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Completed

NCT Number: NCT03280706

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

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.

Completed

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Key information

Conditions

Gastric Emptying Pregnancy Vomits

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Brasilia University

Brasília, Federal District, 7000000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Maltodextrin

Dietary Supplement

Maltodextrin 50g in water 500ml

Orange Juice

Dietary Supplement

Orange juice 480ml + 20ml of water

Coffee with milk

Dietary Supplement

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

Primary outcomes

  1. Change from Baseline Gastric antral area

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

    Change from Baseline Gastric antral area measured by ultrasound

Sponsors and collaborators

Lead sponsor

Brasilia University Hospital

Other

Registry information

Official study title

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

Acronym: GEMCO

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 12, 2017
Registry last updated
Feb 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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