Enhanced vs. Routine Clear Liquid Intake in Labor

June 8, 2018 updated by: Temple University

Clear Liquids vs Enhanced Clear Liquids; Effect on Labor Performance

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19102
        • Temple University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Usual Clear Diet
This intervention consists of soup broth, variety of juices (apple, cranberry, grape), ginger ale, water, and ice.
Dietary supplement: Usual clear diet
Usual clear liquids
Experimental: 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
Dietary supplement: Accel Gel
Accel Gel by PacificHealth Labs in Matawan, NJ.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time from admission to delivery
Time Frame: Participants will be followed during labor until delivery, an expected range of 1-48 hours
Up to 3 days from time of admission
Participants will be followed during labor until delivery, an expected range of 1-48 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Temple University

Collaborators

Stanford University

Investigators

  • Principal Investigator: Laura Goetzl, M.D., Temple University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

August 15, 2014

First Submitted That Met QC Criteria

August 12, 2015

First Posted (Estimate)

August 14, 2015

Study Record Updates

Last Update Posted (Actual)

June 12, 2018

Last Update Submitted That Met QC Criteria

June 8, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22375 (Other Identifier: City of Hope Comprehensive Cancer Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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