| CTRI Number |
CTRI/2026/02/103370 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
07/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Early Detection of Baby’s congenital Heart Conditions Through Pregnancy Scans and Community Awareness in Rural India |
|
Scientific Title of Study
|
Assessment of spectrum of congenital cardiovascular anomalies detected in ante-natal fetal echocardiography scan and to increase awareness in rural population of central India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ishita Rai |
| Designation |
Post graduate student |
| Affiliation |
Jawaharlal nehru medical college,Sawangi (Meghe)Wardha, Maharastra |
| Address |
Department of Radiodiagnosis, Jawaharlal Nehru Medical College and Acharya Vinoba Bhave
Rural Hospital, Data Meghe Institute of Higher Education & Research (DU), Sawangi (Meghe), Wardha.
Jawaharlal nehru medical college,Sawangi(Meghe)Wardha, Maharastra
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9755314738 |
| Fax |
|
| Email |
raiishita23.10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PHParihar |
| Designation |
HOD and Professor |
| Affiliation |
Jawaharlal nehru medical college,Sawangi (Meghe)Wardha, Maharastra |
| Address |
Department of radiodiagnosis, Jawaharlal nehru medical college,and Acharya Vinoba Bhave
Rural Hospital, Data Meghe Institute of Higher Education & Research (DU), Sawangi (Meghe), Wardha.Maharastra
442101
India
Department of radiodiagnosis, Jawaharlal nehru medical college,Sawangi(Meghe)Wardha, Maharastra
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9422104957 |
| Fax |
|
| Email |
drphparihar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PHParihar |
| Designation |
HOD and Professor |
| Affiliation |
Jawaharlal nehru medical college,Sawangi (Meghe)Wardha, Maharastra |
| Address |
Department of radiodiagnosis, Jawaharlal nehru medical college,and Acharya Vinoba Bhave
Rural Hospital, Data Meghe Institute of Higher Education & Research (DU), Sawangi (Meghe), Wardha.Maharastra
442101
India
Jawaharlal nehru medical college,Sawangi(Meghe)Wardha, Maharastra
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9422104957 |
| Fax |
|
| Email |
drphparihar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal nehru medical college,sawangi,meghe wardha
442001,maharashtra |
|
|
Primary Sponsor
|
| Name |
Jawaharlal nehru medical collegeData Meghe Institute of Higher Education Research DU wardha |
| Address |
Jawaharlal nehru medical college,and Acharya Vinoba Bhave
Rural Hospital, Data Meghe Institute of Higher Education & Research, Sawangi Meghe, Wardha Maharastra,442001 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DrIshita Rai |
Acharya Vinoba Bhave Rural Hospital, Data Meghe Institute of Higher Education & Research |
Department of Radiodiagnosis, Jawaharlal Nehru Medical College, and Acharya Vinoba Bhave
Rural Hospital, Data Meghe Institute of Higher Education & Research, Sawangi (Meghe)
Wardha
MAHARASHTRA |
9755314738
raiishita23.10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q209||Congenital malformation of cardiacchambers and connections, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women between 18 to 49 years undergoing routine or referred antenatal ultrasound scans between 18-24 weeks.
Singleton pregnancies evaluated by foetal echocardiography.
Cases residing in rural areas of Central India.
Patients who consent to participate in the study and follow-up postnatally.
|
|
| ExclusionCriteria |
| Details |
Poor image quality due to maternal obesity, severe oligohydramnios, or fetal positioning.
Patient not willing to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in awareness regarding congenital cardiovascular anomalies detected in antenatal fetal echocardiography scan and to increase awareness and to increase awareness in rural population. |
Assessment will be done at 24 weeks and 28 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
01/03/2026 |
| 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="6"
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
|
Congenital cardiovascular anomalies (CCAs) are a major cause of neonatal illness and death. Foetal echocardiography offers a reliable method for early detection during pregnancy, enabling timely intervention and counselling. However, in rural areas of Central India, limited awareness, late antenatal registration, and poor access to specialized scans contribute to missed or delayed diagnosis. There is also a lack of regional data on the types of CCAs diagnosed prenatally in these populations. This study aims to assess the spectrum of CCAs detected through foetal echocardiography in rural Central India, while also highlighting the need to improve awareness and accessibility of antenatal cardiac screening in underserved communities.This study aims to study spectrum of congenital cardiovascular anomalies detected in ante-natal fetal echocardiography scan with increase awareness in rural population in central India.This will be a cross sectional prospective study conducted in AVBRH, JNMC DMIHER, Wardha. |