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

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



Sponsors


Source

Brasilia University Hospital

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


Brief 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.

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.

Overall Status

Recruiting

Start Date

2017-09-09

Completion Date

2018-02-02

Primary Completion Date

2018-02-01

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Change from Baseline Gastric antral area
baseline (before drinking allocated solution), 30, 60, 90 and 120 minutes after drinking.

Enrollment

54

Conditions


Intervention

Intervention Type

Dietary Supplement

Intervention Name


Description

Maltodextrin 50g in water 500ml

Arm Group Label

Maltodextrin


Intervention Type

Dietary Supplement

Intervention Name


Description

Orange juice 480ml + 20ml of water

Arm Group Label

Orange Juice


Intervention Type

Dietary Supplement

Intervention Name


Description

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

Arm Group Label

Coffee with milk



Eligibility

Criteria

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

Gender

Female

Minimum Age

18 Years

Maximum Age

50 Years

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Gabriel MN Guimaraes, MsC
Study Chair
Hospital Universitario de Brasilia

Overall Contact

Last Name

Gabriel MN Guimaraes, MsC

Phone

+5561996455997

Email



Location

Facility

Status

Contact

University Hospital of Brasilia University
Brasilia Distrito Federal 7000000 Brazil
Recruiting
Last Name: Gabriel MN Guimaraes, MD
Phone: +55 61 99645-5997
Email: [email protected]

Location Countries

Country

Brazil


Verification Date

2017-09-01

Lastchanged Date

2017-09-11

Firstreceived Date

2017-09-09

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Brasilia University Hospital

Investigator Full Name

Gabriel Magalhaes Nunes Guimaraes

Investigator Title

Head of anesthesiology


Keywords


Has Expanded Access

No

Number Of Arms

3

Arm Group

Arm Group Label

Maltodextrin

Arm Group Type

Experimental

Description

Fasted pregnant woman with an empty stomach (assessed by ultrasound) will drink 500ml of maltodextrin 200kcal, no protein or fat, 49,5g of carbohydrate.


Arm Group Label

Orange Juice

Arm Group Type

Active Comparator

Description

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.


Arm Group Label

Coffee with milk

Arm Group Type

Active Comparator

Description

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.



Firstreceived Results Date

N/A

Acronym

GEMCO

Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Supportive Care

Masking

Double (Investigator, Outcomes Assessor)

Masking Description

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



ClinicalTrials.gov processed this data on September 12, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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