Effect of a Commercially Available Carbohydrate Rich Gel on Maternal Fatigue: A Randomized Controlled Trial

Study Overview
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Brief Summary
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Women in active labor will be given energy gel at 45-60 minute intervals and their fatigue level will be compared to women receiving usual practice care i.e. clear liquids only.

Official Title
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Effect of a Commercially Available Carbohydrate Rich Gel on Maternal Fatigue: A Randomized Controlled Trial

Conditions
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Effect of Carbohydrate Ingestion During Active Labor

Intervention / Treatment
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* Dietary Supplement: energy gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be 18 years or older as well as willing and able to provide informed consent Patients with BMI < 35 kg/m^2 Gestational age >37 weeks Exclusion Criteria: - Patients younger than 18 years, Patients unable or unwilling to provide informed consent, Patients who are illiterate, Patients who are non-English speaking or reading, Patients who are University Hospital employees, Patients undergoing induction of labor for maternal or fetal indications other than elective induction after 39 weeks or induction for post-term pregnancy Multi-fetal gestations (>1 intrauterine pregnancy), Patients with a history of GI disorders such as hyperemesis gravidarum, inflammatory bowel disease or irritable bowel syndrome Patients with an increased risk of aspiration such as BMI >35 kg/m^2, severe GERD, gastroesophageal motility disorders, Patients with acute or chronic platelet dysfunction (e.g.: idiopathic thrombocytopenic purpura, HELLP syndrome) which may necessitate need for general anesthetic for Cesarean delivery Patients with history of peptic ulcer disease, Patients who have a contraindication to epidural placement and would require general anesthestetic in event of Cesarean delivery Patients with suspected or proven placenta accreta, increta or percreta, Patients with excessive nausea or vomiting during labor Patients with a history of food allergies or allergies to specific components found in the energy gel.

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: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: energy gel<br>women will be given 22 g of carbohydrates every 45-60 minutes for up to 8 hours or until delivery during the active phase of labor | Dietary Supplement: energy gel<br>* energy gel: gelatinous edible containing carbohydrates typically used during endurance races<br>|
| No Intervention: control<br>women will be given only clear liquids during labor | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue | evaluated by visual analog scale | every 2 hours until delivery | 
| duration of labor | will measure time to delivery and duration of 2nd stage of labor | from start of active phase until delivery |