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CTRI Number  CTRI/2025/08/093701 [Registered on: 26/08/2025] Trial Registered Prospectively
Last Modified On: 24/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A one year study to find out how common silent urine infection are in pregnant women 
Scientific Title of Study   Prevalence of asymptomatic bacteriuria in antenatal women at tertiary care centre: One year cross sectional study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Cherukuri Chandra Srilekha 
Designation  MBBS, Post Graduate in MS Obstetrics and Gynaecology 
Affiliation  Jawaharlal Nehru Medical College, Belagavi 
Address  G-1 Labour room, Departement of Obstetrics and Gynaecology, KLES Dr. Prabhakar Kore Hospital and Medical Research Centre, JNMC, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9849025533  
Fax    
Email  cslcherukuri@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr.Mrityunjay Chandrashekhar Metgud 
Designation  Professor, MS Obstetrics and Gynaecology 
Affiliation  Jawaharlal Nehru Medical College, Belagavi 
Address  KLES Dr. Prabhakar Kore Hospital and Medical Research Centre, JNMC, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9164693333  
Fax    
Email  metm67@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Cherukuri Chandra Srilekha 
Designation  MBBS, Post Graduate in MS Obstetrics and Gynaecology 
Affiliation  Jawaharlal Nehru Medical College, Belagavi 
Address  G-1 Labour room, Departement of Obstetrics and Gynaecology, KLES Dr. Prabhakar Kore Hospital and Medical Research Centre, JNMC, Belagavi


KARNATAKA
590010
India 
Phone  9849025533  
Fax    
Email  cslcherukuri@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Cherukuri Chandra Srilekha 
Address  KLE Dr.Prabhakar Kore hospital,Jawaharlal Nehru Medical College, Belagavi, pincode-590010, Karnataka, India 
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 
DrCherukuri Chandra Srilekha   KLES Dr Prabhakar Kore Hospital and Medical Research Centre,JNMC Belagavi  G-1 Labour room, Departement of Obstetrics and Gynaecology, KLES Dr. Prabhakar Kore Hospital and Medical Research Centre, JNMC, Belagavi
Belgaum
KARNATAKA 
9849025533

cslcherukuri@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O988||Other maternal infectious and parasitic diseases complicating pregnancy, childbirth and the puerperium,  
 
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  All pregnant women in 2nd and 3rd trimester visiting OPD of obstetrics and gynecology at tertiary care center (KLEs DR. Prabhakar Kore Hospital, Belagavi)  
 
ExclusionCriteria 
Details  Participants with features suggestive of
UTI (such as dysuria, increased frequency and urgency)
Those with history of antibiotic therapy in the past 2 weeks
History of fever
Pregnancy-induced hypertension
Diabetes mellitus
Known congenital anomalies of urinary tract are excluded from the study.

 
 
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 2nd and 3rdtrimester antenatal women at tertiary care hospital.  Greater than 13 weeks period of gestation 
 
Secondary Outcome  
Outcome  TimePoints 
To find out the antimicrobial susceptibility profile to the commonest bacteria isolated in the urine.  Greater than 13 weeks period of gestation 
 
Target Sample Size   Total Sample Size="170"
Sample Size from India="170" 
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)   07/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  07/09/2025 
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  
Introduction and Need for the study:

Urinary tract infections (UTIs) are more frequent in women because of shorter urethra and its close proximity to anus and vagina. In pregnancy the risk increases further more due to lowered immunity, the presences of glucose in urine (renal glycosuria), and urinary stasis resulting from the relaxing effect of progesterone on smooth muscle. 

During routine antenatal visits, urine tests are commonly done to check for the presence of protein and sugar, along with microscopic examination is performed to detect red blood cell, pus cells, casts and other elements. A urine culture is also advised to detect bacteriuria. The prevalence of asymptomatic bacteriuria (ASB) ranges from 5-12% in developing countries and 2-7% in western countries. Asymptomatic bacteriuria is defined as the presence of persistent and rapidly multiplying bacteria in the urinary tract without any symptoms of urinary tract infection. A clean catch urine sample containing >105 colony forming units (CFU) per ml is considered significant for bacteriuria. Urine culture remains the gold standard for its diagnosis and is most effective as a screening tool.

The most common causative organism responsible for asymptomatic bacteriuria is Escherichia coli (80-85%), followed by staphylococci, klebsiella, pseudomonas and other. ASB is associated with various adverse outcomes for mother and fetus. Maternal complications may include symptomatic urinary tract infections in about 25% of affected women, chronic drug-resistant infections, acute pyelonephritis, preeclampsia, anemia, chorioamnionitis, endometritis, and postpartum UTIs. Fetal complications can involve prematurity, intrauterine growth restrictions (IUGR), low birth weight, and increased perinatal mortality. Early diagnosis and appropriate treatment can effectively prevent these complications. Hence, routine screening for ASB in all pregnant women is crucial. This study highlights the importance of such screening practices.

Asymptomatic bacteriuria (ASB) is defined as >105 CFU /ml of the same bacterial species in a clean catch midstream urine sample without any symptoms of urinary tract infections. Asymptomatic bacteriuria is common in pregnant women and is associated with factors such as age, living standards, parity, sexual activity, communities, different ethnicities, past history of urinary tract infection (UTI), urinary tract abnormalities, maternal history, medical history, socio-economic status, education status .and has been implicated in adverse pregnancy outcomes. 

During pregnancy, physiological changes like ureteral dilation, urinary stasis, and hormonal fluctuation increases the susceptibility to bacteriuria. In India, the report prevalence of ASB among pregnant women ranges from 7.3% to 25.3%, with variations likely due to differences in study population, location and screening technique. If left untreated, asymptomatic bacteriuria (ASB) during pregnancy can lead to serious maternal and fetal complications. Therefore, routine screening and timely management of ASB in pregnant women are crucial to improve pregnancy outcomes.

Escherichia coli remains the most commonly isolated uro-pathogen in cases of asymptomatic bacteriuria (ASB) among pregnant women in India, followed by Klebsiella pneumoniae and Staphylococcus aureus. Antibiotic susceptibility studies indicate that these organisms often show resistance to commonly prescribed antibiotics, emphasizing the importance of conducting urine culture and sensitivity testing to guide effective treatment. Despite the proven advantage of early detection routine urine culture and sensitivity screening is still not widely practiced in many healthcare facilities in India. This study aims to assess the prevalence of asymptomatic bacteriuria (ASB) in pregnant women attending a tertiary care hospital, identify the causative organisms, and evaluate their antibiotic resistance profile.
 
Data collection procedure:

·       Over a period of 12months, the women in 2nd and 3rd trimester visiting to obstetrics and gynecology OPD at tertiary care center (KLEs DR. Prabhakar Kore Hospital, Belagavi) are going to be included in the study.

·       After informed consent the respective antenatal women midstream urine specimen will be send to the microbiology lab for urine culture and sensitivity.

·       After 72 hours the report is collected and noted.

·       In addition to the above details, the demographics (maternal age, residence, occupation, socio- economic status, educational status) of pregnant women will be obtained and their antenatal record is noted.

·       Detailed antenatal history and presenting complaints will also be noted.

·       The general examination and obstetrics examination of the pregnant women will be noted.

·       Routine obstetrics investigations will be noted. (Complete blood count, Urine routine and examination, Serum Thyroid Stimulating Hormone, DIPSI, HIV status, HBsAg status, VDRL status).

·       Intra-natal events of each pregnant women and feto-maternal outcome involved in the study will be noted


 
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