Beth Isreal Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Location status: Recruiting
Location contact
Diana Cepeda
CONTACT
Kowalczyk John, MD
SUB_INVESTIGATOR
Sween Lindsay, MD
SUB_INVESTIGATOR
Yunping Li, MD
SUB_INVESTIGATOR
NCT Number: NCT04229043
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.
Interested in participating?
Request Info18 year–50 year
Female
Interventional
Not applicable
Boston, Massachusetts, 02215, United States
Location status: Recruiting
Diana Cepeda
CONTACT
Kowalczyk John, MD
SUB_INVESTIGATOR
Sween Lindsay, MD
SUB_INVESTIGATOR
Yunping Li, MD
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Drink that will be ingested
Drink that will be ingested
Time frame: 60 minutes
The time in minutes that half of the volume of the stomach has emptied
Time frame: 60 minutes
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'
Beth Israel Deaconess Medical Center
Other
Examining the Gastric Emptying Halftime of Water Versus a Carbohydrate in Early Labor
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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