Prophylactic Antibiotics After Cesarean
Completed · Phase 1 · Has a placebo group
Conditions studied: Surgical Site Infection
In brief
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.
Key facts
- Study ID
- NCT03187106
- Run by
- The University of Texas Medical Branch, Galveston
- People needed
- 321
- Starts
- 2017-08-01
- Expected to finish
- 2023-07-21
- Last updated by the study team
- 2023-08-16
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- St. David's North Austin Medical Center — Austin, Texas, United States
- University of Texas Medical Branch John Sealy Hospital — Galveston, Texas, United States
Full record on ClinicalTrials.gov
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