Status:
COMPLETED
High Protein Intake to Decrease Emesis and Promote Patient Satisfaction in Labor
Lead Sponsor:
University of Pittsburgh
Conditions:
Emesis
Eligibility:
FEMALE
14-50 years
Phase:
NA
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 dissat...
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 num...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01414478
Start Date
August 1 2010
End Date
August 1 2012
Last Update
February 4 2013
Active Locations (1)
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1
Magee-Womens Hospital Women Care Birth Center
Pittsburgh, Pennsylvania, United States, 15213