Ultrasound Assessment of Gastric Emptying

NCT01672424 | Completed DMC

• 1 other identifier: PRO11090441
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis: The volume of gastric contents will be the same for a high protein drink versus ice chips as measured by ultrasound at 20 minute intervals for two hours in the laboring parturient. Specific Aim: To determine the volume of gastric contents at various time intervals (every 20 minutes for 2 hours) in patients with an epidural that are given a high protein drink versus those that are given ice chips, with ultrasound.

Conditions

Pregnancy

Keywords

NPO; Gastric Emptying; Ice Chips; Protein Drink; Ultrasound

Outcome Measures

Primary Outcomes (1)

• Gastric Emptying

  Gastric emptying will be measured with ultrasounds every twenty minutes for two hours

  2 hours

Study Arms (2)

Group P: High Protein Drink

Patients receiving the high protein drink with 30 grams of protein in 11 fluid ounces.

Other: Protein Drink

Group C: Ice Chips

The control group consisting patient receiving 11 ounces of ice chips

Other: Ice Chips

Interventions

Ice Chips OTHER

11 ounces of ice chips given to the laboring parturient

Group C: Ice Chips

Protein Drink OTHER

Patients will receive 11 ounces of a protein shake which contains 30 grams of protein

Also known as: Premier Nutrition Protein Shake (TM)

Group P: High Protein Drink

Eligibility Criteria

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

Study Population

All women of childbearing age (including children aged 14 years and above) who request epidural analgesia at Magee-Womens Hospital of UPMC will be eligible to participate in the study. The racial, gender and ethnic characteristics of the proposed subject population reflects the demographics of Pittsburgh and the surrounding area and/or the patient population of the University of Pittsburgh Medical Center Health System. Every attempt will be made to recruit subjects in respective proportion to these demographics.

You may qualify if:

• All women of childbearing age (including children aged 14 years and above) who request epidural analgesia at Magee-Womens Hospital of UPMC will be eligible to participate in the study
• All participants will be recruited at Magee-Womens Hospital
• All women must present ≤ 5cm cervical dilatation at the time of epidural insertion
• \> 36 weeks gestation
• Singleton pregnancy
• Vertex presentation
• NPO ≥ 4 hours prior to epidural insertion

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)
• 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)
• Men will not be included since they cannot become pregnant

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Study Officials

• Manuel C Vallejo, MD

  Physician Services Division (UPP and CMI) | UPP | Anesthesiology and Pain Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2012
• First Posted: August 24, 2012
• Study Start: May 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: February 4, 2013

Record last verified: 2013-02

Locations

US (1)