Vaginal Microbiota and Post-cesarean SSI

Al-Azhar University

Status: Not yet enrolling

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

Treatments: Diagnostic Test: Vaginal swab and culture

Study type: Observational

Funder types: Other

Identifiers

NCT06840041

Obst19225

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

160 participants in 1 patient group

cesarean section group

Description:

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.

Treatment:

Diagnostic Test: Vaginal swab and culture