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

This study is not yet open for participant recruitment.
Verified March 2017 by David Sheyn, University Hospitals Cleveland Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02642588
First Posted: December 30, 2015
Last Update Posted: March 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Melissa March
Alison Bauer
Gaetan Pettigrew
Daisy Hassani
Celina Cunanan
Information provided by (Responsible Party):
David Sheyn, University Hospitals Cleveland Medical Center
  Purpose
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.

Condition Intervention
Effect of Carbohydrate Ingestion During Active Labor Dietary Supplement: energy gel

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effect of a Commercially Available Carbohydrate Rich Gel on Maternal Fatigue: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by David Sheyn, University Hospitals Cleveland Medical Center:

Primary Outcome Measures:
  • Fatigue [ Time Frame: every 2 hours until delivery ]
    evaluated by visual analog scale

  • duration of labor [ Time Frame: from start of active phase until delivery ]
    will measure time to delivery and duration of 2nd stage of labor


Estimated Enrollment: 190
Study Start Date: August 2016
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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:

  • 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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: David Sheyn, Resident, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT02642588     History of Changes
Other Study ID Numbers: UHCaseMC
First Submitted: December 24, 2015
First Posted: December 30, 2015
Last Update Posted: March 15, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms