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
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Gastric Emptying
• Pregnancy

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