Vaginal Microbiota and Post-cesarean SSI

NCT ID: NCT06840041

Last Updated: 2025-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-30

Study Completion Date

2026-07-30

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Vaginal swab and culture

Intervention Type 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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy

lecturer and consultant at Obstetrics and Gynecology Department.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Muhamed Alhagrasy

Role: PRINCIPAL_INVESTIGATOR

Al-Azhar University

Locations

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Al-Hussein University Hospital

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Muhamed Alhagrasy, M.D.

Role: CONTACT

01017313413

Other Identifiers

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Obst19225

Identifier Type: -

Identifier Source: org_study_id

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