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Randomized Controlled Trial
. 2010 Nov 30:10:341.
doi: 10.1186/1471-2334-10-341.

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

Eleftherios Ziogos  1 , Sotirios Tsiodras, Ioannis Matalliotakis, Helen Giamarellou, Kyriaki Kanellakopoulou
Affiliations
Randomized Controlled Trial

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

Eleftherios Ziogos et al. BMC Infect Dis. .

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.

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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).
See this image and copyright information in PMC

References

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