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

Gastric Emptying Clinical Trial

— GEMCO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03280706
• Other study ID #: tcc-anele-2017
• Status: Completed
• Phase: N/A
• First received: September 9, 2017
• Last updated: February 6, 2018
• Start date: September 9, 2017
• Est. completion date: February 2, 2018

Study information

• Verified date: February 2018
• Source: Brasilia University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: February 2, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Emptying
• Pregnancy Vomits

Intervention

Dietary Supplement:
• Maltodextrin
Maltodextrin 50g in water 500ml
• Orange Juice
Orange juice 480ml + 20ml of water
• Coffee with milk
Coffee with milk (330 ml of milk + 220 of water)

Locations

Country	Name	City	State
Brazil	University Hospital of Brasilia University	Brasilia	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
Brasilia University Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Gastric antral area	Change from Baseline Gastric antral area measured by ultrasound	baseline (before drinking allocated solution), 30, 60, 90 and 120 minutes after drinking.

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