| CTRI Number |
CTRI/2025/07/091923 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
16/04/2026 |
| 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 stress during pregnancy in belagavi |
|
Scientific Title of Study
|
Prevalence of Stress in Pregnancy in Rural and Urban Field Practice Area of Belagavi |
| 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 Harshitha K |
| Designation |
Junior resident |
| Affiliation |
Jawaharlal Nehru Medical college |
| Address |
Gangambika ladies hostel, room no. 77,Jawaharlal Nehru Medical college, nehrunagar, Belagavi, (residential address)
Plot no 115,RK Avenue, near Dinnur bus stop, opp fair mart, Hosur, Tamil Nadu, 635109 (permanent address)
Belgaum
KARNATAKA
590010
India |
| Phone |
9486981580 |
| Fax |
|
| Email |
harshithareddy0305@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Umesh S. Charantimath |
| Designation |
Associate proffesor |
| Affiliation |
Jawaharlal Nehru Medical college |
| Address |
Jawaharlal Nehru Medical college, nehrunagar, Belagavi,
Jawaharlal Nehru Medical college, nehrunagar, Belagavi,
Belgaum
KARNATAKA
590010
India |
| Phone |
9663712777 |
| Fax |
|
| Email |
Drumesh.charantimath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harshitha K |
| Designation |
Junior resident |
| Affiliation |
Jawaharlal Nehru Medical college |
| Address |
Jawaharlal Nehru Medical college, nehrunagar, Belagavi,
Room no. 77, Gangambika ladies hostel, JNMC campus
Belgaum
KARNATAKA
590010
India |
| Phone |
9486981580 |
| Fax |
|
| Email |
harshithareddy0305@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical college |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical college |
| Address |
Jawaharlal Nehru Medical college, nehrunagar, Belagavi, 590010 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Harshitha K |
Jawaharlal Nehru Medical college |
JNMC KLE University Campus, Nehru Nagar, Belagavi, Karnataka 590010
Belgaum
KARNATAKA |
9486981580
harshithareddy0305@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jawaharlal Nehru Medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O20-O29||Other maternal disorders predominantly related to pregnancy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women in second trimester |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gives the burden of stress during pregnancy |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="770"
Sample Size from India="770"
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)
|
15/08/2025 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study aims to assess how common stress is among pregnant women in both rural and urban areas of Belagavi. Stress during pregnancy can negatively impact both the mother and baby, leading to complications like low birth weight, preterm birth, and more. Using a cross-sectional design, the study will survey 770 pregnant women in their second trimester, using the Perceived Stress Scale-10 and demographic questionnaires. Understanding the prevalence and causes of antenatal stress in different settings will help in planning better support systems and healthcare interventions for pregnant women in the community. Ethical clearance and informed consent are ensured.
|