High Protein Intake to Decrease Emesis and Promote Patient Satisfaction in Labor
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||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|
- Emesis in labor [ Time Frame: Throughout labor (up to one hour post delivery) ] [ Designated as safety issue: No ]To determine the incidence of emesis after high protein intake in parturients who have received labor epidural analgesia up until one hour post delivery.
- Patient satisfaction with labor after consumption of a high protein shake. [ Time Frame: Throughout labor (up to 24 hours post delivery) ] [ Designated as safety issue: No ]Our secondary aim is to determine the incidence of nausea after high protein intake during labor and overall parturient satisfaction with their birthing experience 24 hours post delivery.
|Study Start Date:||August 2010|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Active Comparator: High Protein Shake
Protein shake that contain 30 grams of protein in 11 fluid ounces.
Other: Protein Shake
Protein shake contains 30 grams of protein in 11 fluid ounces.
Other Name: Premier Nutrition Protein Shake
No Intervention: Ice Chips
Patients allowed consumption of ice chips only during labor.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01414478
|United States, Pennsylvania|
|Magee-Womens Hospital Women Care Birth Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Manuel C Vallejo, MD||Magee Womens Hospital of UPMC|