Recruiting

Observational Study

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT04229043

Conditions

Pregnancy

Gastric Emptying

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Sports drink

Water

Study Details

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.

Conditions

Pregnancy

Gastric Emptying

Study ID

NCT04229043

Start date

Feb 1, 2021

Status verified date

Oct, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

108 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Early labor, no analgesia: Sports drink

Subject will ingest 100 ml of a carbohydrate sports drink

placebo comparator: Early Labor, no analgesia: Water

Subject will ingest 100 ml of water

active comparator: Early labor, analgesia: Sports drink

Subject will ingest 100 ml of a carbohydrate sports drink

placebo comparator: Early labor, analgesia: Water

Subject will ingest 100 ml of water

Interventions

Sports drink

Drink that will be ingested

Water

Drink that will be ingested

Primary outcome measure

  • Gastric emptying half time [ Time Frame: 60 minutes ]

Central Contacts and Locations

Locations

Beth Isreal Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Diana Cepeda

6176674113dcepeda@bidmc.harvard.edu

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

Oct 23, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2025-10-23.