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Completed

NCT Number: NCT02943018

Anovaginal Distance, Interobserver Agreement

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

Completed

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

anovaginal distance variation

Other

Kappa calculation

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ostergotland County Council, Sweden

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2016
First posted
Oct 24, 2016
Registry last updated
Oct 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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