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To determine the half time of the emptying of the stomach of women in early labor with and without epidural pain relief when drinking either water or a carbohydrate-based sports drink.
This is a randomized un-blinded study comparing the gastric emptying halftime of water versus a carbohydrate-based sports drink.
Cohorts Women in early labor who have not received pain medication will be enrolled in the study. This will be called the 'unmedicated' group. A second cohort of women who have received an epidural in early labor will be enrolled and studied using identical methods. This will be the 'epidural' group.
Study Intervention Subjects in each group will drink one of two drinks: water or sports drink. The changing volume in the stomach will be measured using ultrasound over the next 60 minutes. Subjects will be asked their degree of hunger on a 10-centimeter visual analogue scale prior to drinking, and for the next two hours at regular intervals. Subjects will be free to consume as per obstetric protocols. The study will be finished once the patient consumes food or drink, feels hunger ≥4/10, or two hours after the sports drink.
Hypothesis The primary hypothesis is that water will empty faster than the sports drink. A second hypothesis is that women with epidural pain relief will have similar gastric halftimes as women without pain medications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early labor, no analgesia: Sports drink | Active Comparator | Subject will ingest 100 ml of a carbohydrate sports drink |
|
| Early Labor, no analgesia: Water | Placebo Comparator | Subject will ingest 100 ml of water |
|
| Early labor, analgesia: Sports drink | Active Comparator | Subject will ingest 100 ml of a carbohydrate sports drink |
|
| Early labor, analgesia: Water | Placebo Comparator | Subject will ingest 100 ml of water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sports drink | Dietary Supplement | Drink that will be ingested |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gastric emptying half time | The time in minutes that half of the volume of the stomach has emptied | 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Hunger | The amount of hunger that the subject feels measured on a visual analogue 10-centimeter line, with the left (0 cm) being labeled 'No Hunger' and the right (10 cm) being labeled 'Maximum hunger' | 60 minutes |
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Inclusion Criteria:
Exclusion Criteria:
Subjects must be pregnant, at term, and in early labor
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Isreal Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
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| ID | Term |
|---|---|
| D014867 | Water |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 |
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Subjects in each group will drink one of two drinks: water or sports drink. We will measure the changing volume in the stomach using ultrasound over the next 60 minutes.
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| Water | Dietary Supplement | Drink that will be ingested |
|
| Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |