Fluid Intake During Labour, Ultrasound Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 156
- 试验地点
- 6
- 主要终点
- Percentage of parturients with a full stomach
研究概览
简要总结
We designed a two arms prospective, randomised, simple blinded trial to compare the impact of clear liquid intake on gastric content before delivery. We hypothesize that there will be no difference between the two groups, leading to safety of clear liquid intake during labour.
详细描述
Gastric emptying is a major concern for anesthetists in obstetric. In order to prevent the risk of gastric aspiration, we are used to forbid to eat and to drink during labour.
However, this behaviour is controversial and some studies have shown that clear liquid intake can be safe during labour. Informations from a bedside ultrasound examination of the stomach content may be a useful tool to balance benefits and risks of such attitude. This technique has recently been shown very promising in pregnant women for the assessment of the gastric volume.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Any pregnant woman at term
排除标准
- •Pathologic pregnancy
- •Twin pregnancy
- •Body mass index above 35 kg/m2 before pregnancy
- •Cervix dilation above 8 cm
研究组 & 干预措施
Apple juice
Patient are allowed to drink up to 400 ml of apple juice
干预措施: Apple juice (Other)
Control
Patient are not allowed to drink
结局指标
主要结局
Percentage of parturients with a full stomach
时间窗: average of 6 hours
A full stomach is defined by an antral area above 300 mm2 evaluated by ultrasound imaging
次要结局
- Evolution of the antral area(average of 6 hours)
- Pain intensity(average of 6 hours)
- Parturient comfort(average of 6 hours)
- Anxiety(average of 6 hours)