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Gastric Emptying During Labor at Term: Non-inferiority Clinical Trial

Gastric Emptying of Maltodextrin Compared to Coffee With Milk and Orange Juice During Labor at Term: Non-inferiority Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03280706
Acronym
GEMCO
Enrollment
54
Registered
2017-09-12
Start date
2017-09-09
Completion date
2018-02-02
Last updated
2018-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Emptying, Pregnancy Vomits

Keywords

Gastric Emptying, labor, maltodextrin, orange juice, coffee, ultrasound

Brief 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.

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.

Interventions

DIETARY_SUPPLEMENTMaltodextrin

Maltodextrin 50g in water 500ml

DIETARY_SUPPLEMENTOrange Juice

Orange juice 480ml + 20ml of water

DIETARY_SUPPLEMENTCoffee with milk

Coffee with milk (330 ml of milk + 220 of water)

Sponsors

Brasilia University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Investigator and outcomes assessor will not know to which group each woman was allocated

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Vomiting before the end of the protocol * Did not drink the whole solutions * Ultrasound not performed for any reason

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline Gastric antral areabaseline (before drinking allocated solution), 30, 60, 90 and 120 minutes after drinking.Change from Baseline Gastric antral area measured by ultrasound

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026