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

University Hospitals (UH)

Status: Withdrawn

Conditions: Effect of Carbohydrate Ingestion During Active Labor

Treatments: Dietary Supplement: energy gel

Study type: Interventional

Funder types: Other

Identifiers

NCT02642588

UHCaseMC

Details and patient eligibility

About

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.

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

energy gel

Experimental group

Description:

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

Treatment:

Dietary Supplement: energy gel

control

No Intervention group

Description:

women will be given only clear liquids during labor