A randomized control trial of single dose versus multiple doses of IV antibiotic prophylaxis in caesarean delivery

Abstract

Objectives To determine the effectiveness and safety of single doses antibiotic against conventional multiple doses regimen on clinically detectable maternal and neonatal infectious morbidity. Method This is a randomized, non-blind clinical trial on women undergoing caesarean section. By block random sampling, 369 women, who were enrolled in this study, 185 (50.1%) randomly received single dose of antibiotics and 184 (49.8%) received multiple postoperative doses of antibiotics. All potentially infected cases were excluded. These patients were followed up prospectively for infectious and neonatal complications till discharge and verbal enquiry or direct observation done during suture removal. The effectiveness was measured in terms of febrile morbidity, surgical site infection, endometritis, urinary tract infection, other infection along with duration of hospital stay. Chi-square analysis (Fisher’s Exact Test) of variance were performed with equivalence margin was set at 5% (p value). Results The incidence rates of post-caesarean infections were 1.8% and 3.2% in single dose and multiple dose regimens respectively with the incidence rate ratio of 0.3 [95% CI 0.065-1.63) p-value=0.284]. There were no statistically significant differences in febrile morbidity (p=0.28), wound infections (p=0.123), perinatal outcome (p> 0.05) and median duration of hospital stay (p=0.329) in both arms. Conclusions Single combined prophylactic antibiotic usage immediately after cord clamping is equally effective as multiple conventional regimen following the caesarean deliveries in prevention of infectious morbidities and duration of hospital stay, with benefit of reducing staff workload along with reduced medication costs and the emergence of drug selective resistant bacteria.