Ampicillin/Sulbactam Versus Cefuroxime as Antimicrobial Prophylaxis for Cesarean Section

Overview

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.

Full Title of Study: “Ampicillin / Sulbactam Versus Cefuroxime as Antimicrobial Prophylaxis for Cesarean Section: a Randomized Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 2008

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.

Interventions

  • Drug: Ampicillin-sulbactam
    • 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
  • Drug: Cefuroxime
    • 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

Arms, Groups and Cohorts

  • Experimental: ampicillin-sulbactam
    • This is the drug used to prevent post-cesarean infection
  • Active Comparator: cefuroxime
    • This drug was compared to ampicillin sulbactam for prevention of infection

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Attikon Hospital
  • Provider of Information About this Clinical Study
    • Eleftherios Ziogos, Department of Obstetrics and Gynecology, Nikaia’s Regional General Hospital “Agios Panteleimon”, Pireaus, Department of Obstetrics and Gynecology, Nikaia’s Regional General Hospital “Agios Panteleimon”, Pireaus and Department of Infectious Disease Attikon General Hospital

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