Anovaginal Distance, Interobserver Agreement

October 21, 2016 updated by: Eva Uustal, Ostergotland County Council, Sweden

Interobserver Agreement in Perineal Ultrasound of the Anovaginal Distance- a Methodology-study

Interobserver variation in measuring the anovaginal distance (AVD) with perineal ultrasound

Study Overview

Status

Completed

Detailed Description

Aims: This study describes perineal ultrasound measurement of the AVD in regard to ease of learning and interobserver agreement, in order to establish if the method is reliable to use in further research about objective postpartum description of perineal tears.

Methods: To educate the examiners, the method was shown and described by an experienced examiner. The examiners then measured the anovaginal distance in one woman repeatedly with until similar results (+/- 5 mm ) were achieved. The woman was in the lithotomy position and a vaginal ultrasound probe was used. The AVD in another 40 women was then measured and documented by two examiners, right after the other, who were blinded to the other´s results. The distance was measured between the mucosal margin of the internal anal sphincter and the vaginal probe. Interobserver agreement was calculated using Kappa-score.

Study Type

Observational

Enrollment (Actual)

40

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

20 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The examiners whose measurements were compared for interobserver varialility were gynecologists working inte the department.

The study population to perform measurements on was recruited from women visiting the gynaecological outpatient clinic of Linköping University Hospital.

Description

Inclusion Criteria:

Examiners; the gynecologists authoring the study

Patients:

  • any women visiting the gynaecological outpatient clinic of Linköping University Hospital where a vaginal ultrasound examination was performed

Exclusion Criteria:

Examiners: n/a

Patients:

  • inability to understand spoken or written Swedish

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
anovaginal distance variation
3 measurements
Kappa calculation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
interobserver variation in measurements of the anovaginal distance with perineal ultrasound
Time Frame: immediate
3 measurements per investigator and patient, comparing variation, using kappa value
immediate

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ease of learning the technique of perineal ultrasound to measure the anovaginal distance
Time Frame: immediate
how many measurements did the investigator learning the procedure need to perform produce a measurement that was within 5 mm of the measurements of the teacher
immediate

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Marie I Blomberg, MD PhD, Head of department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

October 18, 2016

First Submitted That Met QC Criteria

October 21, 2016

First Posted (Estimate)

October 24, 2016

Study Record Updates

Last Update Posted (Estimate)

October 24, 2016

Last Update Submitted That Met QC Criteria

October 21, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OstergotlandCCAVD

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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