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

Brasilia University Hospital

Status: Completed

Conditions: Gastric Emptying; Pregnancy Vomits

Treatments: Dietary Supplement: Maltodextrin; Dietary Supplement: Orange Juice; Dietary Supplement: Coffee with milk

Study type: Interventional

Funder types: Other

Identifiers

NCT03280706

tcc-anele-2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 3 patient groups

Maltodextrin

Experimental group

Description:

Fasted pregnant woman with an empty stomach (assessed by ultrasound) will drink 500ml of maltodextrin 200kcal, no protein or fat, 49,5g of carbohydrate.

Treatment:

Dietary Supplement: Maltodextrin

Orange Juice

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Orange Juice

Coffee with milk

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Coffee with milk