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Enhanced vs. Routine Clear Liquid Intake in Labor

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ClinicalTrials.gov Identifier: NCT02524002
Recruitment Status : Completed
First Posted : August 14, 2015
Last Update Posted : June 12, 2018
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Abnormal Labor Failed Induction of Labor Ketosis Dietary Supplement: Accel Gel Dietary Supplement: Usual clear diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Clear Liquids vs Enhanced Clear Liquids; Effect on Labor Performance
Study Start Date : August 2014
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. delivery in <24 hours [ Time Frame: Participants will be followed during labor until delivery, an expected range of 1-48 hours ]
  3. cesarean delivery [ Time Frame: Participants will be followed during labor until delivery, an expected range of 1-48 hours ]
  4. 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

  5. patient satisfaction with diet [ Time Frame: Participants will be followed during labor until delivery, an expected range of 1-48 hours ]
  6. Urine Ketones [ Time Frame: Participants will be followed during labor until full dilation, an expected range of 1-48 hours ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02524002


Locations
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United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19102
Sponsors and Collaborators
Temple University
Stanford University
Investigators
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Principal Investigator: Laura Goetzl, M.D. Temple University Hospital

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Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT02524002     History of Changes
Other Study ID Numbers: 22375
First Posted: August 14, 2015    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Temple University:
Abnormal Labor
Prolonged Induction
Ketosis
Diet
Additional relevant MeSH terms:
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Dystocia
Ketosis
Acidosis
Acid-Base Imbalance
Metabolic Diseases
Obstetric Labor Complications
Pregnancy Complications