在怀孕期间进行B组链球菌的常规检测:英国集群随机试验 (GBS3) 的协议.
Jane Daniels1, Kate Walker2, Lucy Bradshaw1
1Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.
BMJ open
|June 17, 2025
概括
与基于风险的策略相比,在孕妇中进行常规的B型 estreptococcus (GBS) 检测可能会减少早期发作的新生儿败血症. 这项大型集群随机试验将比较不同GBS查方法的有效性和成本效益.
科学领域:
- 产科和妇科 产科和妇科
- 新生儿医学 新生儿医学
- 传染性疾病 传染性疾病
背景情况:
- 乙组链球菌 (GBS) 是早期新生儿败血症的主要原因.
- 目前在怀孕期间对GBS查的策略各不相同,其益处尚不清楚.
- 需要进行比较有效性研究,以确定最佳的GBS查方案.
研究的目的:
- 为了比较常规GBS测试与基于风险因素的策略在减少新生儿早发性败血症方面的有效性.
- 评估产前丰富培养基测试与GBS产后快速测试的成本效益.
- 评估不同GBS查策略在产科单位的实施和可接受性.
主要方法:
- 一个大规模的集群随机试验,涉及80个产科单位多达32万名妇女.
- 随机选择的站点进行常规GBS测试或基于风险因素的策略.
- 常规测试地点进一步随机化为产前或产后测试,并进行产后抗生素预防,以检测阳性GBS或已识别的风险因素.
主要成果:
- 主要结局是全因早期新生儿败血症 (<7天),通过培养,死亡或临床症状和抗生素治疗来定义.
- 成本效益将以每例避免的败血症病例和每次质量调整的生命年增加成本来分析.
- 数据将从常规收集的NHS数据库中收集,并补充过程结果.
结论:
- 该试验旨在提供关于GBS查预防新生儿败血症的最有效和最具成本效益的策略的证据.
- 调查结果将为临床实践指南和医疗保健政策提供有关怀孕期间GBS管理的信息.
- 该研究还将为医疗技术评估提供有价值的经济,质量和实施数据.
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