CClinicalTrials.gg
CompletedNCT03280706GEMCOUpdated Feb 7, 2018

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

An interventional study of Maltodextrin and Orange Juice in Gastric Emptying and Pregnancy Vomits, sponsored by Brasilia University Hospital. Completed at 1 site in Brazil. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2018-02-07.

Sponsored by Brasilia University Hospital · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Gastric Emptying
  • Pregnancy Vomits

Keywords

  • Gastric Emptying
  • labor
  • maltodextrin
  • orange juice
  • coffee
  • ultrasound
03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Vomiting before the end of the protocol
  • Did not drink the whole solutions
  • Ultrasound not performed for any reason
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
54 participants (actual)

Study arms

  • Experimental
    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.

    Dietary Supplement: Maltodextrin

  • Active comparator
    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.

    Dietary Supplement: Orange Juice

  • Active comparator
    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.

    Dietary Supplement: Coffee with milk

Interventions

  • Dietary supplementMaltodextrin

    Maltodextrin 50g in water 500ml

  • Dietary supplementOrange Juice

    Orange juice 480ml + 20ml of water

  • Dietary supplementCoffee with milk

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

05

What researchers measure

Primary outcomes

  1. 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.

06

Study locations

1 site
  • University Hospital of Brasilia University
    Brasilia, Distrito Federal 7000000, Brazil
07

References and documents

Individual participant data

Plan to share: Yes — Will make it available in our website

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03280706
Lead sponsor
Brasilia University Hospital
Responsible party
Gabriel Magalhaes Nunes Guimaraes (Head of anesthesiology, Brasilia University Hospital) — Principal investigator
First posted
Sep 12, 2017
Start date
Sep 9, 2017
Primary completion
Feb 1, 2018
Completion
Feb 2, 2018
Last update
Feb 7, 2018

Study contacts

Gabriel MN Guimaraes, MsC
study chair · Hospital Universitario de Brasilia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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