Ampicillin/Sulbactam Versus Cefuroxime as Antimicrobial Prophylaxis for Cesarean Section
Information source: Attikon Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Surgical Site Infections
Intervention: Ampicillin-sulbactam (Drug); Cefuroxime (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Attikon Hospital
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.
Clinical Details
Official title: Ampicillin / Sulbactam Versus Cefuroxime as Antimicrobial Prophylaxis for Cesarean Section: a Randomized Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- All patients undergoing a cesarean delivery were eligible.
Exclusion Criteria:
- 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.
Locations and Contacts
Additional Information
Starting date: July 2004
Last updated: June 4, 2010
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