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Enhanced vs. Routine Clear Liquid Intake in Labor

Primary Purpose

Abnormal Labor, Failed Induction of Labor, Ketosis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Accel Gel

Usual clear diet

About this trial

This is an interventional prevention trial for Abnormal Labor focused on measuring Abnormal Labor, Prolonged Induction, Ketosis, Diet

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts 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

Sites / Locations

Temple University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Usual Clear Diet

Accel Gel

Arm Description

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

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

Outcomes

Primary Outcome Measures

Time from admission to delivery

Up to 3 days from time of admission

Secondary Outcome Measures

Duration of second stage of labor

Time of complete cervical dilation to delivery of infant

delivery in <24 hours

cesarean delivery

rate of composite adverse GI outcome (vomiting or diarrhea)

Any vomiting or diarrhea

patient satisfaction with diet

Urine Ketones

Full Information

NCT ID

NCT02524002

First Posted

August 15, 2014

Last Updated

June 8, 2018

Sponsor

Temple University

Collaborators

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT02524002

Brief Title

Enhanced vs. Routine Clear Liquid Intake in Labor

Official Title

Clear Liquids vs Enhanced Clear Liquids; Effect on Labor Performance

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Completed

Study Start Date

August 2014 (undefined)

Primary Completion Date

July 2017 (Actual)

Study Completion Date

July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Temple University

Collaborators

Stanford University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Abnormal Labor, Failed Induction of Labor, Ketosis

Keywords

Abnormal Labor, Prolonged Induction, Ketosis, Diet

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

76 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Usual Clear Diet

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Accel Gel

Arm Type

Experimental

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

Accel Gel

Intervention Description

Accel Gel by PacificHealth Labs in Matawan, NJ.

Intervention Type

Dietary Supplement

Intervention Name(s)

Usual clear diet

Intervention Description

Usual clear liquids

Primary Outcome Measure Information:

Title

Time from admission to delivery

Description

Up to 3 days from time of admission

Time Frame

Participants will be followed during labor until delivery, an expected range of 1-48 hours

Secondary Outcome Measure Information:

Title

Duration of second stage of labor

Description

Time of complete cervical dilation to delivery of infant

Time Frame

Participants will be followed during labor until delivery, an expected range of 1-48 hours

Title

delivery in <24 hours

Time Frame

Participants will be followed during labor until delivery, an expected range of 1-48 hours

Title

cesarean delivery

Time Frame

Participants will be followed during labor until delivery, an expected range of 1-48 hours

Title

rate of composite adverse GI outcome (vomiting or diarrhea)

Description

Any vomiting or diarrhea

Time Frame

Participants will be followed for the duration of hospital stay, an expected average of 5 days

Title

patient satisfaction with diet

Time Frame

Participants will be followed during labor until delivery, an expected range of 1-48 hours

Title

Urine Ketones

Time Frame

Participants will be followed during labor until full dilation, an expected range of 1-48 hours

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laura Goetzl, M.D.

Organizational Affiliation

Temple University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Temple University Hospital

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19102

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

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Enhanced vs. Routine Clear Liquid Intake in Labor

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