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

Not Applicable

Completed

• Conditions: Gastric Emptying; Pregnancy Vomits
• Interventions: Dietary Supplement: Orange Juice; Dietary Supplement: Maltodextrin; Dietary Supplement: Coffee with milk

• Registration Number: NCT03280706
• Lead Sponsor: Brasilia University Hospital

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.

Study Timeline

• Study Start: 2017-09-09
• Study First Submitted: 2017-09-09
• Study First Submitted QC: 2017-09-11
• Study First Posted: 2017-09-12
• Status Verified: 2018-02
• Primary Completion: 2018-02-01
• Study Completion: 2018-02-02
• Last Update Submitted: 2018-02-06
• Last Update Posted: 2018-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Orange Juice	Orange Juice	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.
Maltodextrin	Maltodextrin	Fasted pregnant woman with an empty stomach (assessed by ultrasound) will drink 500ml of maltodextrin 200kcal, no protein or fat, 49,5g of carbohydrate.
Coffee with milk	Coffee with milk	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.

Primary Outcome Measures

Name	Time	Method
Change from Baseline Gastric antral area	baseline (before drinking allocated solution), 30, 60, 90 and 120 minutes after drinking.	Change from Baseline Gastric antral area measured by ultrasound

Trial Locations

Locations (1)

University Hospital of Brasilia University; 🇧🇷 Brasilia, Distrito Federal, Brazil