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

NCT03280706 | Completed

• 1 other identifier: tcc-anele-2017
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Emptying; Pregnancy Vomits

Keywords

Gastric Emptying; labor; maltodextrin; orange juice; coffee; ultrasound

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Gastric antral area

  Change from Baseline Gastric antral area measured by ultrasound

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

Study Arms (3)

Maltodextrin

EXPERIMENTAL

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

Orange Juice

ACTIVE COMPARATOR

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

Coffee with milk

ACTIVE COMPARATOR

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

Maltodextrin DIETARY_SUPPLEMENT

Maltodextrin 50g in water 500ml

Maltodextrin

Orange Juice DIETARY_SUPPLEMENT

Orange juice 480ml + 20ml of water

Orange Juice

Coffee with milk DIETARY_SUPPLEMENT

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

Coffee with milk

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Brasilia University Hospital: lead

Study Sites (1)

University Hospital of Brasilia University

Brasília, Federal District, 7000000, Brazil

Location

MeSH Terms

Interventions

maltodextrin; Coffee; Milk

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dairy Products; Food

Study Officials

• Gabriel MN Guimaraes, MsC

  Hospital Universitario de Brasilia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator and outcomes assessor will not know to which group each woman was allocated
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of anesthesiology

Study Record Dates

• First Submitted: September 9, 2017
• First Posted: September 12, 2017
• Study Start: September 9, 2017
• Primary Completion: February 1, 2018
• Study Completion: February 2, 2018
• Last Updated: February 7, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 months after the end of the study
• Access Criteria: Open access

Locations

BR (1)