| CTRI Number |
CTRI/2026/02/104856 [Registered on: 26/02/2026] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of fetal myocardial performance index in evaluation of fetal growth restriction |
|
Scientific Title of Study
|
Clinical application of fetal myocardial performance index in evaluation of fetal growth restriction |
| 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 Sanchita Narayanan |
| Designation |
Junior resident |
| Affiliation |
Manipal Academy of higher education |
| Address |
Kasturba Hospital Manipal
Tiger circle road. Madhav Nagar
Udupi
KARNATAKA
576104
India |
| Phone |
8420039933 |
| Fax |
|
| Email |
sanchitan99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shripad Hebbar |
| Designation |
Head of unit and Professor in department of Obstetrics and Gynaecology |
| Affiliation |
|
| Address |
Kasturba Hospital Manipal
Tiger circle road. Madhav Nagar
Udupi
KARNATAKA
576104
India |
| Phone |
9611786463 |
| Fax |
|
| Email |
Shripad.hebbar@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanchita Narayanan |
| Designation |
Junior resident |
| Affiliation |
Manipal Academy of higher education |
| Address |
Kasturba Hospital Manipal
Tiger circle road. Madhav Nagar
Udupi
KARNATAKA
576104
India |
| Phone |
8420039933 |
| Fax |
|
| Email |
sanchitan99@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Sanchita Narayanan |
| Address |
Kasturba Hospital Manipal, Tiger circle Road, Madhav Nagar |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Sanchita Narayanan |
Kasturba Hospita, Manipal |
Department of obstertrics and gynaecology, Ground floor Women and Child Block ,Tiger circle Road, Madhav nagar
Udupi
KARNATAKA |
8420039933
sanchitan99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Hospital Institutional ethics committee 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, (2) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Diagnosed cases of fetal growth restriction on the basis of antenatal scans |
|
| ExclusionCriteria |
| Details |
Fetus with structural or chromosomal anomaly |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of fetal cardiac dysfunction using myocardial performance index in fetuses with IUGR |
Single measurement when IUGR is first diagnosed |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation between myocardial performance index values & perinatal outcomes |
at recruitment & subsequent follow ups |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
15/03/2026 |
| 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="2"
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 research aids in assessing fetal myocardial indices in response to chronic stress, making it a potentially earlier and more sensitive indicator of fetal compromise. The findings could help bridge the current diagnostic gap, improve fetal surveillance strategies, and potentially reduce adverse outcomes associated with undetected or late-detected fetal cardiac dysfunction. Traditional methods for FGR evaluation, such as fetal biometry and Doppler velocimetry of the umbilical and uterine arteries, provide valuable information regarding placental insufficiency but may not sufficiently reflect fetal cardiac compromise, especially in the early stages. |