NCT04229043

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
20mo left

Started Feb 2021

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress76%
Feb 2021Dec 2027

First Submitted

Initial submission to the registry

January 10, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

October 23, 2025

Status Verified

October 1, 2025

Enrollment Period

6.9 years

First QC Date

January 10, 2020

Last Update Submit

October 22, 2025

Conditions

PregnancyGastric Emptying

Outcome Measures

Primary Outcomes (1)

  • Gastric emptying half time

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

    60 minutes

Secondary Outcomes (1)

  • Hunger

    60 minutes

Study Arms (4)

Early labor, no analgesia: Sports drink

ACTIVE COMPARATOR

Subject will ingest 100 ml of a carbohydrate sports drink

Dietary Supplement: Sports drink

Early Labor, no analgesia: Water

PLACEBO COMPARATOR

Subject will ingest 100 ml of water

Dietary Supplement: Water

Early labor, analgesia: Sports drink

ACTIVE COMPARATOR

Subject will ingest 100 ml of a carbohydrate sports drink

Dietary Supplement: Sports drink

Early labor, analgesia: Water

PLACEBO COMPARATOR

Subject will ingest 100 ml of water

Dietary Supplement: Water

Interventions

Sports drinkDIETARY_SUPPLEMENT

Drink that will be ingested

Early labor, analgesia: Sports drinkEarly labor, no analgesia: Sports drink
WaterDIETARY_SUPPLEMENT

Drink that will be ingested

Early Labor, no analgesia: WaterEarly labor, analgesia: Water

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSubjects must be pregnant, at term, and in early labor
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Recent food ingestion (\<3 hours)
  • Preeclampsia
  • Receiving magnesium sulfate
  • Having received narcotics within 12 hours
  • Diabetes mellitus
  • Multiple gestations
  • Active nausea or reflux symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Isreal Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 10, 2020

First Posted

January 14, 2020

Study Start

February 1, 2021

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

October 23, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)