Single dose ceftriaxone and metronidazole versus multiple doses for antibiotic prophylaxis at elective caesarean section in Mulago hospital: A randomized clinical trial

Abstract

Objective: To compare the incidence of post-operative infections among mothers who received single dose pre-operative ceftriaxone and metronidazole compared to multiple doses after delivery by elective caesarean section. Methods: This was (parallel, balanced randomization, 1:1) open label randomized controlled trial conducted Mulago Hospital, Department of Obstetrics and Gynaecology. Participants included in this study were pregnant women who had been admitted for elective caesarean section. The mothers were randomized to receive single dose of ceftriaxone and metronidazole minutes before the operation or multiple doses 30-60 during the operation and postoperatively. The primary outcome was post-operative wound infection. Secondary outcomes were clinical endometritis and febrile morbidity. The 174 eligible participants were randomized into one of the two treatment arms in a ratio of 1:1. The research assistants who collected the outcomes were blinded to the study allocation. Results: Of the 174 eligible participants who recruited; 87 were randomized to the single dose group while 87 to the multiple doses group. The participants were recruited from 17 th September 2015 up to 29 th February 2016. All the participants were followed up for two weeks after delivery.  Outcome data was available for 79 women in the single dose group and 81 women in the multiple dose group. There were no differences in the incidence of post-operative wound infections between the single dose arm versus the multiple dose arm (RR 1.895; 95% CI (0.2-21.4). There was no clinical endometritis and febrile morbidity observed during the 14 days of follow up. Conclusion: Single dose pre-operative antibiotic prophylactic with ceftriaxone and metronidazole is as effective as multiple doses in prevention of post-operative infectious morbidity in women who undergo elective caesarean section. We recommend the use of single dose ceftriaxone and metronidazole in women undergoing elective caesarean section in our setting. Trial registration: NCT02736682 . Registration date, 7 th April, 2016.