Neonatal Outcomes in Instrumental Delivery: Newborn Head Mark and Comfort.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Head mark or injury
研究概览
简要总结
The aim of this study is to compare the impact of instrumental delivery on newborn head mark and newborn comfort over the impact of non-instrumental delivery. It is also to evaluate how mothers age, Body Mass Index, instrumental extraction indication, extractor type, variety and height of the fetal presentation, operator, time of birth (day or night) and birth weight impact on head mark existence and newborn comfort.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Hours 至 72 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •term infant
- •non-opposition of the newborn parent
排除标准
- •outborn child
- •premature newborn
- •newborn transferred
结局指标
主要结局
Head mark or injury
时间窗: 12 to 72 hours of age
Any mark or injury (skin erosion, wound, hematoma, fracture, paralysis, etc.) on the newborn head will be described (type, color, size, position) and documented (photo)
Newborn comfort
时间窗: 12 to 72 hours of age
assessed using Newborn Pain and Discomfort Scale (EDIN) (DEBILLON et al. Development and initial validation of the EDIN scale, a new tool for assessing prolonged pain in preterm infants. Arch Dis Child Neonatal Ed 2001;85:36-41)
次要结局
- Analgesic use(0 to 72 hours of age)
- Length of hospitalisation after childbirth(First month of life)