr RML HOSPITAL
DELHI
110001
India |
| Phone |
9871115949 |
| Fax |
|
| Email |
palvisharma64964@gmail.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS AND DR RML HOSPITAL |
|
|
Primary Sponsor
|
| Name |
ABVIMS AND DR RML HOSPITAL |
| Address |
Baba Kharak Singh Rd near Gurudwara Bangla Sahib Ram Manohar Lohia Hospital Type III Connaught Place Central Delhi Delhi India 110001, gynae office.
|
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| 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 PALVI SHARMA |
ABVIMS AND DR RML HOSPITAL |
Gynae office MNH department of obs & gynae ABVIMS & RML Hospital Baba Kharak Singh Rd near Gurudwara Bangla Sahib Ram Manohar Lohia Hospital Type III Connaught Place Central Delhi Delhi India 110001, gynae office.
New Delhi
DELHI |
7889778968
palvisharma64964@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| THE INSTITUTIONAL ETHICS COMMITTEE ABVIMS DR RML HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium, (2) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
singleton live pregnancy |
|
| ExclusionCriteria |
| Details |
1 Suspected congenital anomalies
2 Overt diabetes
3 Glaucoma
4 Severe heart disease
5 Pre-eclampsia
6 Chronic hypertension
7 Vasculopathies
 
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ratio of peak systolic velocities in maternal ophthalmic artery Doppler |
35weeks and 38weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association of ophthalmic artery Doppler parameter changes with feto-maternal outcome |
other opthalmic artery dopplers will also be compared |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
25/07/2023 |
| 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 Yet Recruiting |
| 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
|
This study compares the difference between changes in maternal cerebral circulation in pregnant mothers with growth restricted fetuses and appropriately grown fetuses this. we will recruit patients at 35-38 weeks period of gestation and get clearance from ophthalmology to rule out glaucoma.then we will do obs doppler to differentiate between growth restricted fetuses and appropriately grown fetuses.then we will do maternal ophthalmic artery doppler in both and compare their ophthalmic artery doppler ratio of peak systolic velocities.ophthalmic artery is in direct communication with cerebral circulation.so in this way we will compare the cerebraL circulation changes between them |