Gastric Emptying of Maltodextrin Compared to Coffee With Milk and Orange Juice During Labor at Term: Non-inferiority Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Change from Baseline Gastric antral area
研究概览
简要总结
This study evaluates the gastric emptying of pregnant woman at term who received one of the three solutions: maltodextrin, orange juice or coffee with milk.
详细描述
Allocation in maltodextrin, orange juice or coffee with milk will be random using sealed envelopes. Gastric ultrasound will be used for estimating gastric volume by measuring antral area in right lateral decubiti. All solutions will have the same volume and total of calories.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Investigator and outcomes assessor will not know to which group each woman was allocated
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnancy at term
- •Fasted with an emptying stomach (assessed by ultrasound)
- •During Labor
- •No diabetes, esophageal disease, obesity
- •Not emergency
- •High risk of need of general anesthesia
排除标准
- •Vomiting before the end of the protocol
- •Did not drink the whole solutions
- •Ultrasound not performed for any reason
研究组 & 干预措施
Orange Juice
Fasted pregnant woman with an empty stomach (assessed by ultrasound) will drink 500ml of orange juice, 200kcal, 2,82g of protein, 0,67g of fat, 47,08g of carbohydrate.
干预措施: Orange Juice (Dietary Supplement)
Coffee with milk
Fasted pregnant woman with an empty stomach (assessed by ultrasound) will drink 500ml of coffee with milk, 200kcal, 10,6g of protein, 10,73g of fat, 14,9g of carbohydrate.
干预措施: Coffee with milk (Dietary Supplement)
Maltodextrin
Fasted pregnant woman with an empty stomach (assessed by ultrasound) will drink 500ml of maltodextrin 200kcal, no protein or fat, 49,5g of carbohydrate.
干预措施: Maltodextrin (Dietary Supplement)
结局指标
主要结局
Change from Baseline Gastric antral area
时间窗: baseline (before drinking allocated solution), 30, 60, 90 and 120 minutes after drinking.
Change from Baseline Gastric antral area measured by ultrasound
次要结局
未报告次要终点
研究者
Gabriel Magalhaes Nunes Guimaraes
Head of anesthesiology
Brasilia University Hospital