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RecruitingNCT04229043

Gastric Emptying of Water and Sports Drink in Labor

Examining the Gastric Emptying Halftime of Water Versus a Carbohydrate in Early Labor

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
108 (estimated)
Sponsor
Beth Israel Deaconess Medical Center · Academic / Other
Sex
Female
Age
18 Years – 50 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTSports drinkDrink that will be ingested
DIETARY_SUPPLEMENTWaterDrink that will be ingested

Timeline

Start date
2021-02-01
Primary completion
2027-12-31
Completion
2027-12-31
First posted
2020-01-14
Last updated
2025-10-23

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04229043. Inclusion in this directory is not an endorsement.

Gastric Emptying of Water and Sports Drink in Labor (NCT04229043) · Clinical Trials Directory