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Sports Drink vs Water for Pregnant Women in Labor
N/A
Recruiting
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
American Society of Anesthesiology Physical Status 2 or 3
Be between 18 and 65 years old
Must not have
Diabetes mellitus
Receiving magnesium sulfate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 minutes
Summary
This trial looks at how long it takes for women in early labor to empty their stomachs when given water or a carbohydrate-based sports drink, with and without epidural pain relief.
Who is the study for?
This trial is for pregnant women who are at least 36 weeks along, have a single baby, and are either being induced or in early labor with less than 6cm dilation. They should be relatively healthy as judged by anesthesiology standards.
What is being tested?
The study aims to compare how fast the stomach empties when drinking water versus a carbohydrate-based sports drink during early labor, with and without epidural pain relief.
What are the potential side effects?
Since this trial involves common beverages like water and sports drinks, side effects are minimal but may include discomfort from drinking on a full stomach or nausea.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a mild to severe systemic disease.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have diabetes.
Select...
I am currently taking magnesium sulfate.
Select...
I am currently experiencing nausea or acid reflux.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 minutes
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Gastric emptying half time
Secondary study objectives
Hunger
Trial Design
4Treatment groups
Active Control
Placebo Group
Group I: Early labor, analgesia: Sports drinkActive Control1 Intervention
Subject will ingest 100 ml of a carbohydrate sports drink
Group II: Early labor, no analgesia: Sports drinkActive Control1 Intervention
Subject will ingest 100 ml of a carbohydrate sports drink
Group III: Early labor, analgesia: WaterPlacebo Group1 Intervention
Subject will ingest 100 ml of water
Group IV: Early Labor, no analgesia: WaterPlacebo Group1 Intervention
Subject will ingest 100 ml of water
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Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
853 Previous Clinical Trials
12,929,841 Total Patients Enrolled
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