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Ampicillin/Sulbactam Versus Cefuroxime as Antimicrobial Prophylaxis for Cesarean Section

Primary Purpose

Surgical Site Infections

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Ampicillin-sulbactam

Cefuroxime

About this trial

This is an interventional prevention trial for Surgical Site Infections focused on measuring post-cesarean infections, ampicillin-sulbactam, cefuroxime, cesarean

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ampicillin-sulbactam

cefuroxime

Arm Description

This is the drug used to prevent post-cesarean infection

This drug was compared to ampicillin sulbactam for prevention of infection

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT01138852

First Posted

June 4, 2010

Last Updated

June 4, 2010

Sponsor

Attikon Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01138852

Brief Title

Ampicillin/Sulbactam Versus Cefuroxime as Antimicrobial Prophylaxis for Cesarean Section

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2004

Overall Recruitment Status

Completed

Study Start Date

July 2004 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Attikon Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Surgical Site Infections

Keywords

post-cesarean infections, ampicillin-sulbactam, cefuroxime, cesarean

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

176 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ampicillin-sulbactam

Arm Type

Experimental

Arm Description

This is the drug used to prevent post-cesarean infection

Arm Title

cefuroxime

Arm Type

Active Comparator

Arm Description

This drug was compared to ampicillin sulbactam for prevention of infection

Intervention Type

Drug

Intervention Name(s)

Ampicillin-sulbactam

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Cefuroxime

Intervention Description

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

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility 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.

12. IPD Sharing Statement

Citations:

PubMed Identifier

33661539

Citation

Williams MJ, Carvalho Ribeiro do Valle C, Gyte GM. Different classes of antibiotics given to women routinely for preventing infection at caesarean section. Cochrane Database Syst Rev. 2021 Mar 4;3(3):CD008726. doi: 10.1002/14651858.CD008726.pub3.

Results Reference

derived

PubMed Identifier

21118502

Citation

Ziogos E, Tsiodras S, Matalliotakis I, Giamarellou H, Kanellakopoulou K. Ampicillin/sulbactam versus cefuroxime as antimicrobial prophylaxis for cesarean delivery: a randomized study. BMC Infect Dis. 2010 Nov 30;10:341. doi: 10.1186/1471-2334-10-341.

Results Reference

derived

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Ampicillin/Sulbactam Versus Cefuroxime as Antimicrobial Prophylaxis for Cesarean Section

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