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

Primary Purpose

Emesis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Protein Shake
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Emesis focused on measuring emesis, nausea

Eligibility Criteria

14 Years - 50 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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).

Sites / Locations

  • Magee-Womens Hospital Women Care Birth Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

High Protein Shake

Ice Chips

Arm Description

Protein shake that contain 30 grams of protein in 11 fluid ounces.

Patients allowed consumption of ice chips only during labor.

Outcomes

Primary Outcome Measures

Emesis in labor
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.
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.

Full Information

First Posted
August 9, 2011
Last Updated
February 1, 2013
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT01414478
Brief Title
High Protein Intake to Decrease Emesis and Promote Patient Satisfaction in Labor
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 Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pittsburgh

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emesis
Keywords
emesis, nausea

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Protein Shake
Arm Type
Active Comparator
Arm Description
Protein shake that contain 30 grams of protein in 11 fluid ounces.
Arm Title
Ice Chips
Arm Type
No Intervention
Arm Description
Patients allowed consumption of ice chips only during labor.
Intervention Type
Other
Intervention Name(s)
Protein Shake
Other Intervention Name(s)
Premier Nutrition Protein Shake
Intervention Description
Protein shake contains 30 grams of protein in 11 fluid ounces.
Primary Outcome Measure Information:
Title
Emesis in labor
Description
To determine the incidence of emesis after high protein intake in parturients who have received labor epidural analgesia up until one hour post delivery.
Time Frame
Throughout labor (up to one hour post delivery)
Secondary Outcome Measure Information:
Title
Patient satisfaction with labor after consumption of a high protein shake.
Description
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.
Time Frame
Throughout labor (up to 24 hours post delivery)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuel C Vallejo, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Magee-Womens Hospital Women Care Birth Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23551108
Citation
Vallejo MC, Cobb BT, Steen TL, Singh S, Phelps AL. Maternal outcomes in women supplemented with a high-protein drink in labour. Aust N Z J Obstet Gynaecol. 2013 Aug;53(4):369-74. doi: 10.1111/ajo.12079. Epub 2013 Apr 4.
Results Reference
derived

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

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