Enhanced vs. Routine Clear Liquid Intake in Labor

Not Applicable

Completed

• Conditions: Ketosis; Abnormal Labor; Failed Induction of Labor
• Interventions: Dietary Supplement: Accel Gel; Dietary Supplement: Usual clear diet

• Registration Number: NCT02524002
• Lead Sponsor: Temple University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-15
• Study First Submitted QC: 2015-08-12
• Study First Posted: 2015-08-14
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-08
• Last Update Posted: 2018-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 76

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Accel Gel	Accel Gel	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
Usual Clear Diet	Usual clear diet	This intervention consists of soup broth, variety of juices (apple, cranberry, grape), ginger ale, water, and ice.

Primary Outcome Measures

Name	Time	Method
Time from admission to delivery	Participants will be followed during labor until delivery, an expected range of 1-48 hours	Up to 3 days from time of admission

Secondary Outcome Measures

Name	Time	Method
delivery in <24 hours	Participants will be followed during labor until delivery, an expected range of 1-48 hours
Urine Ketones	Participants will be followed during labor until full dilation, an expected range of 1-48 hours
Duration of second stage of labor	Participants will be followed during labor until delivery, an expected range of 1-48 hours	Time of complete cervical dilation to delivery of infant
cesarean delivery	Participants will be followed during labor until delivery, an expected range of 1-48 hours
rate of composite adverse GI outcome (vomiting or diarrhea)	Participants will be followed for the duration of hospital stay, an expected average of 5 days	Any vomiting or diarrhea
patient satisfaction with diet	Participants will be followed during labor until delivery, an expected range of 1-48 hours

Trial Locations

Locations (1)

Temple University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States