Gastric Emptying of Water and Sports Drink in Labor

NCT ID: NCT04229043

Last Updated: 2025-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pregnancy Gastric Emptying

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Early labor, no analgesia: Sports drink

Subject will ingest 100 ml of a carbohydrate sports drink

Group Type ACTIVE_COMPARATOR

Sports drink

Intervention Type DIETARY_SUPPLEMENT

Drink that will be ingested

Early Labor, no analgesia: Water

Subject will ingest 100 ml of water

Group Type PLACEBO_COMPARATOR

Water

Intervention Type DIETARY_SUPPLEMENT

Drink that will be ingested

Early labor, analgesia: Sports drink

Subject will ingest 100 ml of a carbohydrate sports drink

Group Type ACTIVE_COMPARATOR

Sports drink

Intervention Type DIETARY_SUPPLEMENT

Drink that will be ingested

Early labor, analgesia: Water

Subject will ingest 100 ml of water

Group Type PLACEBO_COMPARATOR

Water

Intervention Type DIETARY_SUPPLEMENT

Drink that will be ingested

Interventions

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Sports drink

Drink that will be ingested

Intervention Type DIETARY_SUPPLEMENT

Water

Drink that will be ingested

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Phillip Hess

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beth Isreal Deaconess Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Diana Cepeda

Role: primary

6176674113

Other Identifiers

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2019P001110

Identifier Type: -

Identifier Source: org_study_id

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