Prophylactic Antibiotics After Cesarean

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine if the addition of a 48-hour course of post-operative antibiotics to the recommended course of pre-operative antibiotics improves surgical site infection rate in patients who are obese and undergo Cesarean section after laboring.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Medical Branch, Galveston
• Treatments: Anti-Bacterial Agents; Cephalexin; Metronidazole

Criteria

Inclusion Criteria:

• Women >18 and <50 years

• BMI >30kg/m2

• Decision by clinical team to perform Cesarean section

• Rupture of membranes (ROM) < 24 hours after onset of labor or during the course of labor (ROM defined by spontaneous or artificial rupture of the amniotic sac)

Exclusion Criteria:

• Subject unwilling or unable to provide consent

• No prenatal care or a non-UTMB subject who is unlikely to be followed up after delivery

• Fetal demise or major congenital anomaly

• Immunosuppressed subjects: i.e., taking systemic immunosuppressants or steroids (e.g. transplant subjects; not including steroids for lung maturity), HIV with CD4<200, or other

• Diagnosis or suspicion of chorioamnionitis prior to randomization

• Other planned post-operative antibiotic administration

• High likelihood of additional surgical procedure beyond cesarean (e.g. scheduled hysterectomy, bowel or adnexal surgery)

• Known allergy or contraindication to cephalosporins or metronidazole

• Incarcerated individuals