Enhanced vs. Routine Clear Liquid Intake in Labor

Study Overview
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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.

Official Title
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Clear Liquids vs Enhanced Clear Liquids; Effect on Labor Performance

Conditions
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Ketosis, Abnormal Labor, Failed Induction of Labor

Intervention / Treatment
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* Dietary Supplement: Accel Gel
* Dietary Supplement: Usual clear diet


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from admission to delivery | 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 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 |  | Participants will be followed during labor until delivery, an expected range of 1-48 hours | 
| 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) | Any vomiting or diarrhea | Participants will be followed for the duration of hospital stay, an expected average of 5 days | 
| patient satisfaction with diet |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abnormal Labor, Prolonged Induction, Ketosis, Diet