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RecruitingNCT04229043ClinicalTrials.gov record

Gastric Emptying of Water and Sports Drink in Labor

Pregnancy · Gastric Emptying

THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type
Interventional
Phase
Not applicable
Age range
18 years - 50 years
Sex eligible
Female
Healthy volunteers
Not accepted
Participants
108 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Read the full 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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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
Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Random assignment
Masking
No masking
Early labor, no analgesia: Sports drink

Subject will ingest 100 ml of a carbohydrate sports drink

Dietary Supplement: Sports drink

Early Labor, no analgesia: Water

Subject will ingest 100 ml of water

Dietary Supplement: Water

Early labor, analgesia: Sports drink

Subject will ingest 100 ml of a carbohydrate sports drink

Dietary Supplement: Sports drink

Early labor, analgesia: Water

Subject will ingest 100 ml of water

Dietary Supplement: Water

Sports drink DIETARY_SUPPLEMENT

Drink that will be ingested

Water DIETARY_SUPPLEMENT

Drink that will be ingested

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

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'

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Beth Isreal Deaconess Medical CenterBoston, Massachusetts, United StatesRecruiting
Yunping Li, MDSUB_INVESTIGATOR
Kowalczyk John, MDSUB_INVESTIGATOR
Sween Lindsay, MDSUB_INVESTIGATOR
View location on map ↗

Study team and timeline

Lead sponsor
Beth Israel Deaconess Medical Center
Study start
Feb 1, 2021 Actual
Primary completion
Dec 31, 2027 Estimated
Study completion
Dec 31, 2027 Estimated
First posted
Jan 14, 2020 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.

Official study title

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

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026