Gastric Emptying of Water and Sports Drink in Labor
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorBeth Israel Deaconess Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Recent food ingestion (<3 hours)
Preeclampsia
Receiving magnesium sulfate
Having received narcotics within 12 hours
Trial design
Design model
Parallel
Treatments tested in this trial
Sports drink
Dietary supplementDrink that will be ingested
Water
Dietary supplementDrink that will be ingested
Treatment groups
108 Participants
are divided into 4 treatment groupsGroup A: Early labor, no analgesia: Sports drinkActive comparator 1 intervention
Group B: Early Labor, no analgesia: WaterPlacebo comparator 1 intervention
Group C: Early labor, analgesia: Sports drinkActive comparator 1 intervention
Group D: Early labor, analgesia: WaterPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Gastric emptying half time
The time in minutes that half of the volume of the stomach has emptied
Time frame
60 minutesSecondary outcomes
1
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'
Time frame
60 minutesSponsors and contacts
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Source ClinicalTrials.gov