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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breakfast tea with full fat milk | Experimental | 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. |
|
| Water | Active Comparator | Water 250ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breakfast tea with full fat milk | Other | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Terry Tan | Head of Department of Anaesthesia CWIUH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coombe Women and Infants University Hospital | Dublin | 00000 | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31789899 | Derived | 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. |
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| ID | Term |
|---|---|
| D014867 | Water |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 |
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Two groups - Tea with milk group and water control group.
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The ultrasound assessor will be blinded to group allocation. The statistician will be blinded to group allocation.
| Water | Other | Water 250ml. |
|
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 |
| Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |