- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01414478
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
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- Magee-Womens Hospital Women Care Birth Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: High Protein Shake
Protein shake that contain 30 grams of protein in 11 fluid ounces.
|
Protein shake contains 30 grams of protein in 11 fluid ounces.
Other Names:
|
No Intervention: Ice Chips
Patients allowed consumption of ice chips only during labor.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Throughout labor (up to one hour post delivery)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Throughout labor (up to 24 hours post delivery)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Manuel C Vallejo, MD, University of Pittsburgh
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO10070074
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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