Ampicillin/Sulbactam Versus Cefuroxime as Antimicrobial Prophylaxis for Cesarean Section

NCT01138852 | Completed Phase 4 DMC

• 1 other identifier: UHATpro1
• Study Type: interventional
• Target: 176
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Surgical Site Infections

Keywords

post-cesarean infections; ampicillin-sulbactam; cefuroxime; cesarean

Study Arms (2)

ampicillin-sulbactam

EXPERIMENTAL

This is the drug used to prevent post-cesarean infection

Drug: Ampicillin-sulbactam; Drug: Cefuroxime

cefuroxime

ACTIVE COMPARATOR

This drug was compared to ampicillin sulbactam for prevention of infection

Drug: Ampicillin-sulbactam; Drug: Cefuroxime

Interventions

Ampicillin-sulbactam DRUG

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

ampicillin-sulbactam; cefuroxime

Cefuroxime DRUG

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

ampicillin-sulbactam; cefuroxime

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- All patients undergoing a cesarean delivery were eligible.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Attikon Hospital: lead

Related Publications (2)

• 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.

  PMID: 33661539 DERIVED

• 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.

  PMID: 21118502 DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

sultamicillin; Cefuroxime

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 4, 2010
• First Posted: June 7, 2010
• Study Start: July 1, 2004
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 7, 2010

Record last verified: 2004-07