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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02642588
Other study ID # UHCaseMC
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date August 2016
Est. completion date January 2019

Study information

Verified date May 2022
Source University Hospitals Cleveland Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 2019
Est. primary completion date February 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Effect of Carbohydrate Ingestion During Active Labor
  • Fatigue

Intervention

Dietary Supplement:
energy gel
energy gel: gelatinous edible containing carbohydrates typically used during endurance races

Locations

Country Name City State
n/a

Sponsors (6)

Lead Sponsor Collaborator
University Hospitals Cleveland Medical Center Alison Bauer, Celina Cunanan, Daisy Hassani, Gaetan Pettigrew, Melissa March

Outcome

Type Measure Description Time frame Safety issue
Primary Fatigue evaluated by visual analog scale every 2 hours until delivery
Primary duration of labor will measure time to delivery and duration of 2nd stage of labor from start of active phase until delivery