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

Study Overview
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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.

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

Conditions
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Gastric Emptying, Pregnancy Vomits

Intervention / Treatment
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* Dietary Supplement: Maltodextrin
* Dietary Supplement: Orange Juice
* Dietary Supplement: Coffee with milk


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Maltodextrin<br>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<br>* Maltodextrin 50g in water 500ml<br>|
| Active Comparator: Orange Juice<br>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<br>* Orange juice 480ml + 20ml of water<br>|
| Active Comparator: Coffee with milk<br>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<br>* Coffee with milk (330 ml of milk + 220 of water)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ultrasound, maltodextrin, orange juice, Gastric Emptying, labor, coffee