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

NCT ID: NCT02642588

Last Updated: 2022-05-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2019-01-31

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.

Conditions

Effect of Carbohydrate Ingestion During Active Labor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

energy gel

Intervention Type: DIETARY_SUPPLEMENT

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

control

women will be given only clear liquids during labor

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

energy gel

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

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Melissa March

UNKNOWN

Sponsor Role: collaborator

Alison Bauer

UNKNOWN

Sponsor Role: collaborator

Gaetan Pettigrew

UNKNOWN

Sponsor Role: collaborator

Daisy Hassani

UNKNOWN

Sponsor Role: collaborator

Celina Cunanan

UNKNOWN

Sponsor Role: collaborator

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

UHCaseMC

Identifier Type: -

Identifier Source: org_study_id