Gastric Emptying of Water and Sports Drink in Labor

Beth Israel Lahey Health

Status: Enrolling

Conditions: Gastric Emptying; Pregnancy

Treatments: Dietary Supplement: Sports drink; Dietary Supplement: Water

Study type: Interventional

Funder types: Other

Identifiers

NCT04229043

2019P001110

Details and patient eligibility

About

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.

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.

Enrollment: 108 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 4 patient groups, including a placebo group

Early labor, no analgesia: Sports drink

Active Comparator group

Description:

Subject will ingest 100 ml of a carbohydrate sports drink

Treatment:

Dietary Supplement: Sports drink

Early Labor, no analgesia: Water

Placebo Comparator group

Description:

Subject will ingest 100 ml of water

Treatment:

Dietary Supplement: Water

Early labor, analgesia: Sports drink

Active Comparator group

Description:

Subject will ingest 100 ml of a carbohydrate sports drink

Treatment:

Dietary Supplement: Sports drink

Early labor, analgesia: Water

Placebo Comparator group

Description:

Subject will ingest 100 ml of water

Treatment:

Dietary Supplement: Water