Oral versus intravenous antibiotic prophylaxis before obstetric and gynecological surgical interventions: A randomized clinical trial

Objective

The current study was conducted to compare the efficacy of prophylactic intravenous versus oral (Cephradin) for the prevention of surgical site infections (SSI) in Obstetric and Gynecological interventions.

Methods

A randomized clinical trial was carried out on 230 patients fulfilling the eligibility criteria between 1st October 2023 and 31st July 2024, including pregnant women who were approached prior to their delivery and non-pregnant women who were approached prior to their intended interventions. (group A) 116 patients received oral antimicrobial prophylaxis, while (group B) 114 patients received intravenous antimicrobial prophylaxis. Furthermore, all included patients received oral antibiotics postoperatively (oral cephradine 500 mg/ 12 h for 7 days). Patients were evaluated twice; the 1st assessment was done 1 week, while the 2nd assessment was done a month after the intervention.

Results

SSI rate was 14 % CI (0.07–0.20) in the oral group compared to 13 % CI (0.07–0.20) in the intravenous group after one week with no significant difference in between (p = 0.84). However, the SSI rate was 5.5 % CI (0.02–0.11) in the oral group compared to 6.3 % CI (0.02–0.12) in the intravenous group after one month of the intervention, with no significant difference in between (p = 0.78).

Conclusion

The current study showed that oral antibiotic prophylaxis before obstetric and gynecological interventions seems to be safe, easy, practical, cheap, and as effective as parenteral antibiotic prophylaxis in the prevention of SSI. However, more randomized trials with larger sample sizes are needed to pave the way for replacing parenteral with oral antibiotic chemoprophylaxis.

Trial registration: The study was approved by the Sohag Ethical Committee, Faculty of Medicine, with IRB number (Soh-Med-23-09-05MS) and was registered on clinical trial.gov with T.R.N (NCT06255652).