| CTRI Number |
CTRI/2026/01/100083 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
31/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding the Causes of Stillbirths and Newborn Deaths Using SmartVA |
|
Scientific Title of Study
|
Determining the Distribution and Causes of Stillbirth and Neonatal Deaths Using Smart VA |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nikita G Naik |
| Designation |
Postgraduate Student |
| Affiliation |
School of Public Health KAHER University , Belagavi |
| Address |
School of Public Health, KAHER, Nehru Nagar Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
6363131947 |
| Fax |
|
| Email |
naiknikita2109@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prof Mubashir Angolkar |
| Designation |
Head School of Public Health |
| Affiliation |
School of Public Health KAHER University , Belagavi |
| Address |
School of Public Health, KAHER, Nehru Nagar Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
9886983624 |
| Fax |
|
| Email |
drmubi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nikita G Naik |
| Designation |
Postgraduate Student |
| Affiliation |
School of Public Health KAHER University , Belagavi |
| Address |
School of Public Health, KAHER, Nehru Nagar Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
6363131947 |
| Fax |
|
| Email |
naiknikita2109@gmail.com |
|
|
Source of Monetary or Material Support
|
| School Of Public Health, KAHER, Nehru Nagar, Belagavi |
|
|
Primary Sponsor
|
| Name |
Nikita G Naik |
| Address |
School of Public Health, KAHER, Nehru Nagar Belagavi, Karnataka 590001 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Nikita G Naik |
Bhendigiri PHC |
Bhendigiri, Belagavi
Belgaum
KARNATAKA |
6363131947
naiknikita2109@gmail.com |
| Nikita G Naik |
Hindalga PHC |
Vinayak Nagar, Hindalga Belagavi
Belgaum
KARNATAKA |
6363131947
naiknikita2109@gmail.com |
| Nikita G Naik |
Yallur PHC |
Yallur, Belagavi.
Belgaum
KARNATAKA |
6363131947
naiknikita2109@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee |
Approved |
| JNMC Institutional Ethics Committee |
Approved |
| JNMC Institutional Ethics Committee |
Approved |
| JNMC Institutional Ethics Committee |
Approved |
| JNMC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: P039||Newborn affected by complication of labor and delivery, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Neonatal Deaths and Stillbirths Between January 2025-December2025 |
|
| ExclusionCriteria |
| Details |
Cases will not be included if the information from the VA interviews is not complete.
Respondents who were closely related with the deceased and who do not give consent to participate. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cause-assignment |
4-6 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of deaths by place of birth or place of death. |
3-4 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="87"
Sample Size from India="70"
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)
|
15/01/2026 |
| 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="0"
Months="10"
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 - NO
|
|
Brief Summary
|
This study aims to identify the distribution and causes of stillbirths and neonatal deaths in selected PHCs of Belagavi using the SmartVA verbal autopsy tool. All stillbirths and neonatal deaths recorded between January and December 2025 will be assessed through standardized WHO-based verbal autopsy interviews using the PHMRC Shortened Questionnaire. The SmartVA-Analyze (Tariff 2.0) software will assign probable causes of death at both individual and population levels. The study will help generate reliable, community-level mortality data where medical certification is limited, support understanding of preventable factors, and guide public health interventions to reduce stillbirth and neonatal mortality. |