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
  Purpose

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.


Condition Intervention Phase
Surgical Site Infections
Drug: Ampicillin-sulbactam
Drug: Cefuroxime
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Ampicillin / Sulbactam Versus Cefuroxime as Antimicrobial Prophylaxis for Cesarean Section: a Randomized Study

Resource links provided by NLM:


Further study details as provided by Attikon Hospital:

Enrollment: 176
Study Start Date: July 2004
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ampicillin-sulbactam
This is the drug used to prevent post-cesarean infection
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
Active Comparator: cefuroxime
This drug was compared to ampicillin sulbactam for prevention of infection
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

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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by Attikon Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: 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
ClinicalTrials.gov Identifier: NCT01138852     History of Changes
Other Study ID Numbers: UHATpro1
Study First Received: June 4, 2010
Last Updated: June 4, 2010
Health Authority: Ethics Committee,Nikaia's Regional General Hospital "Agios Panteleimon" Greece:

Keywords provided by Attikon Hospital:
post-cesarean infections
ampicillin-sulbactam
cefuroxime
cesarean

Additional relevant MeSH terms:
Ampicillin
Cefuroxime
Cefuroxime axetil
Sulbactam
Sultamicillin
Anti-Infective Agents
Anti-Bacterial Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014