OBJECTIVE: To determine the effectiveness and safety of the routine use of antibiotic prophylaxis in women undergoing cesarean section. METHOD: Four hundred and forty-one women undergoing cesarean sections were randomly assigned either to a single dose of 1 g intravenous cefazolin or placebo after clamping of the umbilical cord. The primary outcome was the development of post-operative febrile morbidity and the secondary outcomes were infection-related complications. RESULT: There were 211 emergency and 230 elective cesarean sections. In the emergency cesarean sections, 34 (30.6%) women developed post-operative febrile morbidity in the placebo group compared to 11 (11%) women in the cefazolin group. This was a statistically significant difference (P = 0.001). Similarly, there were statistically significant differences between the two groups in the development of wound infection (P<0.001), use of therapeutic antibiotics (P = 0.001), and post-operative days in hospital (P = 0.003). No statistically significant differences were detected in the development of other infection-related complications. In the elective cesarean sections, no statistically significant differences were found in post-operative febrile morbidity and infection-related complications. There were no serious side effects related to the use of cefazolin. CONCLUSION: The routine use of a single dose of cefazolin is safe and effective in emergency but not elective cesarean section.
RCT Entities:
OBJECTIVE: To determine the effectiveness and safety of the routine use of antibiotic prophylaxis in women undergoing cesarean section. METHOD: Four hundred and forty-one women undergoing cesarean sections were randomly assigned either to a single dose of 1 g intravenous cefazolin or placebo after clamping of the umbilical cord. The primary outcome was the development of post-operative febrile morbidity and the secondary outcomes were infection-related complications. RESULT: There were 211 emergency and 230 elective cesarean sections. In the emergency cesarean sections, 34 (30.6%) women developed post-operative febrile morbidity in the placebo group compared to 11 (11%) women in the cefazolin group. This was a statistically significant difference (P = 0.001). Similarly, there were statistically significant differences between the two groups in the development of wound infection (P<0.001), use of therapeutic antibiotics (P = 0.001), and post-operative days in hospital (P = 0.003). No statistically significant differences were detected in the development of other infection-related complications. In the elective cesarean sections, no statistically significant differences were found in post-operative febrile morbidity and infection-related complications. There were no serious side effects related to the use of cefazolin. CONCLUSION: The routine use of a single dose of cefazolin is safe and effective in emergency but not elective cesarean section.