Vaginal Microbiota and Post-cesarean SSI

Not yet recruiting

• Conditions: Site Infection; Cesarean Section; Complications, Wound, Infection (Following Delivery)

• Registration Number: NCT06840041
• Lead Sponsor: Al-Azhar University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-18
• Study First Submitted QC: 2025-02-18
• Last Update Submitted: 2025-02-18
• Study First Posted: 2025-02-21
• Last Update Posted: 2025-02-21
• Study Start: 2025-03-15
• Primary Completion: 2025-12-30
• Study Completion: 2026-01-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 160

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Predictive Value of Specific Vaginal Bacterial Species for Surgical Site Infection (SSI).	6 months	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.

Trial Locations

Locations (1)

Al-Hussein University Hospital; 🇪🇬 Cairo, Egypt