Ampicillin/sulbactam versus cefotetan for the prevention of infection following cesarean delivery in high-risk patients: a randomized double-blind trial.

The objective of this study was to compare the efficacy and safety of a single intravenous dose of 1 g ampicillin plus 0.5 g sulbactam to a single intravenous dose of 1 g cefotetan in the prevention of postoperative infection following cesarean delivery in high-risk patients. In this single-center comparative study, women who were to undergo cesarean delivery and who were at high risk of developing postoperative infection were randomized into two treatment groups. At the time the umbilical cord was clamped, one group was treated intravenously with 1 g ampicillin plus 0.5 g sulbactam, and the other was treated intravenously with 1 g cefotetan. The two groups were evaluated for evidence of postoperative infections and adverse experiences. A total of 170 women who were at high risk of developing postoperative infection following cesarean delivery (87 in the ampicillin/sulbactam group and 83 in the cefotetan group) were analyzed. Successful prophylaxis, absence of any infection including absence of febrile morbidity with no other symptoms, was reported in 69 of 87 (79%) patients receiving ampicillin/sulbactam and in 60 of 83 (72%) patients receiving cefotetan. One patient in each group had an infection at the incision site. There were no statistically significant differences in the rates of endometritis or urinary tract infections. The mean duration of hospitalization was 5.5 days for patients receiving ampicillin/sulbactam and 5.7 days for patients receiving cefotetan. A single intravenous dose of the combination of ampicillin/sulbactam was as safe and effective as a single intravenous dose of cefotetan when administered for the prevention of infections following cesarean delivery in patients at high risk of developing postoperative morbidity. Both antibiotics were safe and well tolerated with no unusual or unexpected events.