Assessment of Fetal Position in Active Labor | NCT02865057

Studies
Assessment of Fetal Position in Active Labor

NCT02865057

Sponsor

St. Louis University

Status

Completed

Last Update Posted

Nov 13, 2017Actual

Enrollment

12Actual

Phase

Not provided

Conditions

Education

Interventions

Vaginal assessment

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2016Actual

Primary Completion Date

Sep 2017Actual

Completion Date

Sep 2017Actual

First Submitted Date

Aug 3, 2016

First Submission Date that Met QC Criteria

Aug 9, 2016

First Posted Date

Aug 12, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2017

Last Update Posted Date

Nov 13, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jennifer Goldkamp, MD, MFM Fellow, St. Louis UniversityPrincipal Investigator

Lead Sponsor

St. Louis UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
3rd year Residents		3rd year Ob, Gyn Residents	Procedure: Vaginal assessment
4th Year Residents		4th year Ob, Gyn Residents	Procedure: Vaginal assessment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vaginal assessment	Procedure	Vaginal assessment of position prior to delivery	3rd year Residents 4th Year Residents

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Physicians in obstetrics training -

Exclusion Criteria:

Physicians outside of obstetrics training.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

26 Years

Standard Ages

Adult

Study Population

3rd and 4th year Ob, Gyn Residents

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jennifer Goldkamp, MD	St. Louis University	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided