Back to resultsEffect of a Commercially Available Carbohydrate Rich Gel on Maternal Fatigue: A Randomized Controlled Trial
Primary Purpose
Effect of Carbohydrate Ingestion During Active Labor
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
energy gel
Sponsored by
About this trial
This is an interventional supportive care trial for Effect of Carbohydrate Ingestion During Active Labor
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
energy gel
control
Arm Description
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
women will be given only clear liquids during labor
Outcomes
Primary Outcome Measures
Fatigue
evaluated by visual analog scale
duration of labor
will measure time to delivery and duration of 2nd stage of labor
Secondary Outcome Measures
Full Information
NCT ID
NCT02642588
First Posted
December 24, 2015
Last Updated
May 2, 2022
Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Melissa March, Alison Bauer, Gaetan Pettigrew, Daisy Hassani, Celina Cunanan
1. Study Identification
Unique Protocol Identification Number
NCT02642588
Brief Title
Effect of a Commercially Available Carbohydrate Rich Gel on Maternal Fatigue: A Randomized Controlled Trial
Official Title
Effect of a Commercially Available Carbohydrate Rich Gel on Maternal Fatigue: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Study never started
Study Start Date
August 2016 (undefined)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
January 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Melissa March, Alison Bauer, Gaetan Pettigrew, Daisy Hassani, Celina Cunanan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Effect of Carbohydrate Ingestion During Active Labor
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
energy gel
Arm Type
Experimental
Arm Description
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
Arm Title
control
Arm Type
No Intervention
Arm Description
women will be given only clear liquids during labor
Intervention Type
Dietary Supplement
Intervention Name(s)
energy gel
Intervention Description
energy gel: gelatinous edible containing carbohydrates typically used during endurance races
Primary Outcome Measure Information:
Title
Fatigue
Description
evaluated by visual analog scale
Time Frame
every 2 hours until delivery
Title
duration of labor
Description
will measure time to delivery and duration of 2nd stage of labor
Time Frame
from start of active phase until delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
Effect of a Commercially Available Carbohydrate Rich Gel on Maternal Fatigue: A Randomized Controlled Trial
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