| CTRI Number |
CTRI/2025/10/096740 [Registered on: 31/10/2025] Trial Registered Prospectively |
| Last Modified On: |
30/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of birth defects of baby in womb of pregnant women |
|
Scientific Title of Study
|
A One Year Observational Study Of Prevalence And Pattern Of Congenital Anomalies In A Tertiary Care Hospital In North Karnataka |
| 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 Jyoti Kushwaha |
| Designation |
OBGYN PG |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Obstetrics and Gynecology department ,First floor, JNMC KLE University Campus, Nehru Nagar, Belagavi, Karnataka,India,590010
Belgaum
KARNATAKA
590010
India |
| Phone |
8506004552 |
| Fax |
91 831-2470759 |
| Email |
jyotikushwaha2468@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Manjunath V. Hukkeri |
| Designation |
Assistant Professor of Obstetrics and Gynecology Department |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Obstetrics and Gynecology department ,First floor, JNMC KLE University Campus, Nehru Nagar, Belagavi, Karnataka,India,590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9844828201 |
| Fax |
|
| Email |
drsandi47@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyoti Kushwaha |
| Designation |
OBGYN PG |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Obstetrics and Gynecology department ,First floor, JNMC KLE University Campus, Nehru Nagar, Belagavi, Karnataka,India,590010
Belgaum
KARNATAKA
590010
India |
| Phone |
8506004552 |
| Fax |
91 831-2470759 |
| Email |
jyotikushwaha2468@gmail.com |
|
|
Source of Monetary or Material Support
|
| Obstetrics and Gynecology department ,First floor, JNMC KLE University Campus, Nehru Nagar, Belagavi, Karnataka,India,590010 |
|
|
Primary Sponsor
|
| Name |
Dr Jyoti Kushwaha |
| Address |
Obstetrics and Gynecology department ,First floor, JNMC KLE University Campus, Nehru Nagar, Belagavi, Karnataka,India,590010 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Jyoti Kushwaha |
Jawaharlal Nehru Medical College , Nehru Nagar, Belagavi, Karnataka , India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jyoti Kushwaha |
KLEs Dr. Prabhakar Kore Hospital & Medical Research Centre, Belagavi |
Obstetrics and Gynecology department ,First floor, JNMC KLE University Campus, Nehru Nagar, Belagavi, Karnataka,India,590010
Belgaum
KARNATAKA |
08506004552
831-2470759
jyotikushwaha2468@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O048||(Induced) termination of pregnancywith other and unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
All antenatal patients who had been diagnosed with anomalous fetuses on antenatal USG or who had delivered anomalous fetuses at delivery.
Patients who had undergone termination because of congenital anomalies.
|
|
| ExclusionCriteria |
| Details |
Women Who Are Not Willing To Give Consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Assess The Prevalence And Pattern Of Congenital Anomalies |
One Year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Assess The Risk Factors And Perinatal Outcome. |
One Year |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
11/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 26-08-2025 and end date provided 26-08-2035?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This one-year observational study aims to assess the prevalence, pattern, and risk factors of congenital anomalies among births and stillbirths at a tertiary care hospital in North Karnataka. Congenital anomalies, which can be structural or functional, are a major cause of perinatal mortality and long-term disability, contributing to 8–15% of perinatal deaths in India. Despite national initiatives like RBSK, region-specific data remains limited. The study will include 50 cases, using convenience sampling from antenatal and delivery records. Data will be analyzed using descriptive and inferential statistics, including logistic regression to assess associations. Key risk factors include consanguinity, poor nutrition, teratogen exposure, and late antenatal care. Findings aim to aid in better regional planning, genetic counseling, and targeted interventions for anomaly prevention. No serious adverse events or additional investigations are anticipated, and ethical consent will be obtained from all participants. This study addresses a crucial data gap in maternal-fetal health in rural India. |