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

NCT ID: NCT03280706

Last Updated: 2018-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-09

Study Completion Date

2018-02-02

Brief Summary

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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

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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.

Conditions

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Gastric Emptying Pregnancy Vomits

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Investigator and outcomes assessor will not know to which group each woman was allocated

Study Groups

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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.

Group Type EXPERIMENTAL

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin 50g in water 500ml

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.

Group Type ACTIVE_COMPARATOR

Orange Juice

Intervention Type DIETARY_SUPPLEMENT

Orange juice 480ml + 20ml of water

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.

Group Type ACTIVE_COMPARATOR

Coffee with milk

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Maltodextrin

Maltodextrin 50g in water 500ml

Intervention Type DIETARY_SUPPLEMENT

Orange Juice

Orange juice 480ml + 20ml of water

Intervention Type DIETARY_SUPPLEMENT

Coffee with milk

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Brasilia University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gabriel Magalhaes Nunes Guimaraes

Head of anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gabriel MN Guimaraes, MsC

Role: STUDY_CHAIR

Hospital Universitario de Brasilia

Locations

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University Hospital of Brasilia University

Brasília, Federal District, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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tcc-anele-2017

Identifier Type: -

Identifier Source: org_study_id

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