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

NCT01414478 | Completed DMC

• 1 other identifier: PRO10070074
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Emesis

Keywords

emesis; nausea

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• Patient satisfaction with labor after consumption of a high protein shake.

  Throughout labor (up to 24 hours post delivery)

Study Arms (2)

High Protein Shake

ACTIVE COMPARATOR

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

Other: Protein Shake

Ice Chips

NO INTERVENTION

Patients allowed consumption of ice chips only during labor.

Interventions

Protein Shake OTHER

Protein shake contains 30 grams of protein in 11 fluid ounces.

Also known as: Premier Nutrition Protein Shake

High Protein Shake

Eligibility Criteria

• Age: 14 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Magee-Womens Hospital Women Care Birth Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• 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.

  PMID: 23551108 DERIVED

MeSH Terms

Conditions

Vomiting; Nausea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Manuel C Vallejo, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2011
• First Posted: August 11, 2011
• Study Start: August 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: February 4, 2013

Record last verified: 2013-02

Locations

US (1)