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

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University of Pittsburgh

Status

Completed

Conditions

Emesis

Treatments

Other: Protein Shake

Study type

Interventional

Funder types

Other

Identifiers

NCT01414478
PRO10070074

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 patients

Sex

Female

Ages

14 to 50 years old

Volunteers

Accepts 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).

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

150 participants in 2 patient groups

High Protein Shake
Active Comparator group
Description:
Protein shake that contain 30 grams of protein in 11 fluid ounces.
Treatment:
Other: Protein Shake
Ice Chips
No Intervention group
Description:
Patients allowed consumption of ice chips only during labor.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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