Gastric Emptying After Tea With Milk in Pregnancy.

Gastric Emptying Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03694509
• Other study ID #: CWIUH-GUS
• Status: Completed
• Phase: N/A
• Start date: October 30, 2018
• Est. completion date: June 27, 2019

Study information

• Verified date: August 2019
• Source: Coombe Women and Infants University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 27, 2019
• Est. primary completion date: June 27, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Emptying

Intervention

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.
• Water
Water 250ml.

Locations

Country	Name	City	State
Ireland	Coombe Women and Infants University Hospital	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
Coombe Women and Infants University Hospital

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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