Vaginal Microbiota and Post-cesarean SSI
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-40
SponsorAl-Azhar University
About this trial
The goal of this observational study is to investigate the relationship between vaginal microbiota composition and the development of post-cesarean section wound infection in women undergoing cesarean delivery. The main question it aims to answer is:
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Pregnant women undergoing elective or emergency cesarean section (CS).
Singleton pregnancy.
Cesarean section performed at ≥ 37 weeks of gestation.
Disqualifiers
Use of antibiotics within two weeks prior to delivery.
Known immunodeficiency.
Chronic infections.
Ruptured membranes for more than 18 hours.
Trial population
This study will enroll pregnant women undergoing either elective or emergency cesarean section at or beyond 37 weeks of gestation. Participants must have a singleton pregnancy. Women with known immunodeficiency, chronic infections, or those who have received antibiotics within two weeks prior to delivery will be excluded. Additionally, women with ruptured membranes for more than 18 hours will be excluded to minimize the potential influence of prolonged exposure to mixed flora. The study aims to investigate the relationship between vaginal microbiota and post-cesarean section wound infection within this defined population.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Vaginal swab and culture
Diagnostic testParticipants 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
Treatment groups
160 Participants
are divided into 1 treatment groupGroup A: cesarean section group1 intervention
Trial outcomes
Primary outcomes
1
Comparison of Vaginal Microbiota Composition and Surgical Site Infection (SSI) Incidence
This outcome will assess the differences in vaginal microbiota composition between women who develop a surgical site infection (SSI) following cesarean section and those who do not. Microbiota composition will be determined through culture and analysis of vaginal swab samples collected pre-operatively and post-operatively. Comparisons will focus on identifying significant variations in bacterial taxa, diversity indices, and overall microbial community structure between the two groups.
Time frame
4 weeks after the surgery.Secondary outcomes
1
Predictive Value of Specific Vaginal Bacterial Species for Surgical Site Infection (SSI).
This outcome will evaluate the ability of specific bacterial species identified in vaginal swab samples to predict the development of surgical site infection (SSI) following cesarean section. Logistic regression analysis will be used to determine the independent predictive value of individual bacterial species, as well as combinations of species, for SSI. The analysis will assess the odds ratios, confidence intervals, and p-values associated with each bacterial species.
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: