Gastric Emptying of Water and Sports Drink in Labor
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sports drink, Water.
- Who it may be relevant to
- Registry conditions: Pregnancy, Gastric Emptying. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Examining the Gastric Emptying Halftime of Water Versus a Carbohydrate in Early Labor
Overview
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 supplement Sports drink
Drink that will be ingested - Dietary supplement Water
Drink that will be ingested
Primary outcome measures
- Gastric emptying half time [Time frame: 60 minutes]
Secondary outcome measures (1)
- Hunger [Time frame: 60 minutes]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Beth Isreal Deaconess Medical Center — Boston
Identifiers
NCT: NCT04229043 · 2019P001110