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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Protein Shake | Active Comparator | Protein shake that contain 30 grams of protein in 11 fluid ounces. |
|
| Ice Chips | No Intervention | Patients allowed consumption of ice chips only during labor. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protein Shake | Other | Protein shake contains 30 grams of protein in 11 fluid ounces. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Throughout labor (up to one hour post delivery) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Throughout labor (up to 24 hours post delivery) |
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Manuel C Vallejo, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Magee-Womens Hospital Women Care Birth Center | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23551108 | Derived | 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. |
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| ID | Term |
|---|---|
| D014839 | Vomiting |
| D009325 | Nausea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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