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 17th September 2015 up to 29th 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, 7th April, 2016.
Highlights
The single most important risk factor for postpartum maternal infection is caesarean section
This study was a randomized clinical trial in which single dose therapy of ceftriaxone and metronidazole was compared to multiple doses in women who were undergoing elective caesarean section on the incidence of postoperative wound infection
The total infectious morbidity and endometritis was found to be lower in the preoperative antibiotic group there was no difference in the wound infection
Summary
Author roles: Mugisa GA: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Project Administration, Resources, Writing – Original Draft Preparation, Writing – Review & Editing; Kiondo P: Conceptualization, Methodology, Supervision, Writing – Review & Editing; Namagembe I: Conceptualization, Methodology, Supervision, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing. How to cite this article: Mugisa GA, Kiondo P and Namagembe I. Grant information: Wide Spectrum Enterprise Uganda who provided the ceftriaxone for the study, and trainee Imelda Namagembe who supervised Mugisa Gideon during the writing, and conduct of this research up working on the manuscript is supported buy DELTAS Africa Initiative THRiVE-2 [DEL-15-011]. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript
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