An interventional study of Accel Gel and Usual clear diet in Abnormal Labor, Failed Induction of Labor and Ketosis, sponsored by Temple University. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-12.
Sponsored by Temple University · Not applicable, Interventional, and Prevention
The goal of the study is to see if the addition of a carbohydrate- and protein-enhanced gel during labor speeds labor and reduces the rate of cesarean delivery.
Patients will be randomized to placebo or experimental arm of study. In the placebo arm, patients will receive standard clear liquid diet, which includes ginger ale, variety of fruit juices, and plain soup broth. The experimental arm will receive the standard clear liquid diet, and in addition will receive Accel Gel every 3 hours while in labor.
Exclusion criteria:
This intervention consists of soup broth, variety of juices (apple, cranberry, grape), ginger ale, water, and ice.
Dietary Supplement: Usual clear diet
This intervention is an enhanced clear liquid gel is Accel Gel, produced by PacificHealth Labs of Matawan, NJ. This gel has 4:1 carb to protein ratio formula, and ingredients that are not contraindicated in pregnancy (only the flavors with minimal caffeine are used). http://www.pacifichealthlabs.com/accel-gel-all-natural-rapid-energy-gel-product.html
Dietary Supplement: Accel Gel
Accel Gel by PacificHealth Labs in Matawan, NJ.
Usual clear liquids
Time from admission to delivery
Up to 3 days from time of admission
Time frame: Participants will be followed during labor until delivery, an expected range of 1-48 hours
Duration of second stage of labor
Time of complete cervical dilation to delivery of infant
Time frame: Participants will be followed during labor until delivery, an expected range of 1-48 hours
delivery in <24 hours
Time frame: Participants will be followed during labor until delivery, an expected range of 1-48 hours
cesarean delivery
Time frame: Participants will be followed during labor until delivery, an expected range of 1-48 hours
rate of composite adverse GI outcome (vomiting or diarrhea)
Any vomiting or diarrhea
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
patient satisfaction with diet
Time frame: Participants will be followed during labor until delivery, an expected range of 1-48 hours
Urine Ketones
Time frame: Participants will be followed during labor until full dilation, an expected range of 1-48 hours
Plan to share: Yes
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Temple University