单次剂量庆大霉素联合甲硝唑与多次剂量预防剖宫产术后感染的疗效比较：一项随机对照试验研究方案。
Efficacy of single dose of gentamicin in combination with metronidazole versus multiple doses for prevention of post-caesarean infection: study protocol for a randomized controlled trial.
机构信息
Department of Obstetrics and Gynaecology, Catholic University of Health Sciences and Allied Science and Bugando Medical Centre, Box 1464, Mwanza, Tanzania.
出版信息
Trials. 2012 Jun 21;13:89. doi: 10.1186/1745-6215-13-89.
BACKGROUND
Caesarean section is a commonly performed operation worldwide. It has been found to increase rates of maternal infectious morbidities more than five times when compared to vaginal delivery. Provision of intravenous prophylactic antibiotics 30 to 60 minutes prior to caesarean section has been found to reduce post-caesarean infection tremendously. Many centers recommend provision of a single dose of antibiotics, as repeated doses offer no benefit over a single dose. At Bugando Medical Centre post caesarean infection is among the top five causes of admission at the post-natal ward. Unfortunately, there is no consistent protocol for the administration of antibiotic prophylaxis to patients who are designated for caesarean section. Common practice and generally the clinician's preference are to provide repeated dosages of antibiotic prophylaxis after caesarean section to most of the patients. This study aims 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/DESIGN: The study is an interventional, open-label, two-armed, randomized, single-center study conducted at Bugando Medical Centre Mwanza, Tanzania. It is an ongoing trial for the period of seven months; 490 eligible candidates will be enrolled in the study. Study subjects will be randomly allocated into two study arms; "A" and "B". Candidates in "A" will receive a single dose of gentamicin in combination with metronidazole 30 to 60 minutes prior to the operation and candidates in "B" will receive the same drugs prior to the operation and continue with gentamicin and metronidazole for 24 hours. The two groups will be followed up for a period of one month and assessed for signs and symptoms of surgical site infection. Data will be extracted from a case record form and entered into Epi data3.1 software before being transferred to SPSS version 17.0 for analysis. The absolute difference in proportion of women who develop surgical site infection in the two study arms will be the effectiveness of one regime over the other.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN44462542.
背景
剖宫产术是一种在全球范围内广泛施行的手术。与阴道分娩相比，剖宫产术会使产妇感染性发病率增加五倍以上。在剖宫产术前 30 至 60 分钟内给予静脉预防性抗生素已被证明可极大地降低剖宫产术后感染率。许多中心建议给予单次剂量的抗生素，因为多次剂量与单次剂量相比没有益处。在布根达医疗中心，剖宫产术后感染是产后病房住院的前五大原因之一。不幸的是，对于计划行剖宫产术的患者，没有一致的抗生素预防给药方案。常见的做法是，大多数患者在剖宫产术后给予重复剂量的抗生素预防。本研究旨在比较单次剂量的庆大霉素联合甲硝唑与多次剂量预防剖宫产术后感染的疗效。
方法/设计：该研究是在坦桑尼亚姆万扎布根达医疗中心进行的一项干预性、开放性标签、双臂、随机、单中心研究。这是一项为期七个月的正在进行的试验；将有 490 名符合条件的候选者纳入研究。研究对象将随机分为两组；“A”组和“B”组。“A”组的候选者将在手术前 30 至 60 分钟内接受单次剂量的庆大霉素联合甲硝唑，而“B”组的候选者将在手术前接受相同的药物，并继续使用庆大霉素和甲硝唑 24 小时。两组将随访一个月，评估手术部位感染的症状和体征。数据将从病历表中提取并输入 Epi data3.1 软件，然后转移到 SPSS 版本 17.0 进行分析。两组中发生手术部位感染的女性比例的绝对差异将是一种方案优于另一种方案的效果。
试验注册
当前对照试验 ISRCTN44462542。
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