NCT07001579

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
390

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2023

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 3, 2025

Completed
Last Updated

June 3, 2025

Status Verified

June 1, 2025

Enrollment Period

12 months

First QC Date

May 7, 2025

Last Update Submit

June 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    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.

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSince, it is study of Asymptomatic Urinary Tract Infection in pregnancy. This involves only female.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women visiting the Department of Obstetrics and Gynecology OPD, (Shree Birendra Hospital) located in Kathmandu for Antenatal Check-up.

You may qualify if:

  • Pregnant women attending her regular ANC check-ups at the hospital.
  • Who give consent to participate in the study.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shree Birendra Hospita

Kathmandu, Bagmati, 44600, Nepal

Location

MeSH Terms

Conditions

Urinary Tract InfectionsDisease

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

May 7, 2025

First Posted

June 3, 2025

Study Start

April 1, 2022

Primary Completion

March 14, 2023

Study Completion

August 26, 2024

Last Updated

June 3, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations