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Gastric Emptying of Water and Sports Drink in Labor

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ClinicalTrials.gov Identifier: NCT04229043
Recruitment Status : Recruiting
First Posted : January 14, 2020
Last Update Posted : October 1, 2021
Sponsor:
Information provided by (Responsible Party):
Phillip Hess, 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.

Condition or disease Intervention/treatment Phase
Pregnancy Gastric Emptying Dietary Supplement: Sports drink Dietary Supplement: Water Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects in each group will drink one of two drinks: water or sports drink. We will measure the changing volume in the stomach using ultrasound over the next 60 minutes.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Examining the Gastric Emptying Halftime of Water Versus a Carbohydrate in Early Labor
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

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




Primary Outcome Measures :
  1. Gastric emptying half time [ Time Frame: 60 minutes ]
    The time in minutes that half of the volume of the stomach has emptied


Secondary Outcome Measures :
  1. 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'



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Subjects must be pregnant, at term, and in early labor
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04229043


Locations
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United States, Massachusetts
Beth Isreal Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Diana Cepeda    617-667-4113    dcepeda@bidmc.harvard.edu   
Sub-Investigator: Yunping Li, MD         
Sub-Investigator: Kowalczyk John, MD         
Sub-Investigator: Sween Lindsay, MD         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
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Responsible Party: Phillip Hess, Principal Investigator, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT04229043    
Other Study ID Numbers: 2019P001110
First Posted: January 14, 2020    Key Record Dates
Last Update Posted: October 1, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No