EducationU/SNCT02865057
Assessment of Fetal Position in Active Labor
An observational study of Education, run by St. Louis University.
Trial summary
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%). Read more about this study
- Who is it for?
- Ages 21 to 26 years
- Conditions the study is for
- Education
- What is being tested?
- Vaginal assessment
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 26 years
- All sexes
- No healthy volunteers
- Adult
Study population: 3rd and 4th year Ob, Gyn Residents
Who may be able to join
- Physicians in obstetrics training -
Who cannot join
- Physicians outside of obstetrics training.
About this study
Official title: 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.
Read the 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.
- Conditions
- Education
- Being tested
- Vaginal assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal assessmentProcedure or surgery
Vaginal assessment of position prior to delivery
| Study group | Role | What they receive |
|---|---|---|
| 3rd year Residents | 3rd year Ob, Gyn Residents Receives: Procedure: Vaginal assessment | |
| 4th Year Residents | 4th year Ob, Gyn Residents Receives: Procedure: Vaginal assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessing fetal position
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.
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Goldkamp, MD, St. Louis University
- Investigators
- Jennifer Goldkamp, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865057
- Sponsor's protocol ID
- 26057
- Acronym
- U/S
- Status last verified
- Nov 2017
- First submitted
- 3 Aug 2016
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Examination as a Teaching Tool for Vaginal Exam Assessment of Fetal Position in Active Labor
- ClinicalTrials.gov ID
- NCT02865057
- Acronym / sponsor ID
- U/S / 26057
- Conditions
- Education
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 12 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3rd year Residents | – | Procedure: Vaginal assessment3rd year Ob, Gyn Residents |
| 4th Year Residents | – | Procedure: Vaginal assessment4th year Ob, Gyn Residents |
Who may qualify
- Ages
- 21 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 3rd and 4th year Ob, Gyn Residents
Key inclusion criteria (1 listed)
- Physicians in obstetrics training -
Key exclusion criteria (1 listed)
- Physicians outside of obstetrics training.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal assessmentVaginal assessment of position prior to delivery | Procedure or surgery | 3rd year Residents, 4th Year Residents |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Goldkamp, MD principal investigator
St. Louis University
Questions about this trial
What is this clinical trial studying?
An observational study of Education, run by St. Louis University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessing fetal position (time frame: Immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2017.