Eley Victoria A, Navarro Severine, Martin Elizabeth, Amoako Akwasi, Hartel Gunter, Woods Christine, Lu Yan, Lipman Jeffrey, Roberts Jason, Tang Mimi, Callaway Leonie
Department of Anaesthesia and Perioperative Medicine, The Royal Brisbane and Women's Hospital, Butterfield St, Herston, Brisbane, 4006, Queensland, Australia.
Medical School, Faculty of Medicine, The University of Queensland, St Lucia 4067, Brisbane, QLD, Australia.
BMC Pregnancy Childbirth. 2025 Mar 26;25(1):353. doi: 10.1186/s12884-025-07484-5.
Pre-incisional antibiotics are recommended for all patients having cesarean delivery, despite emerging concerns regarding effects on the infant. In this feasibility blinded randomized controlled trial we aimed to test research processes in low-risk women receiving cefazolin or placebo prior to elective cesarean delivery.
The trial was prospectively registered (ACTRN12619001705178). Eligible women were aged ≥ 18 and < 40 years, ≥ 37 weeks gestation, at low risk of surgical site infection (SSI) and recruited from a single tertiary centre. We reported proportions of women eligible and consenting; adherence to perioperative infection prevention; blinding adequacy of staff using Bang's blinding index; SSI surveillance and diagnosis according to the Centre for Disease Control definitions and patient reported outcome measures using validated questionnaires up to 90 days.
We screened 1651 women, with 1245 (75%) ineligible based on body mass index or presence of diabetes. Of 287 eligible women, 30 were randomized (11%) with 15 in each group. Reasons for non-participation included "wanting antibiotics" (68, 27%), "no reason" (62, 25%) and lack of research staff (33, 13%). Compliance with perioperative infection prevention occurred in 5 of 7 steps. Spontaneous placental separation occurred in 25 (83%) and Comfeel dressing in 29 (97%). Blinding was adequate for all staff groups. SSI surveillance occurred in 156 of 210 (74%) timepoints. SSI occurred in two patients who received pre-incisional cefazolin and were successfully treated as outpatients. Patient reported outcome questionnaires were completed at 136 of 180 (76%) timepoints. There was no difference in maternal health-related quality of life between the groups.
Feasibility was impacted by the high-risk population and patient desire for antibiotics. Adherence to perioperative infection prevention practices were high but incomplete. These study processes could be effectively applied in a larger population, targeting low risk maternity patients.
Prospectively registered 4/12/2019 with the Australian New Zealand Clinical Trials Registry (ACTRN12619001705178).
尽管对婴儿的影响存在新的担忧，但对于所有行剖宫产的患者，均建议在切开前使用抗生素。在这项可行性双盲随机对照试验中，我们旨在测试在择期剖宫产术前接受头孢唑林或安慰剂的低风险女性的研究过程。
该试验已进行前瞻性注册（澳大利亚和新西兰临床试验注册号：ACTRN12619001705178）。符合条件的女性年龄≥18岁且<40岁，妊娠≥37周，手术部位感染（SSI）风险低，且从单一的三级中心招募。我们报告了符合条件并同意参与的女性比例；围手术期感染预防措施的依从性；使用邦氏盲法指数评估工作人员的盲法充分性；根据疾病控制中心的定义进行SSI监测和诊断，以及使用经过验证的问卷对患者进行长达90天的报告结局测量。
我们筛查了1651名女性，其中1245名（75%）因体重指数或患有糖尿病而不符合条件。在287名符合条件的女性中，30名（11%）被随机分组，每组15名。未参与的原因包括“想要使用抗生素”（68名，27%）、“无理由”（62名，25%）和缺乏研究人员（33名，13%）。围手术期感染预防的7个步骤中有5个得到了遵守。25名（83%）出现了自然胎盘剥离，29名（97%）使用了康惠尔敷料。所有工作人员组的盲法均充分。210个时间点中的156个（74%）进行了SSI监测。两名接受切开前头孢唑林治疗的患者发生了SSI，并作为门诊患者成功治疗。患者报告结局问卷在180个时间点中的136个（76%）完成。两组之间产妇与健康相关的生活质量没有差异。
可行性受到高风险人群和患者对抗生素的需求的影响。围手术期感染预防措施的依从性很高，但并不完全。这些研究过程可以有效地应用于更大规模的人群，以低风险产妇为目标。
于2019年12月4日在澳大利亚和新西兰临床试验注册中心进行前瞻性注册（ACTRN12619001705178）。
