Assessment of Fetal Position in Active Labor (U/S)

November 8, 2017 updated by: Jennifer Goldkamp, MD, St. Louis University

Ultrasound Examination as a Teaching Tool for Vaginal Exam Assessment of Fetal Position in Active Labor

Vaginal exams are used routinely in labor to assess cervical dilation and position of the baby (facing anterior, facing to the right or left side, facing towards maternal spine). This technique has a widely variable accuracy rate (24.0-85.6%). Ultrasound has been used to help confirm or correct the vaginal assessment by obstetricians, but has not been used to assess the utility of immediate feedback to improve the accuracy of vaginal assessment by physicians in training. The investigators plan to use ultrasound assessment to determine if this education is effective in increasing accuracy in the resident population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

12

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 26 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

3rd and 4th year Ob, Gyn Residents

Description

Inclusion Criteria:

  • Physicians in obstetrics training -

Exclusion Criteria:

  • Physicians outside of obstetrics training.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

August 3, 2016

First Submitted That Met QC Criteria

August 9, 2016

First Posted (Estimate)

August 12, 2016

Study Record Updates

Last Update Posted (Actual)

November 13, 2017

Last Update Submitted That Met QC Criteria

November 8, 2017

Last Verified

November 1, 2017

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)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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