| 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
|
|
|
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
|
|
|
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. |