- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02865057
Assessment of Fetal Position in Active Labor (U/S)
Ultrasound Examination as a Teaching Tool for Vaginal Exam Assessment of Fetal Position in Active Labor
Study Overview
Detailed Description
Residents will be informed of the study through an education session (as a group) and then be consented individually. Each resident will complete 15 baseline exams, 20 exams with immediate ultrasound confirmation, and 15 exams for post-test baseline. Exams will take place periodically throughout the year. Both 3rd and 4th year residents will be assessed during the same time period by the MFM fellows. Ultrasounds will follow the vaginal exam as closely as possible to prepare for delivery. A picture of the fetal position (with no name or MRN) for documentation to be taken during the SOC ultrasound and kept in the research chart for the resident.
In training feedback is not always standard. This teaching tool, consistent and standard feedback with regard to the correlation between vaginal exam and ultrasound, would allow the resident to learn to assess fetal position more accurately.
Information from the maternal chart (history and delivery information) will be collected as de identified. Data will be recorded on the data collection sheet which is labeled with a code number linking the resident participant only.
Data collected from the residents will be assigned a random Code numbers used to link the subject to their data.
Code and identifiers will be kept separate. Paper copies will be kept in a locked cabinet, in a locked office, in a locked suite.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Physicians in obstetrics training -
Exclusion Criteria:
- Physicians outside of obstetrics training.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
3rd year Residents
3rd year Ob, Gyn Residents
|
Vaginal assessment of position prior to delivery
|
|
4th Year Residents
4th year Ob, Gyn Residents
|
Vaginal assessment of position prior to delivery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
assessing fetal position
Time Frame: Immediate
|
Categorical variables will be expressed as frequencies and percentages.
Continuous variables will be expressed as means and standard deviations and/or medians and ranges.
Demographic characteristics will be assessed using chi-square test and Fischer's Exact test for categorical variables.
To examine improvement in the number of correct physical exams from baseline to post-intervention a repeated measures t-test or Wilcoxon signed rank test will be performed.
An independent measures t-test or Mann-Whitney U test will be performed to compare the number of correct physical exams between resident groups.
Other pertinent statistical tests will be utilized as needed to account for group differences and control for variables of interest.
|
Immediate
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 26057
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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