Effect of a Commercially Available Carbohydrate Rich Gel on Maternal Fatigue: A Randomized Contro… (NCT02642588) | Clinical Trial Compass
WithdrawnNot Applicable
Effect of a Commercially Available Carbohydrate Rich Gel on Maternal Fatigue: A Randomized Controlled Trial
Stopped: Study never started
0Started 2016-08
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Fatigue
Timeframe: every 2 hours until delivery
2
duration of labor
Timeframe: from start of active phase until delivery
Trial details
NCT IDNCT02642588
SponsorUniversity Hospitals Cleveland Medical Center