Gastric EmptyingNCT03694509
Gastric Emptying After Tea With Milk in Pregnancy.
A study testing Breakfast tea with full fat milk and Water in people with Gastric Emptying, run by Coombe Women and Infants University Hospital at 1 site in Ireland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gastric Emptying
- What is being tested?
- Breakfast tea with full fat milk and Water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIreland
- Study dates
- 30 Oct 2018to 27 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed 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.
- Conditions
- Gastric Emptying
- Being tested
- Breakfast tea with full fat milk, Water
- Keywords
- Gastric emptying, tea, milk, pregnancy, gastric ultrasound, ultrasound, gastric antrum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breakfast tea with full fat milkOther
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.
WaterOther
Water 250ml.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Breakfast tea with full fat milk |
| Water | Active comparator | Water 250ml Receives: Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 120 mins
Secondary outcomes (4)
Gastric antrum CSA - supine.
The difference in gastric antrum cross sectional area (CSA) between groups, measured using ultrasound in a 45° semirecumbent supine position.
Measured: 15 mins, 30 mins, 45 mins, 60 mins, 90 mins
Gastric volume - supine.
The difference in gastric volume as calculated using the determined CSA in the 45° semirecumbent supine position.
Measured: 15 mins, 30 mins, 45 mins, 60 mins, 90 mins, 120 mins
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.
Measured: 15 mins, 30 mins, 45 mins, 60 mins, 90 mins, 120 mins
Gastric volume - RLD.
The difference in gastric volume as calculated using the determined CSA in the 45° semirecumbent RLD position.
Measured: 15 mins, 30 mins, 45 mins, 60 mins, 90 mins, 120 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start30 Oct 2018
- Primary completion27 Jun 2019
- Study completion27 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric EmptyingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups - Tea with milk group and water control group.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coombe Women and Infants University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruairi Irwin, Coombe Women and Infants University Hospital
- Investigators
- Terry Tan, Study director, Head of Department of Anaesthesia CWIUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03694509
- Sponsor's protocol ID
- CWIUH-GUS
- Status last verified
- Aug 2019
- First submitted
- 1 Oct 2018
- Last updated
- 16 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31789899
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Emptying of Tea With Milk in Pregnancy - An Ultrasound Assessment.
- ClinicalTrials.gov ID
- NCT03694509
- Acronym / sponsor ID
- CWIUH-GUS
- Conditions
- Gastric Emptying
- Keywords
- Gastric emptying, tea, milk, pregnancy, gastric ultrasound, ultrasound, gastric antrum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Coombe Women and Infants University HospitalUniversity, hospital or other
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 27 Jun 2019 (actual)
- Study completion
- 27 Jun 2019 (actual)
- First posted
- 3 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups - Tea with milk group and water control group.
| Arm | Type | Receives |
|---|---|---|
| Breakfast tea with full fat milk | Experimental | Other: Breakfast tea with full fat milkBlack 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 | Active comparator | Other: WaterWater 250ml |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breakfast tea with full fat milkAssessment 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. | Other | Breakfast tea with full fat milk |
| WaterWater 250ml. | Other | Water |
Primary outcome
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.
4 secondary outcomes
Gastric antrum CSA - supine.
Time frame: 15 mins, 30 mins, 45 mins, 60 mins, 90 mins
Gastric volume - supine.
Time frame: 15 mins, 30 mins, 45 mins, 60 mins, 90 mins, 120 mins
Gastric antrum CSA - RLD.
Time frame: 15 mins, 30 mins, 45 mins, 60 mins, 90 mins, 120 mins
Gastric volume - RLD.
Time frame: 15 mins, 30 mins, 45 mins, 60 mins, 90 mins, 120 mins
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2019.
- Derived from this study: PubMed 31789899Irwin 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.
- Individual participant dataSharing planned: No
Related trials for Gastric Emptying
Recruiting
Gastric Focused Ultrasound Stimulation
Gastroparesis, Delayed Gastric Emptying
Not yet recruitingObservational study
Effects of Tirzepatide on Gut Microbiota and Gastrointestinal Function After Drug Withdrawal in Obese Patients
Obesity / Overweight
Not yet recruiting
Stomach-Partitioning Versus Conventional Gastrojejunostomy for Malignant Gastric Outlet Obstruction: A Multicenter Randomized Controlled Trial
Gastric Cancer, Gastric Outlet Obstruction
Not yet recruiting
Gastric Emptying After a Yoghurt Breakfast in Children: a Pilot Study
Preoperative Fasting
Recruiting
Effect of Vagal Nerve Stimulation on Gastric Motor Functions
Depression, Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terry Tan study director
Head of Department of Anaesthesia CWIUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breakfast tea with full fat milk and Water in people with Gastric Emptying, run by Coombe Women and Infants University Hospital at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric emptying at 2 hours - supine. (time frame: 120 mins). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03694509, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2019.