High Protein Intake to Decrease Emesis and Promote Patient Satisfaction in Labor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01414478
Recruitment Status : Completed
First Posted : August 11, 2011
Last Update Posted : February 4, 2013
Information provided by (Responsible Party):
University of Pittsburgh

Brief 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.

Condition or disease Intervention/treatment Phase
Emesis Other: Protein Shake Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2010
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Emesis in labor [ Time Frame: Throughout labor (up to one hour post delivery) ]
    To determine the incidence of emesis after high protein intake in parturients who have received labor epidural analgesia up until one hour post delivery.

Secondary Outcome Measures :
  1. Patient satisfaction with labor after consumption of a high protein shake. [ Time Frame: Throughout labor (up to 24 hours post delivery) ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   14 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

All women of childbearing age who request labor epidural analgesia, ≤ 5cm cervical dilatation at the time of epidural insertion, > 36 weeks gestation, singleton pregnancy, vertex presentation, and NPO more than 4 hours prior to epidural insertion. Both nulliparous and multiparous women will be included. Minors under the age of 18 years will be included and a separate informed consent will be presented to these individuals.

Exclusion Criteria:

Women with diabetes (at increased risk for gastroparesis and fetal macrosomia), multiple gestation, non-vertex fetal presentation, chronic opioid use (delayed gastric emptying), history of gastric bypass surgery (abnormal anatomical stomach), severe morbid obesity (BMI > 40kg/m2 due to increased intragastric pressure), and history of known obstetric or medical complication (i.e. preeclampsia) that may increase the likelihood of a complicated or operative delivery (i.e. cesarean section).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01414478

United States, Pennsylvania
Magee-Womens Hospital Women Care Birth Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Principal Investigator: Manuel C Vallejo, MD Magee-Womens Hospital of UPMC

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Pittsburgh Identifier: NCT01414478     History of Changes
Other Study ID Numbers: PRO10070074
First Posted: August 11, 2011    Key Record Dates
Last Update Posted: February 4, 2013
Last Verified: February 2013

Keywords provided by University of Pittsburgh:

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms