Vaginal Microbiota and Post-cesarean SSI

NCT06840041 | Not Yet Recruiting

• 1 other identifier: Obst19225
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

cesarean section; SSI; vaginal microbiota

Outcome Measures

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.

  4 weeks after the surgery.

Secondary Outcomes (1)

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

  6 months

Study Arms (1)

cesarean section group

This observational study will enroll 160 women undergoing cesarean section. Participants will provide vaginal swab samples for culture, both pre-operatively and post-operatively. They will be monitored post-operatively for the development of wound infections, with wound assessments performed according to standard clinical practice. Demographic and clinical data, including antibiotic use, gestational age, and comorbidities, will be collected to assess the relationship between vaginal microbiota and post-cesarean wound infections.

Diagnostic Test: Vaginal swab and culture

Interventions

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

cesarean section group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: This study is exclusively for female participants undergoing cesarean section. Biological females are the only eligible participants due to the focus on vaginal microbiota and its relationship to post-cesarean section wound infections.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• Pregnant women undergoing elective or emergency cesarean section (CS).
• Singleton pregnancy.
• Cesarean section performed at ≥ 37 weeks of gestation.

You may not qualify if:

• Use of antibiotics within two weeks prior to delivery.
• Known immunodeficiency.
• Chronic infections.
• Ruptured membranes for more than 18 hours.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Hussein University Hospital

Cairo, 11633, Egypt

Location

MeSH Terms

Conditions

Wounds and Injuries; Infections

Study Officials

• Muhamed Alhagrasy

  Al-Azhar University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhamed Alhagrasy, M.D.

CONTACT

01017313413; MuhamedAhmed.216@azhar.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer and consultant at Obstetrics and Gynecology Department.

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 21, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 5 years after publication.
• Access Criteria: Access to de-identified Individual Participant Data (IPD) will be granted to qualified researchers with a demonstrated scientific need and a clearly defined research question. Researchers must submit a formal request to MuhamedAhmed.216@azhar.edu.eg, outlining their research proposal, including the specific data requested, the intended use of the data, and their qualifications. Requests will be reviewed by the Department of Obstetrics and Gynecology, Al-Azhar University to ensure scientific merit and ethical compliance. Researchers must agree to sign a data sharing agreement that outlines the terms of data use, including restrictions on redistribution and requirements for appropriate data security and confidentiality.

Locations

EG (1)