Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
50 participants
INTERVENTIONAL
2018-10-30
2019-06-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of the Effect of Body Mass Index on Gastric Volume With Ultrasound in Term Pregnant Women
NCT03555604
Ultrasound Assessment of Gastric Volume in High-Risk Pregnant Women At Term
NCT06803225
Ultrasound Assessment of Gastric Emptying
NCT01672424
Early Pregnancy Ultrasound Measurements and Prediction of First Trimester Pregnancy Loss.
NCT06540092
Assessing Gestational Age in First Trimester Pregnancies Using Ultrasound
NCT03957200
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Breakfast tea with full fat milk
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
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
Water
Water 250ml.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Coombe Women and Infants University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ruairi Irwin
Principal investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Terry Tan
Role: STUDY_DIRECTOR
Head of Department of Anaesthesia CWIUH
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Coombe Women and Infants University Hospital
Dublin, , Ireland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CWIUH-GUS
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.