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CTRI Number  CTRI/2025/07/092023 [Registered on: 30/07/2025] Trial Registered Prospectively
Last Modified On: 29/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Symptomless Urine infection in pregnant women of Belagavi 
Scientific Title of Study   Prevalence of Asymptomatic Bacteriuria among pregnant women in Urban Belagavi: A community based study  
Trial Acronym  ASB 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bibi Aamina S  
Designation  Post Graduate  
Affiliation  Jawaharlal Nehru Medical College  
Address  Department of Community Medicine, 1st Floor, Jawaharlal Nehru Medical College, Belagavi, Karnataka 590010

Belgaum
KARNATAKA
590010
India 
Phone  7892589851  
Fax    
Email  Aaminabb21@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Asha A Bellad 
Designation  Professor  
Affiliation  Jawaharlal Nehru Medical College 
Address  Department of Community Medicine, 1st Floor, Jawaharlal Nehru Medical College,Belagavi, Karnataka 590010

Belgaum
KARNATAKA
590010
India 
Phone  9481107666  
Fax    
Email  Drashabellad@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Asha A Bellad 
Designation  Professor  
Affiliation  Jawaharlal Nehru Medical College 
Address  Department of Community Medicine, 1st Floor,Jawaharlal Nehru Medical College,Belagavi, Karnataka 590010

Belgaum
KARNATAKA
590010
India 
Phone  9481107666  
Fax    
Email  Drashabellad@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Nehru Medical College Belagavi Karnataka 590010 
 
Primary Sponsor  
Name  Dr Bibi Aamina S  
Address  Department of Community Medicine, 1st Floor,Jawaharlal Nehru Medical College Belagavi  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bibi Aamina S   Jawaharlal Nehru Medical College   Department of Community Medicine, 1st Floor, Belagavi, Karnataka 590010
Belgaum
KARNATAKA 		 7892589851

aaminabb21@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC INSTITUTIONAL ETHICS COMMITTEE JAWAHARLAL NEHRU MEDICAL COLLEGE BELAGAVI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Normal, Healthy Pregnant Women 
 
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  Antenatal women aged more than 18years of age irrespective of parity and period of gestation. 
 
ExclusionCriteria 
Details  any complains of symptomatic bacteruiria/ urine infection, any previous history of UTI in last month, known case of renal anamolies  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To estimate the prevalence of asymptomatic bacteriuria in pregnant women.  50 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To identify the factors associated with asymptomatic bacteriuria in pregnant women  50 weeks 
 
Target Sample Size   Total Sample Size="480"
Sample Size from India="480" 
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)  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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Upon reasonable request and approval by the Institutional Ethics Committee. Data sharing will require a data use agreement

  6. For how long will this data be available start date provided 23-08-2027 and end date provided 15-12-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is one of a kind study as it targets community directly. Asymptomatic Bacteriuria leading to manifestations results in IUGR, Premature Labour, Premature Rupture Of Membranes and adverse birth outcomes which can be overcome if all antenatal/pregnant women are screened for ASB during pregnancy itself and if found positive prompt treatment can be given and assured good health of the pregnant women and baby. This study will also enable us to establish risk factors associated with Asymptomatic Bacteriuria and hence help us in making it preventable. 
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