Ampicillin/Sulbactam Versus Cefuroxime as Antimicrobial Prophylaxis for Cesarean Section
- Conditions
- Surgical Site Infections
- Interventions
- Registration Number
- NCT01138852
- Lead Sponsor
- Attikon Hospital
- Brief Summary
The efficacy and safety of a single dose of ampicillin/sulbactam compared to a single dose of cefuroxime at cord clamp for prevention of postcesarean infectious morbidity has not been assessed.
Women scheduled for cesarean delivery were randomized to receive a single dose of either 3g of ampicillin-sulbactam or 1.5g of cefuroxime intravenously, after umbilical cord clamping. An evaluation for development of postoperative infections and risk factor analysis was performed.
- Detailed Description
The efficacy and safety of a single dose of ampicillin/sulbactam compared to a single dose of cefuroxime at cord clamp for prevention of postcesarean infectious morbidity has not been assessed.
The investigation was designed to evaluate the efficacy and safety of a single dose of ampicillin/sulbactam 3g compared to a single dose of cefuroxime 1.5g in preventing postoperative morbidity. The primary outcome was development of an infection either at the surgical site or elsewhere e.g. urinary tract infection.
A prospective randomized controlled study was performed from July 2004 to December 2008 in one major tertiary care hospital in Athens Greece. All patients undergoing a cesarean delivery were eligible.Patients were randomly assigned to receive either 1.5g of cefuroxime, or 3g of ampicillin/ sulbactam intravenously after the time the umbilical cord was clamped.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 176
- All patients undergoing a cesarean delivery were eligible.
- Patients with known hypersensitivity to penicillin or cephalosporins.
- Patients who required concomitant antibiotic therapy during surgery.
- Patients who have received antibiotics during the 72 hours immediately preceding their enrollment.
- Patients whose postpartum fever was clearly associated with other known causes.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ampicillin-sulbactam Ampicillin-sulbactam This is the drug used to prevent post-cesarean infection cefuroxime Ampicillin-sulbactam This drug was compared to ampicillin sulbactam for prevention of infection ampicillin-sulbactam Cefuroxime This is the drug used to prevent post-cesarean infection cefuroxime Cefuroxime This drug was compared to ampicillin sulbactam for prevention of infection
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method