Clinical trial NCT03694509: Gastric Emptying After Tea With Milk in Pregnancy.
Official title: Gastric Emptying of Tea With Milk in Pregnancy - An Ultrasound Assessment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Emptying
Keywords: Gastric emptying
tea
milk
pregnancy
gastric ultrasound
ultrasound
gastric antrum
Lead sponsor: Coombe Women and Infants University Hospital
Sponsor class: OTHER
First posted: 2018-10-03
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups - Tea with milk group and water control group.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Gastric emptying at 2 hours - supine.
timeFrame: 120 mins
Secondary outcomes:
measure: Gastric antrum CSA - supine.
timeFrame: 15 mins, 30 mins, 45 mins, 60 mins, 90 mins
measure: Gastric volume - supine.
timeFrame: 15 mins, 30 mins, 45 mins, 60 mins, 90 mins, 120 mins
measure: Gastric antrum CSA - RLD.
timeFrame: 15 mins, 30 mins, 45 mins, 60 mins, 90 mins, 120 mins
measure: Gastric volume - RLD.
timeFrame: 15 mins, 30 mins, 45 mins, 60 mins, 90 mins, 120 mins
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Coombe Women and Infants University Hospital
Study officials:
affiliation: Head of Department of Anaesthesia CWIUH
name: Terry Tan
role: STUDY_DIRECTOR
References:
citation: 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.