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Ampicillin/Sulbactam Versus Cefuroxime as Antimicrobial Prophylaxis for Cesarean Section
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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 Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Prevention |
| Official Title: | Ampicillin / Sulbactam Versus Cefuroxime as Antimicrobial Prophylaxis for Cesarean Section: a Randomized Study |
| 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| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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 LocationsNo Contacts or Locations Provided
More Information
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 |
Keywords provided by Attikon Hospital:
|
post-cesarean infections ampicillin-sulbactam cefuroxime cesarean |
Additional relevant MeSH terms:
|
Surgical Wound Infection Wound Infection Infection Postoperative Complications Pathologic Processes Cefuroxime axetil Sultamicillin Anti-Infective Agents |
Ampicillin Cefuroxime Sulbactam Anti-Bacterial Agents beta-Lactamase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 20, 2017