Gastric Emptying After Tea With Milk in Pregnancy.

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

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.

Study Overview

• Status: Completed
• Conditions: Gastric Emptying
• Intervention / Treatment: Other: Breakfast tea with full fat milk; Other: Water

Detailed Description

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:

The placebo group will be given 250ml 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland, 00000
    • Coombe Women and Infants University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
Active Comparator: Water; Water 250ml	Other: Water; Water 250ml.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric emptying at 2 hours - supine.	The difference in gastric antrum cross sectional area (CSA) between groups, measured using ultrasound in a 45° semirecumbent supine position.	120 mins

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Coombe Women and Infants University Hospital
• Investigators: Study Director: Terry Tan, Head of Department of Anaesthesia CWIUH

Publications and helpful links

General Publications

• Irwin R, Gyawali I, Kennedy B, Garry N, Milne S, Tan T. An ultrasound assessment of gastric emptying following tea with milk in pregnancy: A randomised controlled trial. Eur J Anaesthesiol. 2020 Apr;37(4):303-308. doi: 10.1097/EJA.0000000000001129.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2018
• Primary Completion (Actual): June 27, 2019
• Study Completion (Actual): June 27, 2019

Study Registration Dates

• First Submitted: October 1, 2018
• First Submitted That Met QC Criteria: October 1, 2018
• First Posted (Actual): October 3, 2018

Study Record Updates

• Last Update Posted (Actual): August 16, 2019
• Last Update Submitted That Met QC Criteria: August 15, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: ultrasound; pregnancy; Gastric emptying; milk; tea; gastric ultrasound; gastric antrum
• Other Study ID Numbers: CWIUH-GUS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No