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

Brasilia University Hospital54 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Gastric Emptying Pregnancy Vomits

Interventions

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)

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital of Brasilia University

Brasília, Federal District, Brazil

Outcomes

Primary Outcomes

Change from Baseline Gastric antral area

Change from Baseline Gastric antral area measured by ultrasound

Time frame: baseline (before drinking allocated solution), 30, 60, 90 and 120 minutes after drinking.

Data from ClinicalTrials.gov

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