Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
160 participants
OBSERVATIONAL
2025-06-30
2026-07-30
Brief Summary
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Is there a correlation between specific vaginal microbiota profiles and the incidence of post-cesarean section wound infection? Can specific bacterial taxa or diversity indices within the vaginal microbiota predict the risk of post-cesarean section wound infection?
Participants will:
Provide vaginal swab samples pre-operatively and post-operatively. Undergo standard post-cesarean section care and follow-up. Have wound assessment performed per standard of care, and have data collected regarding wound infection status.
Have demographic and clinical data collected, including but not limited to, antibiotic use, gestational age, and comorbidities.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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cesarean section group
This observational study will enroll 160 women undergoing cesarean section. Participants will provide vaginal swab samples for culture, both pre-operatively and post-operatively. They will be monitored post-operatively for the development of wound infections, with wound assessments performed according to standard clinical practice. Demographic and clinical data, including antibiotic use, gestational age, and comorbidities, will be collected to assess the relationship between vaginal microbiota and post-cesarean wound infections.
Vaginal swab and culture
Participants will undergo vaginal swab collection both pre-operatively, immediately prior to the cesarean section, and post-operatively, within a defined timeframe after the procedure. The swabs will be collected using sterile swabs, following standardized procedures to ensure accurate sampling of the vaginal microbiota. The collected samples will then be sent to a designated laboratory for culture and analysis. This process will identify and characterize the bacterial composition of the vaginal microbiota, allowing researchers to investigate potential correlations between specific microbial profiles and the development of post-cesarean section wound infections
Interventions
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Vaginal swab and culture
Participants will undergo vaginal swab collection both pre-operatively, immediately prior to the cesarean section, and post-operatively, within a defined timeframe after the procedure. The swabs will be collected using sterile swabs, following standardized procedures to ensure accurate sampling of the vaginal microbiota. The collected samples will then be sent to a designated laboratory for culture and analysis. This process will identify and characterize the bacterial composition of the vaginal microbiota, allowing researchers to investigate potential correlations between specific microbial profiles and the development of post-cesarean section wound infections
Eligibility Criteria
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Inclusion Criteria
* Singleton pregnancy.
* Cesarean section performed at ≥ 37 weeks of gestation.
Exclusion Criteria
* Known immunodeficiency.
* Chronic infections.
* Ruptured membranes for more than 18 hours.
18 Years
40 Years
FEMALE
Yes
Sponsors
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Al-Azhar University
OTHER
Responsible Party
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Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy
lecturer and consultant at Obstetrics and Gynecology Department.
Principal Investigators
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Muhamed Alhagrasy
Role: PRINCIPAL_INVESTIGATOR
Al-Azhar University
Locations
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Al-Hussein University Hospital
Cairo, , Egypt
Countries
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Central Contacts
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Other Identifiers
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Obst19225
Identifier Type: -
Identifier Source: org_study_id
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