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Completed

NCT Number: NCT03694509

Gastric Emptying After Tea With Milk in Pregnancy.

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.

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Key information

Conditions

Gastric Emptying

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Coombe Women and Infants University Hospital

Dublin, 00000, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Water

Other

Water 250ml.

Primary outcomes

  1. Gastric emptying at 2 hours - supine.

    Time frame: 120 mins

    The difference in gastric antrum cross sectional area (CSA) between groups, measured using ultrasound in a 45° semirecumbent supine position.

Secondary outcomes

  1. Gastric antrum CSA - supine.

    Time frame: 15 mins, 30 mins, 45 mins, 60 mins, 90 mins

    The difference in gastric antrum cross sectional area (CSA) between groups, measured using ultrasound in a 45° semirecumbent supine position.

  2. Gastric volume - supine.

    Time frame: 15 mins, 30 mins, 45 mins, 60 mins, 90 mins, 120 mins

    The difference in gastric volume as calculated using the determined CSA in the 45° semirecumbent supine position.

  3. Gastric antrum CSA - RLD.

    Time frame: 15 mins, 30 mins, 45 mins, 60 mins, 90 mins, 120 mins

    The difference in gastric antrum cross sectional area (CSA) between groups, measured using ultrasound in the 45° semirecumbent RLD (Right lateral decubitus) position.

  4. Gastric volume - RLD.

    Time frame: 15 mins, 30 mins, 45 mins, 60 mins, 90 mins, 120 mins

    The difference in gastric volume as calculated using the determined CSA in the 45° semirecumbent RLD position.

Sponsors and collaborators

Lead sponsor

Coombe Women and Infants University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 3, 2018
Registry last updated
Aug 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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