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

February 6, 2018 updated by: Gabriel Magalhaes Nunes Guimaraes, Brasilia University Hospital

Gastric Emptying of Maltodextrin Compared to Coffee With Milk and Orange Juice 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Distrito Federal
      • Brasilia, Distrito Federal, Brazil, 7000000
        • University Hospital of Brasilia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Maltodextrin 50g in water 500ml
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
Orange juice 480ml + 20ml of water
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
Coffee with milk (330 ml of milk + 220 of water)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline (before drinking allocated solution), 30, 60, 90 and 120 minutes after drinking.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brasilia University Hospital

Investigators

  • Study Chair: Gabriel MN Guimaraes, MsC, Hospital Universitário de Brasília

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2017

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 2, 2018

Study Registration Dates

First Submitted

September 9, 2017

First Submitted That Met QC Criteria

September 11, 2017

First Posted (Actual)

September 12, 2017

Study Record Updates

Last Update Posted (Actual)

February 7, 2018

Last Update Submitted That Met QC Criteria

February 6, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • tcc-anele-2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Will make it available in our website

IPD Sharing Time Frame

6 months after the end of the study

IPD Sharing Access Criteria

Open access

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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