Safety And Efficacy Of Adding Single Dose Adjunctive Azithromycin Prophylaxis For Emergency Cesarean Delivery

Abstract

Introduction Cesarean sections have seen a significant increase in India from 17.2% to 21.5% between 2016 and 2021, driven by factors such as increased maternal requests, physician preference, financial incentives, social-cultural and religious reasons, and fear of legal consequences. These surgeries can be lifesaving but can also lead to adverse health outcomes like maternal infection, uterine bleeding, infant respiratory distress, and hypoglycemia. Surgical site infections (SSI) are a prevalent complication in emergency cesarean sections in India, with a prevalence of 5%-10%. Preventive measures include prophylactic antibiotics, aseptic techniques, early skin-to-skin contact, and breastfeeding. A 2014 Cochrane review found that routine antibiotic prophylaxis reduced wound infection, postpartum endometritis, and maternal severe infectious complications by 60% to 70%. Azithromycin is being researched as a possible preventive measure to decrease SSI during cesarean sections. Aim and objectives of the study The study evaluates the safety and effectiveness of single-dose adjunctive Azithromycin prophylaxis for emergency cesarean delivery. It aims to monitor postoperative complications like endometritis, surgical site infections, fever, skin erythema, re-admissions, and hospital stay duration. Secondary objectives include preventing neonatal complications like sepsis, respiratory distress syndrome, and NICU stay durationMaterials and methods This study was conducted at Shri B.M. Patil Medical College Hospital in Vijaypura, India, involving pregnant women with singleton pregnancies and gestational age of 24 weeks or more in labour. The study included patients undergoing emergency cesarean sections, membrane rupture within 12 hours or PROM, and previous cesarean sections. Exclusion criteria included patients unable to provide consent, known allergies to azithromycin, use of azithromycin 7 days before randomisation, chronic conditions, liver diseases, increased serum creatinine level, dialysis patients, cardiomyopathy, pulmonary oedema, electrolyte abnormalities, pre-eclampsia, and PROM more than 12 hours. The study lasted from September 2022 to March 2024, with 520 participants. Statistical analysis was performed using JMP-SAS Software, with results presented as mean ± S.D., counts and percentages, and diagrams. Comparisons were made using independent t-tests, Mann-Whitney U tests, Chi-square test/Fisher's Exact tests, and regression analysis for relative risk. A p-value of <0.05 was considered statistically significant. Results The study revealed several statistically significant differences between Group A, which received azithromycin before a cesarean section, and Group B, which did not. Postoperative symptoms were one key area where the two groups differed. Group B had significantly higher incidences of erythema (p=0.002), induration (p=0.003), and wound discharge (p=0.025) compared to Group A. These findings suggest that the administration of azithromycin prior to surgery may help reduce the occurrence of these postoperative complicationsFurthermore, the follow-up assessments on the 7th and 14th days after surgery showed that Group A had a significantly higher proportion of normal findings than Group B. At the second follow-up on the 7th day, the difference was statistically significant (p=0.041), indicating that patients who received azithromycin were usually more likely to recover. This trend continued at the third follow-up on the 14th day, with Group A having a significantly higher proportion of normal findings (p=0.023) than Group B. The study also found significant differences in NICU admissions and the need for secondary suturing between the two groups. Group B had a significantly higher percentage of NICU admissions (p=0.024) compared to Group A, suggesting that the use of azithromycin before cesarean section may have a protective effect on newborns. Additionally, Group B had a significantly higher percentage of participants requiring secondary suturing (p=0.048) than Group A, indicating that the antibiotic may help reduce the need for additional surgical interventions post cesarean. Conclusion In conclusion, administering azithromycin before cesarean section in Group A was associated with better postoperative outcomes across several key indicators. The group that received the antibiotic had lower rates of postoperative symptoms, abnormal follow-up findings, NICU admissions, and secondary suturing than the group that did not receive azithromycin. These statistically significant differences highlight the potential benefits of azithromycin prophylactically in cesarean section procedures