Urinary Tract Infection (Diagnosis)NCT07001579
Cross-sectional Study of the Prevalence and Risk Factors of Asymptomatic Bacteriuria in Pregnancy
An observational study of Urinary Tract Infection (Diagnosis) and Pregnancy, run by Nepalese Army Institute of Health Sciences at 1 site in Nepal.
Trial summary
Asymptomatic bacteriuria (ASB) is the presence of bacteria in the urine without symptoms of urinary tract infection. It is common during pregnancy and, if left untreated, may lead to complications such as pyelonephritis, preterm labor, and low birth weight. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Tract Infection (Diagnosis), Pregnancy
- How many people
- 390 participants
- Where
- 1 siteNepal
- Study dates
- 1 Apr 2022to 26 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women visiting the Department of Obstetrics and Gynecology OPD, (Shree Birendra Hospital) located in Kathmandu for Antenatal Check-up.
Who may be able to join
- Pregnant women attending her regular ANC check-ups at the hospital.
- Who give consent to participate in the study.
Who cannot join
- Individuals not willing to participate
- Pregnant women showing signs and symptoms of UTI.
- Pregnant women on antibiotics or had been on antibiotics at least two weeks prior to presentation.
- Pregnant women with known underlying renal pathology.
- Pregnant women who are using immune-suppressants.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence and Associated Risk Factors of Asymptomatic Bacteriuria in Pregnancy at a Tertiary Care Hospital: a Cross-sectional Duty
Asymptomatic bacteriuria (ASB) is the presence of bacteria in the urine without symptoms of urinary tract infection. It is common during pregnancy and, if left untreated, may lead to complications such as pyelonephritis, preterm labor, and low birth weight. This cross-sectional study aims to determine the prevalence and identify associated risk factors of ASB among pregnant women attending antenatal care at a tertiary care hospital. Pregnant women meeting the inclusion criteria will be enrolled and evaluated through urine analysis and relevant history-taking. The findings may help guide future screening and treatment policies in antenatal care settings
- Conditions
- Urinary Tract Infection (Diagnosis), Pregnancy
- Medical subject headings
- Urinary Tract Infections, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Asymptomatic Bacteriuria in Pregnant Women
The proportion of pregnant women attending antenatal care who test positive for asymptomatic bacteriuria based on urine culture
Measured: Data was collected for 6 months after approval from IRC from April 2022 to September 2022 during each participant's first antenatal care (ANC) visit irrespective of the gestational age, using simple convenient sampling method.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start1 Apr 2022
- Primary completion14 Mar 2023
- Study completion26 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract Infection (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nepalese Army Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabin Poudel, Nepalese Army Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07001579
- Sponsor's protocol ID
- SBH-AUTI-2022-01
- Status last verified
- Jun 2025
- First submitted
- 7 May 2025
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Associated Risk Factors of Asymptomatic Bacteriuria in Pregnancy at a Tertiary Care Hospital: a Cross-sectional Duty
- ClinicalTrials.gov ID
- NCT07001579
- Acronym / sponsor ID
- SBH-AUTI-2022-01
- Conditions
- Urinary Tract Infection (Diagnosis), Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Nepalese Army Institute of Health SciencesUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 14 Mar 2023 (actual)
- Study completion
- 26 Aug 2024 (actual)
- First posted
- 3 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Asymptomatic bacteriuria (ASB) is the presence of bacteria in the urine without symptoms of urinary tract infection. It is common during pregnancy and, if left untreated, may lead to complications such as pyelonephritis, preterm labor, and low birth weight. This cross-sectional study aims to determine the prevalence and identify associated risk factors of ASB among pregnant women attending antenatal care at a tertiary care hospital. Pregnant women meeting the inclusion criteria will be enrolled and evaluated through urine analysis and relevant history-taking. The findings may help guide future screening and treatment policies in antenatal care settings
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women visiting the Department of Obstetrics and Gynecology OPD, (Shree Birendra Hospital) located in Kathmandu for Antenatal Check-up.
Key inclusion criteria (2 listed)
- Pregnant women attending her regular ANC check-ups at the hospital.
- Who give consent to participate in the study.
Key exclusion criteria (5 listed)
- Individuals not willing to participate
- Pregnant women showing signs and symptoms of UTI.
- Pregnant women on antibiotics or had been on antibiotics at least two weeks prior to presentation.
- Pregnant women with known underlying renal pathology.
- Pregnant women who are using immune-suppressants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of Asymptomatic Bacteriuria in Pregnant Women
Time frame: Data was collected for 6 months after approval from IRC from April 2022 to September 2022 during each participant's first antenatal care (ANC) visit irrespective of the gestational age, using simple convenient sampling method.
The proportion of pregnant women attending antenatal care who test positive for asymptomatic bacteriuria based on urine culture
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infection (Diagnosis) and Pregnancy, run by Nepalese Army Institute of Health Sciences at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Asymptomatic Bacteriuria in Pregnant Women (time frame: Data was collected for 6 months after approval from IRC from April 2022 to September 2022 during each participant's first antenatal care (ANC) visit irrespective of the gestational age, using simple convenient sampling method.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.