Ampicillin/Sulbactam Versus Cefuroxime as Antimicrobial Prophylaxis for Cesarean Section

This study has been completed.
Sponsor:
Information provided by:
Attikon Hospital
ClinicalTrials.gov Identifier:
NCT01138852
First received: June 4, 2010
Last updated: NA
Last verified: July 2004
History: No changes posted

June 4, 2010
June 4, 2010
July 2004
December 2008   (final data collection date for primary outcome measure)
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Not Provided
No Changes Posted
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Ampicillin/Sulbactam Versus Cefuroxime as Antimicrobial Prophylaxis for Cesarean Section
Ampicillin / Sulbactam Versus Cefuroxime as Antimicrobial Prophylaxis for Cesarean Section: a Randomized Study

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Surgical Site Infections
  • 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
  • Experimental: ampicillin-sulbactam
    This is the drug used to prevent post-cesarean infection
    Interventions:
    • Drug: Ampicillin-sulbactam
    • Drug: Cefuroxime
  • Active Comparator: cefuroxime
    This drug was compared to ampicillin sulbactam for prevention of infection
    Interventions:
    • Drug: Ampicillin-sulbactam
    • Drug: Cefuroxime
Ziogos E, Tsiodras S, Matalliotakis I, Giamarellou H, Kanellakopoulou K. Ampicillin/sulbactam versus cefuroxime as antimicrobial prophylaxis for cesarean delivery: a randomized study. BMC Infect Dis. 2010 Nov 30;10:341. doi: 10.1186/1471-2334-10-341.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
176
December 2008
December 2008   (final data collection date for primary outcome measure)

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.
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01138852
UHATpro1
Yes
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
Attikon Hospital
Not Provided
Not Provided
Attikon Hospital
July 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP