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Gastric Emptying of Tea With Milk in Pregnancy - An Ultrasound Assessment.
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.
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.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Coombe Women and Infants University Hospital
Dublin, Ireland
Start Date
October 30, 2018
Primary Completion Date
June 27, 2019
Completion Date
June 27, 2019
Last Updated
August 16, 2019
50
ACTUAL participants
Breakfast tea with full fat milk
OTHER
Water
OTHER
Lead Sponsor
Coombe Women and Infants University Hospital
NCT04229043
NCT02665923
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05709197