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

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.

Study Overview

• Status: Withdrawn
• Conditions: Effect of Carbohydrate Ingestion During Active Labor
• Intervention / Treatment: Dietary supplement: energy gel

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: energy gel; 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; energy gel: gelatinous edible containing carbohydrates typically used during endurance races
No Intervention: control; women will be given only clear liquids during labor

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Collaborators: Melissa March; Alison Bauer; Gaetan Pettigrew; Daisy Hassani; Celina Cunanan

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Anticipated): February 1, 2018
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: December 24, 2015
• First Submitted That Met QC Criteria: December 29, 2015
• First Posted (Estimate): December 30, 2015

Study Record Updates

• Last Update Posted (Actual): May 6, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: UHCaseMC