ISRCTN11166984已完成未知
ANODE: A randomised controlled trial of prophylactic Antibiotics to investigate the prevention of infection following Operative vaginal Delivery
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 3,427
研究概览
简要总结
- 2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/30041702 2. 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31097213 (added 20/05/2019) 3. 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31590702 (added 10/10/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Female aged 16 years or over
- •2. Mental capacity (ability to give informed consent)
- •3. Have had an operative vaginal delivery at at least 36 weeks gestation
排除标准
- •Current exclusion criteria as of 04/05/2018:
- •1. Clinical indication for ongoing antibiotic administration post-delivery e.g. due to confirmed antenatal infection, 3rd or 4th degree tears. Note that receiving antenatal antibiotics e.g. for maternal Group B Streptococcal carriage or prolonged rupture of membranes, is not a reason for exclusion if there is no indication for ongoing antibiotic prescription post-delivery.
- •2. Known allergy to penicillin or to any of the components of co-amoxiclav, as documented in hospital notes.
- •3. History of anaphylaxis (a severe hypersensitivity reaction) to another ß-lactam agent (e.g. cephalosporin, carbapenem or monobactam), as documented in hospital notes.
- •Previous exclusion criteria:
- •1. Clinical indication for ongoing antibiotic administration post-delivery (e.g. due to confirmed antenatal infection, third or fourth degree tears)
- •2. Known allergy to penicillin (as documented in hospital notes)
研究者
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