Gastric Emptying of Water and Sports Drink in Labor

Overview

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.

Full Title of Study: “Examining the Gastric Emptying Halftime of Water Versus a Carbohydrate in Early Labor”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2022

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.

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: Early labor, no analgesia: Sports drink
    • Subject will ingest 100 ml of a carbohydrate sports drink
  • Placebo Comparator: Early Labor, no analgesia: Water
    • Subject will ingest 100 ml of water
  • Active Comparator: Early labor, analgesia: Sports drink
    • Subject will ingest 100 ml of a carbohydrate sports drink
  • Placebo Comparator: Early labor, analgesia: Water
    • Subject will ingest 100 ml of water

Clinical Trial Outcome Measures

Primary Measures

  • Gastric emptying half time
    • Time Frame: 60 minutes
    • The time in minutes that half of the volume of the stomach has emptied

Secondary Measures

  • Hunger
    • Time Frame: 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’

Participating in This Clinical Trial

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

Gender Eligibility: Female

Subjects must be pregnant, at term, and in early labor

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Beth Israel Deaconess Medical Center
  • Provider of Information About this Clinical Study
    • Sponsor

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