| CTRI Number |
CTRI/2025/07/091144 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Tracking Heart Function from Before Birth to Infancy Using Special Heart Imaging Techniques |
|
Scientific Title of Study
|
Longitudinal assessment of myocardial function and cardiac mechanics at term pregnancy using myocardial deformation imaging; beginning from fetal life through infancy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nisha Kotian |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal |
| Address |
Department of Cardiovascular Technology, Manipal College of Health Professions, Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
9035071090 |
| Fax |
|
| Email |
kotian.nisha@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Nisha Kotian |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal |
| Address |
Department of Cardiovascular Technology, Manipal College of Health Professions, Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
9035071090 |
| Fax |
|
| Email |
kotian.nisha@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Nisha Kotian |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal |
| Address |
Department of Cardiovascular Technology, Manipal College of Health Professions, Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
9035071090 |
| Fax |
|
| Email |
kotian.nisha@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Manipal, Opposite canara mall, Madav Nagar, Hebri road , Eshwar nagar- 576104, Manipal , Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Kasturba Hospital Manipal |
| Address |
Opposite canara mall, Madav Nagar, Hebri road , Eshwar nagar- 576104, Manipal, Karnataka , India |
| 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 |
| Nisha Kotian |
Kasturba Hospital , Manipal |
Department of OBG, Fetal medicine, Ground floor , Women and children block
Udupi
KARNATAKA |
9035071090
kotian.nisha@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fetuses of term pregnant women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Fetuses of the term Pregnant women will be considered, and then followed up immediately after delivery, at 1.5 months and 3.5 months respectively |
|
| ExclusionCriteria |
| Details |
Maternal factors:
1. Multiple pregnancy.
Fetal factors:
1. Preterm fetuses
2. Major fetal anomalies having impact on fetal cardiac function
3. Fetal arrhythmias.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Intrapartum fetal compromise, intrapartum CTG abnormalities, meconium-stained liquor, any CTG abnormality requiring immediate resuscitation or delivery
Strain
|
Primary outcomes will be assessed during labour/delivery (intrapartum events) and at pre-delivery, immediately post-delivery, 1.5 months, and 3.5 months postpartum (strain analysis). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse perinatal outcome |
During & immediately after labor/ delivery |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
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)
|
31/07/2025 |
| 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="4"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study aims to to assess myocardial function and cardiac mechanics using speckle tracking echocardiography starting from prenatal life to infancy, where the fetal echocardiography will be done and the myocardial function will be assessed and then the participant is followed up and the echocardiography is performed immediately after birth, at 1.5 months and 3.5 months respectively
|