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

Not Applicable

Withdrawn

• Conditions: Effect of Carbohydrate Ingestion During Active Labor
• Interventions: Dietary Supplement: energy gel

• Registration Number: NCT02642588
• Lead Sponsor: University Hospitals Cleveland Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-24
• Study First Submitted QC: 2015-12-29
• Study First Posted: 2015-12-30
• Study Start: 2016-08
• Primary Completion: 2018-02
• Study Completion: 2019-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-02
• Last Update Posted: 2022-05-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
energy gel	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

Primary Outcome Measures

Name	Time	Method
Fatigue	every 2 hours until delivery	evaluated by visual analog scale
duration of labor	from start of active phase until delivery	will measure time to delivery and duration of 2nd stage of labor