| CTRI Number |
CTRI/2025/08/092463 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Burden of Smokeless Tobacco use in pregnant women |
|
Scientific Title of Study
|
Prevalence of Smokeless Tobacco use among pregnant women in Belagavi,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 |
Vinay V Horapeti |
| Designation |
Post Graduate 1st year |
| Affiliation |
J N MEDICAL COLLEGE BELAGAVI |
| Address |
Departmentof Community Medicine
1st Floor Demo Room-10 J.N.Medical College Belagavi, Karnataka.
Belgaum
KARNATAKA
590010
India |
| Phone |
8296592598 |
| Fax |
|
| Email |
vinayvhorapeti10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Yogesh Kumar S |
| Designation |
Professor |
| Affiliation |
J N MEDICAL COLLEGE BELAGAVI |
| Address |
Department of Community Medicine 1st Floor
J.N. Medical College Belagavi,Karnataka.
Belgaum
KARNATAKA
590010
India |
| Phone |
9448273305 |
| Fax |
|
| Email |
yogeshkumar23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vinay V Horapeti |
| Designation |
Post Graduate 1st year |
| Affiliation |
J N MEDICAL COLLEGE BELAGAVI |
| Address |
Department of Community Medicine 1st Floor J.N Medical College Belagavi,Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
8296592598 |
| Fax |
|
| Email |
vinayvhorapeti10@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Vinay V Horapeti |
| Address |
Department of Community Medicine 1st Floor J.N medical college Belagavi,Karnataka
590010 |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
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 |
| Vinay V Horapeti |
PHC kinaye, Vantamuri UPHC Rukmini nagar l, Ashok nagar |
Belagavi,Karnataka
Belgaum
KARNATAKA |
8296592598
vinayvhorapeti10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMCINSTITUTIONALETHICSCOMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
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 |
1) Pregnant Women aged 18- 49 years
2) Include Women residing in the specified
Geographic location relevant to study |
|
| ExclusionCriteria |
| Details |
1) Pregnant women using smoking Form of Tobacco
2)Pregnant Women with Medical and Psychiatric condition.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Determine the prevalence of Smokeless Tobacco use in Pregnant women. |
10-20 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the various socio-demographic factors associated with smokeless tobacco use among pregnant women. |
10-20 Weeks |
|
|
Target Sample Size
|
Total Sample Size="810"
Sample Size from India="810"
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)
|
15/10/2025 |
| 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="1"
Months="0"
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
|
Smokeless tobacco use is a significant public health concern, particularly among pregnant women. In India, smokeless tobacco is widespread and its use is increasing, posing health risks to both the mother and the fetus, such as stillbirth, low birth weight, and sudden infant death syndrome. According to the National Family Health Survey-4 (2015-2016), approximately 5-8 percent of pregnant women in India use tobacco in some form. The harmful effects on fetal health are similar to those of cigarette smoking. The guide’s remarks state that this study will provide valuable information for planning preventive measures for the safety of mothers and children. |