Ampicillin/Sulbactam Versus Cefuroxime as Antimicrobial Prophylaxis for Cesarean Section
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| ClinicalTrials.gov Identifier: NCT01138852 |
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Recruitment Status :
Completed
First Posted : June 7, 2010
Last Update Posted : June 7, 2010
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Surgical Site Infections | Drug: Ampicillin-sulbactam Drug: Cefuroxime | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 176 participants |
| 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 |
| Study Start Date : | July 2004 |
| Actual Primary Completion Date : | December 2008 |
| Actual Study Completion Date : | December 2008 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: ampicillin-sulbactam
This is the drug used to prevent post-cesarean infection
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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 |
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Active Comparator: cefuroxime
This drug was compared to ampicillin sulbactam for prevention of infection
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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 |
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| 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.
| 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 |
| Other Study ID Numbers: |
UHATpro1 |
| First Posted: | June 7, 2010 Key Record Dates |
| Last Update Posted: | June 7, 2010 |
| Last Verified: | July 2004 |
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post-cesarean infections ampicillin-sulbactam cefuroxime cesarean |
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Surgical Wound Infection Infections Wound Infection Postoperative Complications Pathologic Processes Ampicillin Cefuroxime Cefuroxime axetil |
Sulbactam Sultamicillin Anti-Bacterial Agents Anti-Infective Agents beta-Lactamase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |