Gastric Emptying, Pregnancy
Conditions
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTWater
Drink that will be ingested
DIETARY_SUPPLEMENTSports drink
Drink that will be ingested
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastric emptying half time | 60 minutes | The time in minutes that half of the volume of the stomach has emptied |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hunger | 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' |
Countries
United States
Outcome results
None listed