Results of a randomized, multicenter, comparative trial of a single dose of cefotetan versus multiple doses of cefoxitin as prophylaxis in cesarean section

Abstract

In a multicenter, open, randomized, comparative trial, 308 women undergoing cesarean section were given a single 1 gm dose of cefotetan or three 2 gm doses of cefoxitin after cord clamping to reduce the incidence of postoperative infectious morbidity. Of the 286 evaluable patients, 195 received cefotetan and 91 received cefoxitin. Most patients were in active labor and one third had ruptured membranes. Microorganisms cultured from the endocervix or intraoperatively from the endometrium or abdominal wall operative sites were comparable for the two groups. In this multicenter study, the difference between the percentage of patients receiving cefotetan who did not develop clinical signs and symptoms of infection (93%) and the percentage of patients receiving cefoxitin (85%) considered clinical successes was statistically significant (p = 0.02, chi 2). The bacteriologic response rate for patients taking cefotetan was also significantly higher than that for patients taking cefoxitin (93% versus 85%, p = 0.03). Isolates recovered from the endocervix, endometrium, or operative site were comparable for the two groups. Both drugs were well tolerated. In this evaluation, cefotetan administered in a single dose of 1 gm was more effective as a prophylactic agent than multiple 2 gm doses of cefoxitin in the reduction of infectious morbidity in this large series of patients undergoing cesarean section.