Gastric Emptying of Tea With Milk in Pregnancy - An Ultrasound Assessment.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Gastric emptying at 2 hours - supine.
研究概览
简要总结
The aim of the study is to assess the difference in gastric emptying using ultrasound of pregnant patients following a cup of tea with milk or a similar volume of water.
详细描述
The study involves the allocation of either 250ml of water or 200ml of tea and 50ml of milk to fasted parturients, and assessment of gastric antrum CSA at intervals up to 2 hours. The study will be performed in patients with >34 weeks gestation at the antenatal clinic. The participants will be randomized into one of two groups with an internet based randomisation tool, and then allocated to either group as per the allocation in a sealed opaque envelope. The ultrasound assessor will be blinded to the group allocation.
Participants will be asked to come to clinic in the morning fasting from solids for >6 hours and for 2 hours for clear fluids. Gastric ultrasound will be performed on the fasted pregnant patients in the right lateral decubitus position to establish a baseline and ensure that the gastric antrum is empty. Gastric antrum CSA will be measured.
Intervention group:
The intervention group will be given 200ml of black breakfast tea with 50ml of full fat milk. This should be consumed within 5 minutes. Gastric ultrasound will be performed at intervals up to 2 hours after the intervention in the right lateral decubitus position. Gastric antrum CSA will be measured. Three measurements of CSA will be taken and averaged.
Placebo group:
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The ultrasound assessor will be blinded to group allocation. The statistician will be blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with a singleton pregnancy >36 weeks.
- •Subjects must be female, aged 18 years or above at baseline.
- •Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol.
排除标准
- •Allergy/sensitivity to milk/tea.
- •A medical or surgical condition leading to delayed gastric emptying (e.g. Diabetes Mellitus).
- •Not fasting for 6 hours for food or 2 hours for clear fluids.
- •No baseline ultrasound assessment.
- •Inability to visualize the gastric antrum.
- •Vomiting or inability to finish drink.
研究组 & 干预措施
Breakfast tea with full fat milk
Black breakfast tea (200ml) with full fat milk (50ml) - The volume of milk added to the tea is at the discretion of the patient but the remaining milk must be consumed afterwards.
干预措施: Breakfast tea with full fat milk (Other)
Water
Water 250ml
干预措施: Water (Other)
结局指标
主要结局
Gastric emptying at 2 hours - supine.
时间窗: 120 mins
The difference in gastric antrum cross sectional area (CSA) between groups, measured using ultrasound in a 45° semirecumbent supine position.
次要结局
- Gastric antrum CSA - supine.(15 mins, 30 mins, 45 mins, 60 mins, 90 mins)
- Gastric antrum CSA - RLD.(15 mins, 30 mins, 45 mins, 60 mins, 90 mins, 120 mins)
- Gastric volume - RLD.(15 mins, 30 mins, 45 mins, 60 mins, 90 mins, 120 mins)
- Gastric volume - supine.(15 mins, 30 mins, 45 mins, 60 mins, 90 mins, 120 mins)
研究者
Ruairi Irwin
Principal investigator
Coombe Women and Infants University Hospital