Enhanced vs. Routine Clear Liquid Intake in Labor

NCT ID: NCT02524002

Last Updated: 2018-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-07-31

Brief Summary

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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

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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.

Conditions

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Abnormal Labor Failed Induction of Labor Ketosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Usual Clear Diet

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

Group Type PLACEBO_COMPARATOR

Usual clear diet

Intervention Type DIETARY_SUPPLEMENT

Usual clear liquids

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

Group Type EXPERIMENTAL

Accel Gel

Intervention Type DIETARY_SUPPLEMENT

Accel Gel by PacificHealth Labs in Matawan, NJ.

Interventions

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Accel Gel

Accel Gel by PacificHealth Labs in Matawan, NJ.

Intervention Type DIETARY_SUPPLEMENT

Usual clear diet

Usual clear liquids

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role collaborator

Temple University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura Goetzl, M.D.

Role: PRINCIPAL_INVESTIGATOR

Temple University Hospital

Locations

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Temple University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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22375

Identifier Type: -

Identifier Source: org_study_id

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