Gastric Emptying After Tea With Milk in Pregnancy.

赞助:

合作者:

信息的提供 (责任方):

Ruairi Irwin，Coombe Women and Infants University Hospital

追踪信息

首次提交日期 ^ICMJE

October 1, 2018

首次发布日期e ^ICMJE

October 3, 2018

最后更新发布日期

October 4, 2018

预计研究开始日期 ^ICMJE

October 3, 2018

预计主要完成日期

February 1, 2019 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Gastric emptying at 2 hours - supine.[ Time Frame: 120 mins ]

The difference in gastric antrum cross sectional area (CSA) between groups, measured using ultrasound in a 45° semirecumbent supine position.

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Gastric antrum CSA - supine.[ Time Frame: 15 mins, 30 mins, 45 mins, 60 mins, 90 mins ]
The difference in gastric antrum cross sectional area (CSA) between groups, measured using ultrasound in a 45° semirecumbent supine position.
Gastric volume - supine.[ Time Frame: 15 mins, 30 mins, 45 mins, 60 mins, 90 mins, 120 mins ]
The difference in gastric volume as calculated using the determined CSA in the 45° semirecumbent supine position.
Gastric antrum CSA - RLD.[ Time Frame: 15 mins, 30 mins, 45 mins, 60 mins, 90 mins, 120 mins ]
The difference in gastric antrum cross sectional area (CSA) between groups, measured using ultrasound in the 45° semirecumbent RLD (Right lateral decubitus) position.
Gastric volume - RLD.[ Time Frame: 15 mins, 30 mins, 45 mins, 60 mins, 90 mins, 120 mins ]
The difference in gastric volume as calculated using the determined CSA in the 45° semirecumbent RLD position.

描述性信息

简略标题 ^ICMJE

Gastric Emptying After Tea With Milk in Pregnancy.

正式标题 ^ICMJE

Gastric Emptying of Tea With Milk in Pregnancy - An Ultrasound Assessment.

简要概况

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.

详细说明

The study involves the allocation of either 300ml of water or 250ml 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 250ml 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: The placebo group will be given 300ml of water. 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.

研究类型 ^ICMJE

Interventional

研究阶段

N/A

研究设计 ^ICMJE

分配: Randomized
干预模型: Parallel Assignment
干预模型描述: Two groups - Tea with milk group and water control group.
盲法: Interventional
盲法描述:The ultrasound assessor will be blinded to group allocation. The statistician will be blinded to group allocation.
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Other: Breakfast tea with full fat milk
Assessment of gastric emptying using ultrasound. 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.
Other: Water
Water 250ml.

研究工具

Experimental: 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.
Active Comparator: Water
Water 250ml

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

February 1, 2019

预计主要完成日期

February 1, 2019 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - 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. Exclusion Criteria: - 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.

性别

参与研究的性别:

Female

年龄

最小年龄：18 Years ，最大年龄：N/A

接受健康的志愿者

没有

可入组国家 ^ICMJE

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

Ruairi Irwin，Coombe Women and Infants University Hospital

研究赞助商 ^ICMJE

Coombe Women and Infants University Hospital

合作者 ^ICMJE

研究员 ^ICMJE

Study Director: Terry Tan Head of Department of Anaesthesia CWIUH

PRS 账户

Coombe Women and Infants University Hospital

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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