Single vs Multiple Antibiotic Drug Regimen in Preventing Infectious Morbidity in Caesarean Section: A Randomised Clinical Trial

Abstract

Introduction: Surgical site infections are a serious cause of maternal morbidity and mortality. Various preventive measures are being used to reduce the incidence of surgical site infections. One of them is the use of prophylactic antibiotics. In this study, authors have evaluated three antibiotic regimen with respect to preventing infectious morbidity in caesarean section. Aim: To study the efficacy and cost-effectiveness of a single dose (ceftriaxone) versus multiple doses of antibiotic therapy (ceftriaxone and ornidazole) administered preoperatively in women undergoing caesarean delivery. Materials and Methods: A prospective interventional study was conducted on 300 pregnant women undergoing emergency or elective caesarean delivery. Study was conducted at BLDE (DU) Shri BM Patil Medical College and Research Centre, Vijayapur, Karnataka, India. Patients were randomly assigned to three groups by block random sampling with 100 women in each group. Group A received Inj. ceftriaxone 1 gm single dose 60 minutes prior to commencement of surgery. Group B received Inj. ceftriaxone 1 gm along with Inj. ornidazole 500 mg intravenous infusion 60 minutes prior to commencement of surgery and Group C received Inj. ceftriaxone 1 gm and Inj. ornidazole 500 mg intravenous infusion 60 minutes prior to commencement of surgery and a repeat dose 12th hourly for 24 hours followed by Tab. cefixime 200 mg and Tab. ornidazole 500 mg twice daily for four days postoperatively. The effectiveness of therapy was measured in terms of adverse effects of antibiotics such as nausea and vomiting and postoperative complications like pyrexia, foul smelling lochia, surgical site infections, uterine tenderness, peritonitis and endometritis. Results: There was no statistical difference in outcome measures in side-effects of antibiotics (p-value=0.13), fever (p-value=0.68), lochia discharge (p-value=0.88), wound infection (p-value=0.39) and peritonitis (p-value=0.30) among the three groups. The single dose medication in group A had a cost of Rs.60 INR (0.82 cents USD), which was significantly less compared to the multiple dose regimens in group B that cost Rs.203 INR ($2.76 USD). The mean hospital stay in non infectious and infectious patients were 5 and 10 days in present study (p<0.0001). Conclusion: Caesarean delivery poses 5-20 times greater risk of postoperative infection when compared to vaginal birth. There has been a shifting trend of increasing caesarean deliveries and postoperative infections can contribute to overwhelming health and economic burden. Present study shows outcome measures which were statistically insignificant among the three study groups with different prophylactic regimen for caesarean delivery, so it’s safe to state that both single dose and multiple dose regimen provided equal protective coverage in reducing maternal infectious morbidity. Also, single dose regimen proved to be cost-effective. So, to conclude single dose prophylactic antibiotic given preoperatively in caesarean section is both cost-effective and as is efficient.