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Ultrasound Assessment of Gastric Emptying

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ClinicalTrials.gov Identifier: NCT01672424
Recruitment Status : Completed
First Posted : August 24, 2012
Last Update Posted : February 4, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Pregnancy Other: Ice Chips Other: Protein Drink

  Show Detailed Description

Study Design

Study Type : Observational
Actual Enrollment : 18 participants
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
Study Start Date : May 2012
Primary Completion Date : August 2012
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Gastric Emptying [ Time Frame: 2 hours ]
    Gastric emptying will be measured with ultrasounds every twenty minutes for two hours


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 50 Years   (Child, Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01672424     History of Changes
Other Study ID Numbers: PRO11090441
First Posted: August 24, 2012    Key Record Dates
Last Update Posted: February 4, 2013
Last Verified: February 2013

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