Conditions: Endometritis Wound Infection Abscess Surgical Site Infection
Keywords: Pregnancy Cesarean section Antibiotic Infections
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2013
Healthy volunteers: no

Brief summary:
The Cesarean Section Optimal Antibiotic Prophylaxis (C/SOAP) study is a large pragmatic multi-center randomized clinical trial designed to evaluate the comparative effectiveness and safety of azithromycin-based extended-spectrum antibiotic prophylaxis (azithromycin plus standard narrow-spectrum cephalosporin) relative to standard single-agent cephalosporin (preferably prior to surgical incision) to prevent post-cesarean infection.

Hypothesis: Compared to narrow-spectrum prophylaxis (i.e. cefazolin alone, or clindamycin if cephalosporin allergy) prior to surgical incision, the addition of extended-spectrum prophylaxis (azithromycin + cefazolin) reduces the incidence of post-cesarean infection.

Detailed description:

Arms:
arm 1: 250 cc normal saline arm 2: 500 mg Azithromycin in 250 cc normal saline

Interventions: intervention 1: Azithromycin and standard of care intervention 2: Placebo and standard of care
Intervention descriptions: intervention 1: 500 mg in 250 cc normal saline 1 time dose plus standard of care (cephazolin or clindamycin) intervention 2: 250 cc normal saline, plus standard of care (cephazolin or clindamycin)

Protocol document: