Antimicrobial Prophylaxis in Lower Uterine Segment Caesarean Section: A Prospective Observational Data-based Study

Introduction: Any major surgery like lower uterine Caesarean Section (CS) can be hazardous due to postoperative nosocomial infection. Pregnant mothers are at greater risk during such surgical intervention as compared to vaginal delivery. Prophylactic antibiotic administration is a standard practice across the globe to prevent such anticipated postoperative infection. Aim: To evaluate the prophylactic antimicrobial use with regards to the choice of antimicrobials, dose, route, timing and duration, any possible Adverse Drug Reaction (ADR) as well as to assess the frequency of the postoperative morbidity due to infection (if any). Materials and Methods: A prospective observational data-based study was conducted in the Department of Pharmacology in collaboration with Department of Obstetrics and Gynaecology, Burdwan Medical College and Hospital, Burdwan, West Bengal, India, from February 2016 to October 2017. Study was conducted on 1944 pregnant women of reproductive age group planned or scheduled for elective/emergency lower segment CS, but otherwise healthy and received prophylactic antimicrobials for the surgery. They were prospectively observed regarding the treatment they received with focus on antimicrobial agents from the period of antimicrobial prophylaxis during their stay at hospital to till their discharge. Demographic data, vital signs, indication of CS, postoperative infections and ADR if any were recorded in predesigned proforma. The study population was divided into two groups: group A included 995 mothers, who received ceftriaxone sodium (1 g intravenously) and metronidazole (15 mg/kg) infusion and group B included 949 mothers, who received ampicillin (2 g intravenously), metronidazole (15 mg/kg) infusion and injection gentamycin (5 mg/kg) for 0.5 hour before initiation of CS. The data were statistically analysed by standard statistical software Microsoft Excel 2010 and Statistical Package for the Social Sciences (SPSS) sotware version 27.0 (SPSS Inc., Chicago, IL, USA) expressed as mean and standard deviation and percentage. Independent t- test and Chi-square test were used for analysis. Results: The mean age of group A was 22.36±3.07 years and group B was 22.76±2.47 years. Endomyometritis was documented in 4 (0.4%) from group A and 2 (0.21%) from the group B. Wound infection was present in 3 (0.3%) for group A and five (0.5%) for the group B. Infection related complications like chest infection seen in 7 (0.7%) for group A and in 3 (0.31%) for group B and urinary tract infection was noticed in 6 (0.6%) for group A and 5 (0.52%) for group B. Any incidence of maternal mortality was not evident among the two study groups and statistically insignificant ADR like vomiting and maculopapular rash (p-value=0.324) was observed in both the study groups with the use of above-mentioned antimicrobial therapy. Conclusion: Prophylactic use of ceftriaxone plus metronidazole and combination of triple antimicrobial therapy of ampicillin, metronidazole, and gentamycin therapy at the usual standard dose were commonly used antimicrobials at the present set up and they are safe and equally effective in decreasing considerably the incidence of post caesarean maternal infection thereby reducing their morbidity and mortality.