Abnormal Labor, Failed Induction of Labor, Ketosis
Conditions
Keywords
Abnormal Labor, Prolonged Induction, Ketosis, Diet
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTAccel Gel
Accel Gel by PacificHealth Labs in Matawan, NJ.
DIETARY_SUPPLEMENTUsual clear diet
Usual clear liquids
Sponsors
Stanford University
Temple University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Nulliparity (first baby) * Admission with the intent to deliver vaginally * Gestational age \>36 weeks * Age ≥ 18
Exclusion criteria
* Planned cesarean delivery * Renal Disease * Preeclampsia * Diabetes (Pre-gestational or Gestational) * Allergy to any component of sports drink * NPO diet by physician
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time from admission to delivery | Participants will be followed during labor until delivery, an expected range of 1-48 hours | Up to 3 days from time of admission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| delivery in <24 hours | Participants will be followed during labor until delivery, an expected range of 1-48 hours | — |
| cesarean delivery | Participants will be followed during labor until delivery, an expected range of 1-48 hours | — |
| Duration of second stage of labor | Participants will be followed during labor until delivery, an expected range of 1-48 hours | Time of complete cervical dilation to delivery of infant |
| patient satisfaction with diet | Participants will be followed during labor until delivery, an expected range of 1-48 hours | — |
| Urine Ketones | Participants will be followed during labor until full dilation, an expected range of 1-48 hours | — |
| rate of composite adverse GI outcome (vomiting or diarrhea) | Participants will be followed for the duration of hospital stay, an expected average of 5 days | Any vomiting or diarrhea |
Countries
United States
Outcome results
None listed