Gastric Emptying of Water and Sports Drink in Labor

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy; Gastric Emptying
• Intervention / Treatment: Dietary supplement: Sports drink; Dietary supplement: Water

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 Type: Interventional
• Enrollment (Anticipated): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Beth Isreal Deaconess Medical Center
      • Contact: Diana Cepeda; Phone Number: 617-667-4113; Email: dcepeda@bidmc.harvard.edu
      • Sub-Investigator: Yunping Li, MD
      • Sub-Investigator: Kowalczyk John, MD
      • Sub-Investigator: Sween Lindsay, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Early labor, no analgesia: Sports drink; Subject will ingest 100 ml of a carbohydrate sports drink	Dietary supplement: Sports drink; Drink that will be ingested
Placebo Comparator: Early Labor, no analgesia: Water; Subject will ingest 100 ml of water	Dietary supplement: Water; Drink that will be ingested
Active Comparator: Early labor, analgesia: Sports drink; Subject will ingest 100 ml of a carbohydrate sports drink	Dietary supplement: Sports drink; Drink that will be ingested
Placebo Comparator: Early labor, analgesia: Water; Subject will ingest 100 ml of water	Dietary supplement: Water; Drink that will be ingested

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric emptying half time	The time in minutes that half of the volume of the stomach has emptied	60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: January 10, 2020
• First Submitted That Met QC Criteria: January 13, 2020
• First Posted (Actual): January 14, 2020

Study Record Updates

• Last Update Posted (Actual): October 1, 2021
• Last Update Submitted That Met QC Criteria: September 25, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2019P001110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No