Gastric Emptying of Water and Sports Drink in Labor

Study Overview
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Brief Summary
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To determine the half time of the emptying of the stomach of women in early labor with and without epidural pain relief when drinking either water or a carbohydrate-based sports drink.

Detailed Description
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This is a randomized un-blinded study comparing the gastric emptying halftime of water versus a carbohydrate-based sports drink. Cohorts Women in early labor who have not received pain medication will be enrolled in the study. This will be called the 'unmedicated' group. A second cohort of women who have received an epidural in early labor will be enrolled and studied using identical methods. This will be the 'epidural' group. Study Intervention Subjects in each group will drink one of two drinks: water or sports drink. The changing volume in the stomach will be measured using ultrasound over the next 60 minutes. Subjects will be asked their degree of hunger on a 10-centimeter visual analogue scale prior to drinking, and for the next two hours at regular intervals. Subjects will be free to consume as per obstetric protocols. The study will be finished once the patient consumes food or drink, feels hunger ≥4/10, or two hours after the sports drink. Hypothesis The primary hypothesis is that water will empty faster than the sports drink. A second hypothesis is that women with epidural pain relief will have similar gastric halftimes as women without pain medications.

Official Title
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Examining the Gastric Emptying Halftime of Water Versus a Carbohydrate in Early Labor

Conditions
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Pregnancy, Gastric Emptying

Intervention / Treatment
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* Dietary Supplement: Sports drink
* Dietary Supplement: Water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational age of 36 weeks or greater American Society of Anesthesiology Physical Status 2 or 3 Induction of labor or early labor (cervical dilation < 6cm) Singleton gestation Exclusion Criteria: Recent food ingestion (<3 hours) Preeclampsia Receiving magnesium sulfate Having received narcotics within 12 hours Diabetes mellitus Multiple gestations Active nausea or reflux symptoms

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects in each group will drink one of two drinks: water or sports drink. We will measure the changing volume in the stomach using ultrasound over the next 60 minutes.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early labor, no analgesia: Sports drink<br>Subject will ingest 100 ml of a carbohydrate sports drink | Dietary Supplement: Sports drink<br>* Drink that will be ingested<br>|
| Placebo Comparator: Early Labor, no analgesia: Water<br>Subject will ingest 100 ml of water | Dietary Supplement: Water<br>* Drink that will be ingested<br>|
| Active Comparator: Early labor, analgesia: Sports drink<br>Subject will ingest 100 ml of a carbohydrate sports drink | Dietary Supplement: Sports drink<br>* Drink that will be ingested<br>|
| Placebo Comparator: Early labor, analgesia: Water<br>Subject will ingest 100 ml of water | Dietary Supplement: Water<br>* Drink that will be ingested<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric emptying half time | The time in minutes that half of the volume of the stomach has emptied | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hunger | The amount of hunger that the subject feels measured on a visual analogue 10-centimeter line, with the left (0 cm) being labeled 'No Hunger' and the right (10 cm) being labeled 'Maximum hunger' | 60 minutes |