Ampicillin/Sulbactam Versus Cefuroxime as Antimicrobial Prophylaxis for Cesarean Section

Attikon University Hospital

Status and phase: Completed; Phase 4

Conditions: Surgical Site Infections

Treatments: Drug: Ampicillin-sulbactam; Drug: Cefuroxime

Study type: Interventional

Funder types: Other

Identifiers

NCT01138852

UHATpro1

Details and patient eligibility

About

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 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.

Enrollment: 176 patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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176 participants in 2 patient groups

ampicillin-sulbactam

Experimental group

Description:

This is the drug used to prevent post-cesarean infection

Treatment:

Drug: Cefuroxime

Drug: Ampicillin-sulbactam

cefuroxime

Active Comparator group

Description:

This drug was compared to ampicillin sulbactam for prevention of infection

Treatment:

Drug: Cefuroxime

Drug: Ampicillin-sulbactam