Gastric Emptying After Tea With Milk in Pregnancy.

NCT03694509 | Completed

• 1 other identifier: CWIUH-GUS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Emptying

Keywords

Gastric emptying; tea; milk; pregnancy; gastric ultrasound; ultrasound; gastric antrum

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Gastric antrum CSA - supine.

  15 mins, 30 mins, 45 mins, 60 mins, 90 mins

• Gastric volume - supine.

  15 mins, 30 mins, 45 mins, 60 mins, 90 mins, 120 mins

• Gastric antrum CSA - RLD.

  15 mins, 30 mins, 45 mins, 60 mins, 90 mins, 120 mins

• Gastric volume - RLD.

  15 mins, 30 mins, 45 mins, 60 mins, 90 mins, 120 mins

Study Arms (2)

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.

Other: Breakfast tea with full fat milk

Water

ACTIVE COMPARATOR

Water 250ml

Other: Water

Interventions

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.

Breakfast tea with full fat milk

Water OTHER

Water 250ml.

Water

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Coombe Women and Infants University Hospital: lead

Study Sites (1)

Coombe Women and Infants University Hospital

Dublin, 00000, Ireland

Location

Related Publications (1)

• 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.

  PMID: 31789899 DERIVED

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Terry Tan

  Head of Department of Anaesthesia CWIUH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The ultrasound assessor will be blinded to group allocation. The statistician will be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Two groups - Tea with milk group and water control group.

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: October 3, 2018
• Study Start: October 30, 2018
• Primary Completion: June 27, 2019
• Study Completion: June 27, 2019
• Last Updated: August 16, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)