Gastric Emptying After Tea With Milk in Pregnancy.

Coombe Women and Infants University Hospital

Status: Completed

Conditions: Gastric Emptying

Treatments: Other: Breakfast tea with full fat milk; Other: Water

Study type: Interventional

Funder types: Other

Identifiers

NCT03694509

CWIUH-GUS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Breakfast tea with full fat milk

Experimental group

Description:

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.

Treatment:

Other: Breakfast tea with full fat milk

Water

Active Comparator group

Description:

Water 250ml

Treatment:

Other: Water