NCT02865057

Brief 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%). 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 12, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

November 13, 2017

Status Verified

November 1, 2017

Enrollment Period

1.1 years

First QC Date

August 3, 2016

Last Update Submit

November 8, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Immediate

Study Arms (2)

3rd year Residents

3rd year Ob, Gyn Residents

Procedure: Vaginal assessment

4th Year Residents

4th year Ob, Gyn Residents

Procedure: Vaginal assessment

Interventions

Vaginal assessment of position prior to delivery

3rd year Residents4th Year Residents

Eligibility Criteria

Age21 Years - 26 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

3rd and 4th year Ob, Gyn Residents

You may qualify if:

  • Physicians in obstetrics training -

You may not qualify if:

  • Physicians outside of obstetrics training.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Jennifer Goldkamp, MD

    St. Louis University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MFM Fellow

Study Record Dates

First Submitted

August 3, 2016

First Posted

August 12, 2016

Study Start

August 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

November 13, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share