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NCT Number: NCT04229043

Gastric Emptying of Water and Sports Drink in 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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Beth Isreal Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location status: Recruiting

Location contact

Diana Cepeda

CONTACT

[email protected]

6176674113

Kowalczyk John, MD

SUB_INVESTIGATOR

Sween Lindsay, MD

SUB_INVESTIGATOR

Yunping Li, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sports drink

Dietary Supplement

Drink that will be ingested

Water

Dietary Supplement

Drink that will be ingested

Primary outcomes

  1. Gastric emptying half time

    Time frame: 60 minutes

    The time in minutes that half of the volume of the stomach has emptied

Secondary outcomes

  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'

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jan 14, 2020
Registry last updated
Oct 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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