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CTRI Number  CTRI/2025/03/081522 [Registered on: 03/03/2025] Trial Registered Prospectively
Last Modified On: 21/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To compare the incidence of Asymptomatic Bacteriuria among Pregnant women screened once in Early pregnancy versus once in each trimester 
Scientific Title of Study   To compare the incidence of Asymptomatic Bacteriuria among Pregnant women screened once in Early pregnancy versus once in each trimester: a Randomised Controlled Trial 
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 Srashti Mangal 
Designation  JUNIOR RESIDENT Obstetrics and Gynaecology 
Affiliation  AIIMS Jodhpur 
Address  Department of Obstetrics and Gynaecology AIIMS Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  7014188644  
Fax    
Email  srashtimangal09@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR Navdeep Kaur Ghuman 
Designation  Professor Obstetrics and Gynaecology 
Affiliation  AIIMS JODHPUR 
Address  Department of Obstetrics & Gynaecology AIIMS Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  8107096747  
Fax    
Email  drnavdeepghuman@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR Navdeep Kaur Ghuman 
Designation  Professor Obstetrics and Gynaecology 
Affiliation  AIIMS JODHPUR 
Address  Department of Obstetrics & Gynaecology AIIMS Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  8107096747  
Fax    
Email  drnavdeepghuman@gmail.com  
 
Source of Monetary or Material Support  
AIIMS JODHPUR, 342005 , Rajasthan, India 
 
Primary Sponsor  
Name  AIIMS JODHPUR 
Address  Jodhpur , 342005, Rajasthan , India 
Type of Sponsor  Research institution and hospital 
 
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 SRASHTI MANGAL  AIIMS Jodhpur  Room no -244 Block -C Department of Obstetrics & Gynaecology 2nd floor OPD building
Jodhpur
RAJASTHAN 		 7014188644

srashtimangal09@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, All India Institute of medical science , Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: O234||Unspecified infection of urinary tract in pregnancy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Additional screening test urine culture and sensitivity   Additional screening urine urine culture and sensitivity done at 2nd and 3rd trimester . 
Comparator Agent  no additional urine culture and sensitivity test done   those pregnant women screen for asymptomatic bacteriuria once time during pregnancy by urine culture and sensitivity  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Pregnant women 
 
ExclusionCriteria 
Details  1. Pregnant women with symptoms of UTI.
2. Pregnant women with known renal diseases.
3. Pregnant women with Immunocompromised state e.g. HIV positive status, Diabetes mellitus (Type I or II), on any immunocompromised drugs.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the incidence of Asymptomatic Bacteriuria among Pregnant women screened for
asymptomatic Bacteriuria once in Early pregnancy versus once in each trimester
 		 40 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
a) To compare the incidence of UTI among two groups that is pregnant women screen once in early pregnancy versus once in each trimester.
b) To compare the incidences of Pyelonephritis among two groups that is pregnant women screen once in early pregnancy versus once in each trimester.
c) To compare the incidences of Preterm birth among two groups that is pregnant women screen once in early pregnancy versus once in each trimester.
d) To compare the incidences of Low Birth Weight among two groups that is pregnant women screen once in early pregnancy versus once in each trimester
 		 40 weeks 
 
Target Sample Size   Total Sample Size="556"
Sample Size from India="556" 
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)   17/03/2025 
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="2"
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 -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  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 - Proposals should be directed to [srashtimangal09@gmail.com].

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

Population:- Pregnant women aged 18-35 years with singleton  low risk pregnancy reporting to ANC OPD , AIIMS Jodhpur for antenatal care

Intervention :- Screening for asymptomatic bacteriuria by urine Culture& Sensitivity once early in pregnancy versus  once  in each trimester

Control:- Pregnant women aged 18-35 years with singleton  low risk pregnancy, Screened for asymptomatic bacteriuria by urine Culture& Sensitivity once early in pregnancy

Outcome:-1)Incidence of  asymptomatic bacteriuria among pregnant women

                   2)UTI

                   3)Pyelonephritis

                   4)Preterm Labor

                   5)low Birth Weight

Time duration:- 2 years 
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