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| Name | Class |
|---|---|
| Stanford University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Clear Diet | Placebo Comparator | This intervention consists of soup broth, variety of juices (apple, cranberry, grape), ginger ale, water, and ice. |
|
| Accel Gel | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accel Gel | Dietary Supplement | Accel Gel by PacificHealth Labs in Matawan, NJ. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time from admission to delivery | Up to 3 days from time of admission | Participants will be followed during labor until delivery, an expected range of 1-48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of second stage of labor | Time of complete cervical dilation to delivery of infant | Participants will be followed during labor until delivery, an expected range of 1-48 hours |
| delivery in <24 hours |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Goetzl, M.D. | Temple University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Temple University Hospital | Philadelphia | Pennsylvania | 19102 | United States |
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| ID | Term |
|---|---|
| D004420 | Dystocia |
| D007662 | Ketosis |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Usual clear diet |
| Dietary Supplement |
Usual clear liquids |
|
| 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 |
| rate of composite adverse GI outcome (vomiting or diarrhea) | Any vomiting or diarrhea | Participants will be followed for the duration of hospital stay, an expected average of 5 days |
| 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 |
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |