Trials / Completed
CompletedNCT01414478
High Protein Intake to Decrease Emesis and Promote Patient Satisfaction in Labor
A Prospective, Randomized Trial to Evaluate the Efficacy of High Protein Intake on the Incidence of Emesis and Promotion of Patient Satisfaction After Epidural Analgesia for Labor
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 150 (actual)
- Sponsor
- University of Pittsburgh · Academic / Other
- Sex
- Female
- Age
- 14 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
The purpose of our study is to determine if the incidence of emesis can be lowered with the addition of a high protein drink during labor. Emesis and nausea are the leading causes of parturient dissatisfaction, results in a delay of returning to normal, daily living and can hugely impact the mother's postpartum experience. To date, no studies have been done on the relationship of protein intake during labor and incidence of emesis. To the best of our knowledge, the use of a high protein drink during labor has not been evaluated in the literature.
Detailed description
The investigators plan to enroll women (n=150) who requested epidural anesthesia for labor. After placement of their labor epidural catheter, parturients will be randomized by a computer generated number table into one of two groups. Group P - high protein drink with 30 grams of protein and ice chips PRN, or Group C - control group consisting of ice chips PRN. The protein drink that will be used is Premier Nutrition Protein Shake, which contains 30 grams of protein in 11 ounces. Measured variables will include; nausea and emesis at epidural placement, at hourly intervals until delivery, and 1 hour post delivery. Nausea will be evaluated using a visual analog scale (VAS); 0 = no nausea and 10 = worst nausea ever. Episodes of emesis will be recorded as (yes/no). The parturient will be seen the day following delivery and evaluated for overall patient satisfaction. Parturients will rate their satisfaction level using a scale from 0-100 with 0=not satisfied and 100=very satisfied. The investigators believe that the incidence of emesis will be decreased in parturients who receive high protein intake during labor, and overall patient satisfaction will be increased.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Protein Shake | Protein shake contains 30 grams of protein in 11 fluid ounces. |
Timeline
- Start date
- 2010-08-01
- Primary completion
- 2012-08-01
- Completion
- 2012-08-01
- First posted
- 2011-08-11
- Last updated
- 2013-02-04
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01414478. Inclusion in this directory is not an endorsement.