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NCT Number: NCT06840041

Vaginal Microbiota and Post-cesarean SSI

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.

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Key information

Conditions

Site Infection Cesarean Section; Complications, Wound, Infection (Following Delivery) Infections Wounds and Injuries

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Al-Hussein University Hospital

Cairo, 11633, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vaginal swab and culture

Diagnostic Test

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

Primary outcomes

  1. Comparison of Vaginal Microbiota Composition and Surgical Site Infection (SSI) Incidence

    Time frame: 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 outcomes

  1. Predictive Value of Specific Vaginal Bacterial Species for Surgical Site Infection (SSI).

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Muhamed Alhagrasy, M.D.

CONTACT

[email protected]

01017313413

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

The Relationship Between Vaginal Microbiota and Post-Cesarean Section Wound Infection

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 21, 2025
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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