A RCT comparing the effectiveness of a single dose of antimicrobial prophylaxis versus multiple doses during emergency caesarean section in Rwanda

Abstract

Background: Cesarean section is one the most common surgeries done worldwide and surgical site infection (SSI) is one of the main complications resulting in major morbidity ad mortality post cesarean. Prophylactic antibiotics are the main intervention to prevent post-cesarean SSI. However misuse of antibiotics is a very common practice especially in environments where other factors may increase the risk of postoperative infection. Objectives: To determine whether a single dose of antimicrobial prophylaxis is as effective as multiple doses in prevention of post emergency cesarean section SSI in low resource maternity settings. Methods: A randomized clinical trial of single dose Ampicillin vs multiple doses in the setting of emergency cesarean was conducted in a large rural hospital in Rwanda (Ruhengeri Hospital) where approxiamtelly1800 Cesarean deliveries are performed annually. All patients undergoing emergency cesarean section were assessed for eligibility for inclusion in the study and written informed consent was obtained. Participants were randomized into two different study arms with aid of computer generated sets of random allocation through block randomizations; the first study arm was composed of women receiving one dose of 2 g Ampicillin 15 to 60 minutes prior to skin incision and the second arm (B) was composed of women receiving 2 g prior to skin incision then extended dosing of 1g Ampicillin every 8 hours over 72 hours. Participants were followed for 30 days post cesarean section for surgical site infection. Results: Three hundred and one participants were analyzed (154 in the group of multiple dose and 147 on the single dose group ). Demographic and clinical data were collected by chart review and patient phone interviews were performed on Days 3, 7, 15 and 30. There were 8 surgical site infections in Group A and 4 in Group B (p=0.089). The overall prevalence of surgical site infections was lower than expected (4.00%). Enrolment of 550 participants would have been needed to demonstrate a difference between groups considering the low rate of SSI observed in our study. Most of SSIs were diagnosed on day 7 (66.6% of all cases of SSI) and only 22.2% of cases were diagnosed at discharge(day 3). On day 15 only one case was diagnosed and no new cases were diagnosed on day 30. Conclusion: The rate of SSI was low at 4.00% compared to what we estimated from the prior literature. The difference observed with a P value of 0.204 in the two groups was still in the equivalence margins though our study considers the use of single dose of antibiotic as adequate and preferable. However, our findings suggest the need of a larger sample as the majority of SSI were seen in the group of single dose even though the difference in number of cases seen was not significant. Funding: TRiVE (The “Training Health Researchers into Vocational Excellence in East Africa”) and Ministry of Health.