Comparison of Single versus Multiple Doses of Amoxicillin/Clavulanic Acid for Antimicrobial Prophylaxis in Caesarean Section: A Randomised Controlled Trial at Federal Teaching Hospital, Gombe, Nigeria

Abstract

OBJECTIVE: To compare the efficacy of single-dose antimicrobial prophylaxis (AMP) with multiple doses for caesarean section (CS) at Federal Teaching Hospital Gombe. SUBJECTS AND METHODS: Parallel arm randomised controlled trial (1:1 allocation) comparing single and multiple dose AMP for CS. Federal Teaching Hospital Gombe, Nigeria. One hundred and seventy-six women undergoing elective and emergency CSs. Participants were randomised into two groups: single dose of intravenous amoxicillin/clavulanic acid before skin incision only (Group A) and multiple doses including post-operative doses (Group B). Surgical site infection (SSI) rate during a 30-day surveillance period. RESULTS: The SSI rate was 2.3% in Group A and 0.0% in Group B (P = 0.058). Febrile morbidity was 1.2% and 2.3%, respectively (P = 0.509). Urinary tract infection occurred in one patient in Group A (P = 0.494). CONCLUSIONS: Single-dose AMP for CS is as effective as multiple doses in preventing SSI. This trial was registered in the Pan African Clinical Trial Registry (www.pactr.org) database with unique identification number PACTR202009483150226.