Pre-EclampsiaNCT07866196
Prevalence of Asymptomatic Bacteriuria Among Pregnant Women With Pre-eclampsia in Women Health Hospital Assiut University
An observational study of Pre-Eclampsia and Asymptomatic Bacteriuria, run by Assiut University.
Trial summary
Pre-eclampsia is a hypertensive disorder of pregnancy that can lead to significant health complications for both the mother and the fetus. Asymptomatic bacteriuria (ASB) occurs when significant amounts of bacteria are present in the urinary tract without causing symptoms such as burning, pain, or fever. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pre-Eclampsia, Asymptomatic Bacteriuria
- How many people
- 129 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 45 years
- Women only
- Adult
Study population: Pregnant women diagnosed with pre-eclampsia attending the inpatient wards and outpatient clinics of the Department of Obstetrics and Gynecology at Women's Health Hospital, Assiut University Hospitals, who are at 20 or more weeks of gestation and present without clinical symptoms of a urinary tract infection.
Who may be able to join
- Pregnant women aged 18 to 45 years
- Gestational age ≥ 20 weeks
- Singleton or multiple pregnancy
- Clinically diagnosed with pre-eclampsia
- Absence of clinical symptoms suggestive of a urinary tract infection (dysuria, urgency, frequency, suprapubic pain, or fever)
- Provision of signed written informed consent
Who cannot join
- Presence of clinical symptoms of a urinary tract infection
- History of antimicrobial/antibiotic therapy within the preceding 2 weeks prior to recruitment
- Documented pre-existing chronic kidney disease
- Known congenital or acquired structural urinary tract abnormalities
- Diabetes mellitus with concurrent urinary symptoms
- Refusal to provide informed consent or participate in the study
About this study
Official title: Prevalence of Asymptomatic Bacteriuria Among Pregnant Women With Pre-eclampsia in Women Health Hospital Assiut University: A Cross-Sectional Study
Pre-eclampsia is a hypertensive disorder of pregnancy that can lead to significant health complications for both the mother and the fetus. Asymptomatic bacteriuria (ASB) occurs when significant amounts of bacteria are present in the urinary tract without causing symptoms such as burning, pain, or fever. Research suggests that persistent, asymptomatic bacterial growth can stimulate inflammatory responses and endothelial dysfunction, which may contribute to or worsen pre-eclampsia. However, local data regarding how frequently this condition occurs among pre-eclamptic women in Assiut remains limited.
The primary purpose of this cross-sectional study is to determine the prevalence of asymptomatic bacteriuria among pregnant women diagnosed with pre-eclampsia admitted to or attending the Department of Obstetrics and Gynecology at Women's Health Hospital, Assiut University. The study also aims to identify the specific bacterial species responsible for these infections, assess their antibiotic susceptibility profiles, and evaluate potential sociodemographic and clinical risk factors.
Enrolled participants will be asked to complete a structured interview questionnaire regarding their medical history, obstetric history, and sociodemographic details. Each participant will provide a single clean-catch midstream urine sample for quantitative urine culture and microbiological analysis. Positive culture results will be communicated to the treating clinical team to guide targeted antibiotic management.
- Conditions
- Pre-Eclampsia, Asymptomatic Bacteriuria
- Keywords
- Pregnancy, Urine Culture, Urinary Tract Infection, Antimicrobial Susceptibility, Hypertensive Disorders of Pregnancy, Bacterial Colonization
- Medical subject headings
- Pre-Eclampsia, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Women With Pre-eclampsia | Pregnant women aged 18 to 45 years at 20 or more weeks of gestation diagnosed with pre-eclampsia and presenting without clinical symptoms of a urinary tract infection. All participants complete a structured questionnaire covering sociodemographic and obstetric data and provide a clean-catch midstream urine specimen for quantitative culture, bacterial identification, and antimicrobial susceptibility testing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Asymptomatic Bacteriuria
Asymptomatic bacteriuria is defined as significant bacterial growth (≥10^5 CFU/mL of a single bacterial pathogen) isolated from a clean-catch midstream urine culture in the absence of urinary tract infection symptoms. It will be calculated as the number of pre-eclamptic pregnant women with confirmed bacteriuria divided by the total number of enrolled participants, expressed as a percentage.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 129 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07866196
- Sponsor's protocol ID
- ASB in Pre-eclamptic Pregnancy
- Status last verified
- Oct 2026
- First submitted
- 4 Oct 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Asymptomatic Bacteriuria Among Pregnant Women With Pre-eclampsia in Women Health Hospital Assiut University: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07866196
- Acronym / sponsor ID
- ASB in Pre-eclamptic Pregnancy
- Conditions
- Pre-Eclampsia, Asymptomatic Bacteriuria
- Keywords
- Pregnancy, Urine Culture, Urinary Tract Infection, Antimicrobial Susceptibility, Hypertensive Disorders of Pregnancy, Bacterial Colonization
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 129 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 Oct 2026 (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.
Pre-eclampsia is a hypertensive disorder of pregnancy that can lead to significant health complications for both the mother and the fetus. Asymptomatic bacteriuria (ASB) occurs when significant amounts of bacteria are present in the urinary tract without causing symptoms such as burning, pain, or fever. Research suggests that persistent, asymptomatic bacterial growth can stimulate inflammatory responses and endothelial dysfunction, which may contribute to or worsen pre-eclampsia. However, local data regarding how frequently this condition occurs among pre-eclamptic women in Assiut remains limited.
The primary purpose of this cross-sectional study is to determine the prevalence of asymptomatic bacteriuria among pregnant women diagnosed with pre-eclampsia admitted to or attending the Department of Obstetrics and Gynecology at Women's Health Hospital, Assiut University. The study also aims to identify the specific bacterial species responsible for these infections, assess their antibiotic susceptibility profiles, and evaluate potential sociodemographic and clinical risk factors.
Enrolled participants will be asked to complete a structured interview questionnaire regarding their medical history, obstetric history, and sociodemographic details. Each participant will provide a single clean-catch midstream urine sample for quantitative urine culture and microbiological analysis. Positive culture results will be communicated to the treating clinical team to guide targeted antibiotic management.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant Women With Pre-eclampsia | – | –Pregnant women aged 18 to 45 years at 20 or more weeks of gestation diagnosed with pre-eclampsia and presenting without clinical symptoms of a urinary tract infection. All participants complete a structured questionnaire covering sociodemographic and obstetric data and provide a clean-catch midstream urine specimen for quantitative culture, bacterial identification, and antimicrobial susceptibility testing. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Pregnant women diagnosed with pre-eclampsia attending the inpatient wards and outpatient clinics of the Department of Obstetrics and Gynecology at Women's Health Hospital, Assiut University Hospitals, who are at 20 or more weeks of gestation and present without clinical symptoms of a urinary tract infection.
Key inclusion criteria (6 listed)
- Pregnant women aged 18 to 45 years
- Gestational age ≥ 20 weeks
- Singleton or multiple pregnancy
- Clinically diagnosed with pre-eclampsia
- Absence of clinical symptoms suggestive of a urinary tract infection (dysuria, urgency, frequency, suprapubic pain, or fever)
Key exclusion criteria (6 listed)
- Presence of clinical symptoms of a urinary tract infection
- History of antimicrobial/antibiotic therapy within the preceding 2 weeks prior to recruitment
- Documented pre-existing chronic kidney disease
- Known congenital or acquired structural urinary tract abnormalities
- Diabetes mellitus with concurrent urinary symptoms
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
Percentage of Participants With Asymptomatic Bacteriuria
Time frame: Baseline
Asymptomatic bacteriuria is defined as significant bacterial growth (≥10^5 CFU/mL of a single bacterial pathogen) isolated from a clean-catch midstream urine culture in the absence of urinary tract infection symptoms. It will be calculated as the number of pre-eclamptic pregnant women with confirmed bacteriuria divided by the total number of enrolled participants, expressed as a percentage.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-Eclampsia and Asymptomatic Bacteriuria, run by Assiut University.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Percentage of Participants With Asymptomatic Bacteriuria (time frame: Baseline). 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 8 Oct 2026.