Ultrasound Assessment of Gastric Emptying

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01672424
First received: August 21, 2012
Last updated: February 1, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Pregnancy
Other: Ice Chips
Other: Protein Drink

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Ultrasound Assessment of Gastric Emptying Following the Addition of a High Protein Drink vs Ice Chips During Labor

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Gastric Emptying [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Gastric emptying will be measured with ultrasounds every twenty minutes for two hours


Enrollment: 18
Study Start Date: May 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group P: High Protein Drink
Patients receiving the high protein drink with 30 grams of protein in 11 fluid ounces.
Other: Protein Drink
Patients will receive 11 ounces of a protein shake which contains 30 grams of protein
Other Name: Premier Nutrition Protein Shake (TM)
Group C: Ice Chips
The control group consisting patient receiving 11 ounces of ice chips
Other: Ice Chips
11 ounces of ice chips given to the laboring parturient

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   14 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Criteria

Inclusion Criteria:

  • 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

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)
  • 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)
  • No exclusion criteria shall be based on race and ethnicity
  • Men will not be included since they cannot become pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01672424

Locations
United States, Pennsylvania
UPMC Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Manuel C Vallejo, MD Physician Services Division (UPP and CMI) | UPP | Anesthesiology and Pain Medicine
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01672424     History of Changes
Other Study ID Numbers: PRO11090441
Study First Received: August 21, 2012
Last Updated: February 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
NPO
Gastric Emptying
Ice Chips
Protein Drink
Ultrasound

ClinicalTrials.gov processed this record on October 21, 2014