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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02642588
Enrollment
0
Registered
2015-12-30
Start date
2016-08-31
Completion date
2019-01-31
Last updated
2022-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Effect of Carbohydrate Ingestion During Active Labor

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.

Interventions

DIETARY_SUPPLEMENTenergy gel

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

Sponsors

Melissa March
CollaboratorUNKNOWN
Alison Bauer
CollaboratorUNKNOWN
Gaetan Pettigrew
CollaboratorUNKNOWN
Daisy Hassani
CollaboratorUNKNOWN
Celina Cunanan
CollaboratorUNKNOWN
University Hospitals Cleveland Medical Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Fatigueevery 2 hours until deliveryevaluated by visual analog scale
duration of laborfrom start of active phase until deliverywill measure time to delivery and duration of 2nd stage of labor

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026