NCT00367549已完成不适用
Nutrition as Determinant of Labor Outcome
Oslo University Hospital2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2006年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- The course of the labor by women (parity 0) at gestational age > 36 weeks, including: total labor time
研究概览
简要总结
This is a randomized, double-blind trial looking at how nutrition intake is associated with labor progress and complications.
详细描述
Insufficient intake of energy during labor may result in poor labor progress. The study investigates the effect of an energy supplement during labor.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women at gestational age > 36 weeks, parity 0
排除标准
- •Gestational age < 36 weeks
- •Signs of fetal pathology:
- •Different or abnormal (pathological) CTG test performed just before start of the test
- •Abnormal Doppler registrations (PI in the arteria umbilicae > 2SD for the gestational age)
- •Established notch in the arteria uterinae or notch bilaterally or PI > 2SD > 24 weeks
- •Diverging in the weight of the fetus > - 22% or diverging in the growth of the fetus - 10% or more, and established structural pathology in the fetus, oligohydramnion (amniotic fluid index < 6)
- •Maternal diseases and pregnancy complications
- •diabetes in pregnancy
- •high blood pressure
- •cardiovascular diseases
- •rheumatic disease
- •epilepsia
- •lung disease, etc.
- •CTG test: cardiotocographic test (a measure of fetal activity)
- •PI: pulsatory index (velocity pattern)
- •SD: standard deviation
结局指标
主要结局
The course of the labor by women (parity 0) at gestational age > 36 weeks, including: total labor time
时间窗: At time of birth
次要结局
- Length of stage 1 (cervical opening < 10 cm) and stage 2 (pushing time)
- Use of epidural anesthetics
- Use of contraction-stimulating drugs
- Instrumental delivery
研究者
研究点 (2)
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