Enhanced vs. Routine Clear Liquid Intake in Labor

Temple University

Status: Completed

Conditions: Failed Induction of Labor; Ketosis; Abnormal Labor

Treatments: Dietary Supplement: Accel Gel; Dietary Supplement: Usual clear diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02524002

22375

Details and patient eligibility

About

The goal of the study is to see if the addition of a carbohydrate- and protein-enhanced gel during labor speeds labor and reduces the rate of cesarean delivery.

Full description

Patients will be randomized to placebo or experimental arm of study. In the placebo arm, patients will receive standard clear liquid diet, which includes ginger ale, variety of fruit juices, and plain soup broth. The experimental arm will receive the standard clear liquid diet, and in addition will receive Accel Gel every 3 hours while in labor.

Enrollment: 76 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Nulliparity (first baby)
• Admission with the intent to deliver vaginally
• Gestational age >36 weeks
• Age ≥ 18

Exclusion criteria

• Planned cesarean delivery
• Renal Disease
• Preeclampsia
• Diabetes (Pre-gestational or Gestational)
• Allergy to any component of sports drink
• NPO diet by physician

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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76 participants in 2 patient groups, including a placebo group

Usual Clear Diet

Placebo Comparator group

Description:

This intervention consists of soup broth, variety of juices (apple, cranberry, grape), ginger ale, water, and ice.

Treatment:

Dietary Supplement: Usual clear diet

Accel Gel

Experimental group

Description:

This intervention is an enhanced clear liquid gel is Accel Gel, produced by PacificHealth Labs of Matawan, NJ. This gel has 4:1 carb to protein ratio formula, and ingredients that are not contraindicated in pregnancy (only the flavors with minimal caffeine are used). http://www.pacifichealthlabs.com/accel-gel-all-natural-rapid-energy-gel-product.html

Treatment:

Dietary Supplement: Accel Gel