NCT05122169尚未招募不适用
Establishment of Clinical Practice Guideline to Prevent Puerperal / Perinatal Infection in Vaginal Delivery for Pregnant Women and Newborns
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 4,140
- 主要终点
- Number of participant with episiotomy site infection
研究概览
简要总结
This is a multi-center, randomized, controlled trial study to find whether use of chlorhexidine-alcohol or povidone-iodine for pre-vaginal delivery skin prep is superior to reduce postpartum infection in pregnant women with vaginal delivery. The primary outcome is the episiotomy site infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with singleton pregnancy
- •Women who will undergo vaginal delivery after 37+0/7 weeks of gestation
排除标准
- •Women who are allergy to chlorhexidine, alcohol, iodine, or shellfish
- •Women with any infection at perineum (before vaginal delivery)
研究组 & 干预措施
chlorhexidine
Experimental
Pre-vaginal delivery skip prep using chlorhexidine-alcohol
干预措施: Chlorhexidine (Drug)
Povidone-iodine
Active Comparator
Pre-vaginal delivery skip prep using Povidone-iodine
干预措施: Povidone-Iodine (Drug)
结局指标
主要结局
Number of participant with episiotomy site infection
时间窗: 21 days
Superficial or deep infection of episiotomy site
次要结局
未报告次要终点
研究者
Joong Shin Park
Professor
Seoul National University Hospital
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