| 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
|
|
|
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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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
|