Effect of Oral Carbohydrate Intake > 44kCal Per Hour During Labour on the Rate of Instrumental Vaginal Delivery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- instrumental vaginal delivery
研究概览
简要总结
Carbohydrate intake during physical exercise improves muscle performance and decreases fatigue. We hypothesized that carbohydrate intake during labor which is a period of significant physical activity can decrease the instrumental vaginal delivery rate.
In a previous study we reported a trend toward a decrease in instrumental vaginal delivery and the mount of carbohydrate intake during labour. However due to some limitations no clear conclusion could be drawn.
The present study is designed to examine the relationship between a high calory oral intake (>44 kCal/hour during labour) and the rate of instrumental delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcome assessor (i.e. obstetrician) will be unaware of group allocation
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •nulliparous women
- •singleton pregnancy
- •social insurance
- •uncomplicated pregnancy
- •no contraindication to vaginal delivery
排除标准
- •scheduled caesarean section
- •labor < 37 weeks of gestational age
- •cervical dilation > 8cm at inclusion
- •scheduled induced delivery
- •contraindication to pushing effort during labor and delivery
- •BMI > 40 kg/m2
- •medical history of diabetes mellitus, hypertension, heart disease
结局指标
主要结局
instrumental vaginal delivery
时间窗: 2 days
rate of instrumental vaginal delivery
次要结局
- oxytocin administration(2 days)
- caesarean section(2 days)
- nausea and vomiting(2 days)
- thirst sensation on verbal rating scale(2 days)
- hunger sensation on verbal rating scale(2 days)
- fatigue(2 days)
- umbilical blood pH(1 min)
- oxytocin administration(2 days)
- caesarean section(2 days)
- nausea and vomiting(2 days)
- thirst sensation on verbal rating scale(2 days)
- hunger sensation on verbal rating scale(2 days)
- fatigue(2 days)
- umbilical blood pH(1 min)