Ampicillin/sulbactam versus cefuroxime as antimicrobial prophylaxis for cesarean delivery: a randomized study

Eleftherios Ziogos, Sotirios Tsiodras, Ioannis Matalliotakis, Helen Giamarellou, Kyriaki Kanellakopoulou, Eleftherios Ziogos, Sotirios Tsiodras, Ioannis Matalliotakis, Helen Giamarellou, Kyriaki Kanellakopoulou

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.

Figures

Figure 1
Figure 1
Flow diagram of the study according to the Consort statement.
Figure 2
Figure 2
A schematic diagram of the study according to prophylaxis group, operative risk (high versus low), type of surgery (elective, emergency cesarean delivery) and development of Surgical Site Infection (SSI).

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