ClinicalTrials.Veeva

Menu

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

University Hospitals (UH) logo

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Withdrawn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)

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

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems