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Starting soon Observational

Vaginal Microbiota and Post-cesarean SSI

NCT06840041 · tracked via the Priya Life Science Egypt tracker
Phase
Observational
Started
2025-06-30
Last updated
2025-06-15

Condition(s) studied

Site InfectionCesarean Section; Complications, Wound, Infection (Following Delivery)

Investigational drug(s) / intervention(s)

Vaginal swab and culture

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

Study summary

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

Sex
FEMALE
Min age
18 Years
Max age
40 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Pregnant women undergoing elective or emergency cesarean section (CS). * Singleton pregnancy. * Cesarean section performed at ≥ 37 weeks of gestation. Exclusion Criteria: * Use of antibiotics within two weeks prior to delivery. * Known immunodeficiency. * Chronic infections. * Ruptured membranes for more than 18 hours.

Primary outcome measure(s)

  • Comparison of Vaginal Microbiota Composition and Surgical Site Infection (SSI) Incidence — 4 weeks after the surgery.
    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.

Trial sites (1)

FacilityCityRegionStatus
Al-Hussein University Hospital Cairo Egypt

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06840041 on ClinicalTrials.gov ↗ ← All trials in Egypt