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Vaginal Microbiota and Post-cesarean SSI

NCT06840041 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 160

Last updated 2025-06-15

No results posted yet for this 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.

Conditions

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

Interventions

DIAGNOSTIC_TEST

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

Sponsors & Collaborators

  • Al-Azhar University

    lead OTHER

Principal Investigators

  • Muhamed Alhagrasy · Al-Azhar University

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2026-06-30
Completion
2026-07-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06840041 on ClinicalTrials.gov