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CTRI Number  CTRI/2024/04/066220 [Registered on: 24/04/2024] Trial Registered Prospectively
Last Modified On: 22/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Checking how the babys heart valve structures are doing during a special scan before birth 
Scientific Title of Study   Evaluation of fetal cardiac valves during fetal echo 
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 Saachi Todi 
Designation  Junior Resident 
Affiliation  Kasturba Medical college, Manipal Academy of Higher education, Manipal 
Address  Department of Obstetrics and Gynaecology, Kasturba Medical college, Manipal Academy of Higher education, Manipal- 576104, Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  9223389481  
Fax    
Email  saachi@todi.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Roopa P S 
Designation  Additional Professor 
Affiliation  Kasturba Medical college, Manipal Academy of Higher education, Manipal 
Address  Department of Obstetrics and Gynaecology, Kasturba Medical college, Manipal Academy of Higher education, Manipal- 576104, Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  9008415729  
Fax    
Email  roopa.ps@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Roopa P S 
Designation  Additional Professor 
Affiliation  Kasturba Medical college, Manipal Academy of Higher education, Manipal 
Address  Department of Obstetrics and Gynaecology, Kasturba Medical college, Manipal Academy of Higher education, Manipal- 576104, Karnataka, India


KARNATAKA
576104
India 
Phone  9008415729  
Fax    
Email  roopa.ps@manipal.edu  
 
Source of Monetary or Material Support  
Department of Obstetrics and Gynaecology, Kasturba Medical College, Manipal 
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [NA] 
 
Details of Secondary Sponsor  
Name  Address 
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 Saachi Todi  Kasturba Medical college, Manipal  Department of Obstetrics and Gynaecology, Woman and child block, ground floor, Kasturba Medical college, Manipal- 576104, Karnataka, India
Udupi
KARNATAKA 
9223389481

saachi@todi.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee 2 Student Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O369||Maternal care for fetal problem, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  Singleton pregnancy
Antenatal mothers beyond 18 weeks of gestation 
 
ExclusionCriteria 
Details  Multiple gestation
Antenatal mothers before 18 weeks of gestation 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Early diagnosis of congenital heart diseases  From 18 weeks onwards 
 
Secondary Outcome  
Outcome  TimePoints 
Intrapartum outcome of pregnancy in terms of mode of delivery NVD or LSCS  From 18 weeks onwards 
 
Target Sample Size   Total Sample Size="585"
Sample Size from India="585" 
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)   02/05/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  
Our data could be used for assessing the feasibility of screening fetal cardiac valves during the routine echo. This will aid in early diagnosis of congenital heart diseases leading to better pregnancy outcomes. The assessment of fetal cardiac valves during routine fetal echocardiography is of paramount importance due to the limitations and subjectivity associated with current evaluation methods. Traditional methods rely on two-dimensional echocardiography (2DE), which may not provide a comprehensive and accurate representation of fetal cardiac structures. The feasibility to evaluate fetal cardiac valves becomes crucial as 2DE can be limited in depicting subtle malformations, and there is a need for a more objective and advanced approach. Screening of fetal cardiac valves requires skill, experience, equipment, time and appropriate planes of view. We will study these factors and assess the feasibility of screening of fetal cardiac valves to include it during our routine fetal echo. Given the potential impact on prenatal diagnosis and patient care, incorporating advanced imaging techniques for fetal cardiac assessment aligns with the need for more accurate and objective methodologies. Establishing reference ranges for fetal cardiac valve diameters could significantly enhance the precision of routine evaluations, providing clinicians with a standardized and
reliable tool. This research is justified by the necessity to overcome the limitations of current practices, ensuring better-informed decisions, and ultimately improving outcomes for both mothers and fetuses.
 
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