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.

Abstract

Background: The efficacy and safety of a single dose of ampicillin/sulbactam compared to a single dose of cefuroxime at cord clamp for prevention of post-cesarean infectious morbidity has not been assessed.

Methods: Women scheduled for cesarean delivery were randomized to receive a single dose of either 3 g of ampicillin-sulbactam or 1.5 g of cefuroxime intravenously, after umbilical cord clamping. An evaluation for development of postoperative infections and risk factor analysis was performed.

Results: One hundred and seventy-six patients (median age 28 yrs, IQR: 24-32) were enrolled in the study during the period July 2004-July 2005. Eighty-five (48.3%) received cefuroxime prophylaxis and 91 (51.7%) ampicillin/sulbactam. Postoperative infection developed in 5 of 86 (5.9%) patients that received cefuroxime compared to 8 of 91 (8.8%) patients that received ampicillin/sulbactam (p=0.6). In univariate analyses 6 or more vaginal examinations prior to the operation (p=0.004), membrane rupture for more than 6 hours (p=0.08) and blood loss greater than 500 ml (p=0.018) were associated with developing a postoperative surgical site infection (SSI). In logistic regression having 6 or more vaginal examinations was the most significant risk factor for a postoperative SSI (OR 6.8, 95% CI: 1.4-33.4, p=0.019). Regular prenatal follow-up was associated with a protective effect (OR 0.04, 95% CI: 0.005-0.36, p=0.004).

Conclusions: Ampicillin/sulbactam was as safe and effective as cefuroxime when administered for the prevention of infections following cesarean delivery.

Trial registration: Clinicaltrials.gov identifier: NCT01138852.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Ampicillin / therapeutic use*
  • Anti-Infective Agents / therapeutic use*
  • Antibiotic Prophylaxis*
  • Cefuroxime / therapeutic use*
  • Cesarean Section*
  • Female
  • Humans
  • Postoperative Complications / prevention & control
  • Pregnancy
  • Prospective Studies
  • Puerperal Infection / prevention & control
  • Risk Factors
  • Sulbactam / therapeutic use*
  • Young Adult

Substances

  • Anti-Infective Agents
  • Ampicillin
  • Cefuroxime
  • Sulbactam

Associated data

  • ClinicalTrials.gov/NCT01138852