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NCT04229043 Clinical Trial

Gastric Emptying of Water and Sports Drink in Labor

Pregnancy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04229043
Other study ID # 2019P001110
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2021
Est. completion date December 31, 2026

Study information
Verified date May 2024
Source Beth Israel Deaconess Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 108
Est. completion date December 31, 2026
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Sports drink
Drink that will be ingested
• Water
Drink that will be ingested

Locations
Country Name City State
United States Beth Isreal Deaconess Medical Center Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Gastric emptying half time The time in minutes that half of the volume of the stomach has emptied 60 minutes
Secondary 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' 60 minutes
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