Gastric EmptyingGEMCONCT03280706
Gastric Emptying During Labor at Term: Non-inferiority Clinical Trial
A study testing Maltodextrin, Orange Juice and Coffee with milk in people with Gastric Emptying and Pregnancy Vomits, run by Brasilia University Hospital at 1 site in Brazil.
Trial summary
This study evaluates the gastric emptying of pregnant woman at term who received one of the three solutions: maltodextrin, orange juice or coffee with milk. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Gastric Emptying, Pregnancy Vomits
- What is being tested?
- Maltodextrin, Orange Juice and Coffee with milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteBrazil
- Study dates
- 9 Sep 2017to 2 Feb 2018
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnancy at term
- Fasted with an emptying stomach (assessed by ultrasound)
- During Labor
- No diabetes, esophageal disease, obesity
- Not emergency
- High risk of need of general anesthesia
Who cannot join
- Vomiting before the end of the protocol
- Did not drink the whole solutions
- Ultrasound not performed for any reason
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University Hospital of Brasilia University
Brasília, Federal District, 7000000
About this study
Official title: Gastric Emptying of Maltodextrin Compared to Coffee With Milk and Orange Juice During Labor at Term: Non-inferiority Clinical Trial
This study evaluates the gastric emptying of pregnant woman at term who received one of the three solutions: maltodextrin, orange juice or coffee with milk.
Read the detailed description
Allocation in maltodextrin, orange juice or coffee with milk will be random using sealed envelopes. Gastric ultrasound will be used for estimating gastric volume by measuring antral area in right lateral decubiti. All solutions will have the same volume and total of calories.
- Conditions
- Gastric Emptying, Pregnancy Vomits
- Being tested
- Maltodextrin, Orange Juice, Coffee with milk
- Keywords
- Gastric Emptying, labor, maltodextrin, orange juice, coffee, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaltodextrinDietary supplement
Maltodextrin 50g in water 500ml
Orange JuiceDietary supplement
Orange juice 480ml + 20ml of water
Coffee with milkDietary supplement
Coffee with milk (330 ml of milk + 220 of water)
| Study group | Role | What they receive |
|---|---|---|
| Maltodextrin | Experimental | Fasted pregnant woman with an empty stomach (assessed by ultrasound) will drink 500ml of maltodextrin 200kcal, no protein or fat, 49,5g of carbohydrate. Receives: Dietary Supplement: Maltodextrin |
| Orange Juice | Active comparator | Fasted pregnant woman with an empty stomach (assessed by ultrasound) will drink 500ml of orange juice, 200kcal, 2,82g of protein, 0,67g of fat, 47,08g of carbohydrate. Receives: Dietary Supplement: Orange Juice |
| Coffee with milk | Active comparator | Fasted pregnant woman with an empty stomach (assessed by ultrasound) will drink 500ml of coffee with milk, 200kcal, 10,6g of protein, 10,73g of fat, 14,9g of carbohydrate. Receives: Dietary Supplement: Coffee with milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Gastric antral area
Change from Baseline Gastric antral area measured by ultrasound
Measured: baseline (before drinking allocated solution), 30, 60, 90 and 120 minutes after drinking.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start9 Sep 2017
- Primary completion1 Feb 2018
- Study completion2 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brasilia University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel Magalhaes Nunes Guimaraes, Brasilia University Hospital
- Investigators
- Gabriel MN Guimaraes, MsC, Study chair, Hospital Universitario de Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03280706
- Sponsor's protocol ID
- tcc-anele-2017
- Acronym
- GEMCO
- Status last verified
- Feb 2018
- First submitted
- 9 Sep 2017
- Last updated
- 7 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will make it available in our website
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Emptying of Maltodextrin Compared to Coffee With Milk and Orange Juice During Labor at Term: Non-inferiority Clinical Trial
- ClinicalTrials.gov ID
- NCT03280706
- Acronym / sponsor ID
- GEMCO / tcc-anele-2017
- Conditions
- Gastric Emptying, Pregnancy Vomits
- Keywords
- Gastric Emptying, labor, maltodextrin, orange juice, coffee, ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Brasilia University HospitalUniversity, hospital or other
- Study start
- 9 Sep 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 2 Feb 2018 (actual)
- First posted
- 12 Sep 2017 (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.
This study evaluates the gastric emptying of pregnant woman at term who received one of the three solutions: maltodextrin, orange juice or coffee with milk.
Detailed description
Allocation in maltodextrin, orange juice or coffee with milk will be random using sealed envelopes. Gastric ultrasound will be used for estimating gastric volume by measuring antral area in right lateral decubiti. All solutions will have the same volume and total of calories.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Maltodextrin | Experimental | Dietary Supplement: MaltodextrinFasted pregnant woman with an empty stomach (assessed by ultrasound) will drink 500ml of maltodextrin 200kcal, no protein or fat, 49,5g of carbohydrate. |
| Orange Juice | Active comparator | Dietary Supplement: Orange JuiceFasted pregnant woman with an empty stomach (assessed by ultrasound) will drink 500ml of orange juice, 200kcal, 2,82g of protein, 0,67g of fat, 47,08g of carbohydrate. |
| Coffee with milk | Active comparator | Dietary Supplement: Coffee with milkFasted pregnant woman with an empty stomach (assessed by ultrasound) will drink 500ml of coffee with milk, 200kcal, 10,6g of protein, 10,73g of fat, 14,9g of carbohydrate. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Pregnancy at term
- Fasted with an emptying stomach (assessed by ultrasound)
- During Labor
- No diabetes, esophageal disease, obesity
- Not emergency
Key exclusion criteria (3 listed)
- Vomiting before the end of the protocol
- Did not drink the whole solutions
- Ultrasound not performed for any reason
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 |
|---|---|---|
| MaltodextrinMaltodextrin 50g in water 500ml | Dietary supplement | Maltodextrin |
| Orange JuiceOrange juice 480ml + 20ml of water | Dietary supplement | Orange Juice |
| Coffee with milkCoffee with milk (330 ml of milk + 220 of water) | Dietary supplement | Coffee with milk |
Primary outcome
Change from Baseline Gastric antral area
Time frame: baseline (before drinking allocated solution), 30, 60, 90 and 120 minutes after drinking.
Change from Baseline Gastric antral area measured by ultrasound
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 7 Feb 2018.
- Individual participant dataSharing planned: Yes. Will make it available in our website
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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.
Gabriel MN Guimaraes, MsC study chair
Hospital Universitario de Brasilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maltodextrin, Orange Juice and Coffee with milk in people with Gastric Emptying and Pregnancy Vomits, run by Brasilia University Hospital at 1 site in Brazil.
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 6 inclusion and 3 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 7 Feb 2018. 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 Brazil. 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?
Change from Baseline Gastric antral area (time frame: baseline (before drinking allocated solution), 30, 60, 90 and 120 minutes after drinking.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Feb 2018.