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NCT01138852 Clinical Trial

Ampicillin/Sulbactam Versus Cefuroxime as Antimicrobial Prophylaxis for Cesarean Section

Surgical Site Infections Clinical Trial

Official title:
Ampicillin / Sulbactam Versus Cefuroxime as Antimicrobial Prophylaxis for Cesarean Section: a Randomized Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01138852
Other study ID # UHATpro1
Secondary ID
Status Completed
Phase Phase 4
First received June 4, 2010
Last updated June 4, 2010
Start date July 2004
Est. completion date December 2008

Study information
Verified date July 2004
Source Attikon Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 176
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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
• 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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Attikon Hospital
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