دورية أكاديمية

Single dose of gentamicin in combination with metronidazole versus multiple doses for prevention of post-caesarean infection at Bugando Medical Centre in Mwanza, Tanzania: a randomized, equivalence, controlled trial

التفاصيل البيبلوغرافية
العنوان: Single dose of gentamicin in combination with metronidazole versus multiple doses for prevention of post-caesarean infection at Bugando Medical Centre in Mwanza, Tanzania: a randomized, equivalence, controlled trial
المؤلفون: Lyimo, Fadhili M, Massinde, Anthony N, Kidenya, Benson R, Konje, Eveline T, Mshana, Stephen E
بيانات النشر: BioMed Central Ltd.
سنة النشر: 2013
المجموعة: BioMed Central
مصطلحات موضوعية: Post-caesarean infection, Metronidazole, Gentamicin, Mwanza, Tanzania
الوصف: Background Caesarean section(C/S) has been found to increase rates of maternal infectious morbidities five times more than vaginal delivery. The provision of intravenous prophylactic antibiotics 30 to 60 minutes prior to C/S has been found to substantially reduce post-caesarean infection. At Bugando Medical Centre, there is no consistent protocol for the administration of antibiotic prophylaxis to patients who are undergoing emergency C/S. Providing repeated dosages of antibiotic prophylaxis after C/S is the common practice. This study aimed to determine the comparative efficacy of a single dose of gentamicin in combination with metronidazole versus multiple doses for prevention of post-caesarean infection. Methods From October 2011 to May 2012, a randomized, equivalence, non-blinding clinical trial was conducted at Bugando Medical Centre in Mwanza, Tanzania. A total of 500 eligible participants were enrolled in the study and were randomly allocated into two study arms -- “A” and “B”. Participants in “A” received a single dose of gentamicin in combination with metronidazole 30 to 60 minutes prior to the operation, and participants in “B” received the same drugs prior to the operation but continued with for 24 hours. Both groups had 30 days of follow-up and were assessed for signs and symptoms of surgical-site infection as the primary outcome. The equivalence margin was set at 5%. The two-tailed equivalence was analyzed based on intention- to-treat analysis. Results The randomization was proper, as the distribution of various demographic and other baseline characteristics had a p-value of > 0.05. All 500 participants were included in our analysis; of these, no participants were lost to follow-up. Surgical-site infection occurred in 12 out of the 250 (4.8%) receiving single dose compared to 16 out of the 250 (6.4%) receiving multiple doses. There is an absolute proportion difference of 1.6% (95% Confidence interval: -2.4 – 5.6%) which lies outside the pre-specified 5% equivalence margin. Conclusion We ...
نوع الوثيقة: article in journal/newspaper
اللغة: English
العلاقة: http://www.biomedcentral.com/1471-2393/13/123Test
الإتاحة: http://www.biomedcentral.com/1471-2393/13/123Test
حقوق: Copyright 2013 Lyimo et al.; licensee BioMed Central Ltd.
رقم الانضمام: edsbas.F8E3B48D
قاعدة البيانات: BASE