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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01414478
First received: August 9, 2011
Last updated: February 1, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention
Emesis
 Other: Protein Shake

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 150
Study Start Date: August 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   14 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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).

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01414478

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

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01414478     History of Changes
Other Study ID Numbers: PRO10070074
Study First Received: August 9, 2011
Last Updated: February 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
emesis
nausea

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

ClinicalTrials.gov processed this record on May 19, 2013