Gastric Emptying of Water and Sports Drink in Labor

Not Applicable

Recruiting

• Conditions: Pregnancy; Gastric Emptying
• Interventions: Dietary Supplement: Water; Dietary Supplement: Sports drink

• Registration Number: NCT04229043
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

Study Timeline

• Study First Submitted: 2020-01-10
• Study First Submitted QC: 2020-01-13
• Study First Posted: 2020-01-14
• Study Start: 2021-02-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 108

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Labor, no analgesia: Water	Water	Subject will ingest 100 ml of water
Early labor, analgesia: Sports drink	Sports drink	Subject will ingest 100 ml of a carbohydrate sports drink
Early labor, no analgesia: Sports drink	Sports drink	Subject will ingest 100 ml of a carbohydrate sports drink
Early labor, analgesia: Water	Water	Subject will ingest 100 ml of water

Primary Outcome Measures

Name	Time	Method
Gastric emptying half time	60 minutes	The time in minutes that half of the volume of the stomach has emptied

Secondary Outcome Measures

Name	Time	Method
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'

Trial Locations

Locations (1)

Beth Isreal Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States