Short Anovaginal Distance is Associated… | Clinical Trial

Key information

Conditions

Perineal Tear Obstetric Trauma

Sex eligibility

Female

Study type

Observational

About this study

Background: Objective diagnostic methods for obstetric anal sphincter rupture, (OASR) such as endoanalt ultrasound (EAUS), show missed ruptures that can lead to anal incontinence. To perform EAUS after all deliveries at all hours, although it may lead to diagnostic improvement is not feasible in most delivery wards. Another objective method for screening women after delivery to identify OASR would be of value. Bidigital palpation of the perineum is often suggested without specifying what results are relevant.

AIM:

The aim of this study was to establish if the palpated anovaginal distance after delivery could be confirmed by perineal ultrasound and correlated to the extent of the perineal tear.

MATERIALS AND METHODS:

A structured educational programme for midwives (palpation) and doctors (perineal ultrasound) was accomplished. Midwives were instructed to record the palpated anovaginal distance in primiparae with spontaneous vaginal delivery and no episiotomy. If the AVD was found to be shorter than 2 cm, she recorded a primary diagnosis of probable grade 2, suspected grade 3 or probable grade 3 and called the doctor. The AVD was then measured by perineal ultrasound by a doctor aware of a laceration but not it´s extent, which was then established by clinical exam and perineal ultrasound.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

women who just had their firstborn child through vaginal delivery at the delivery ward at the University Hospital in Linköping, Sweden from October 2014 to January 2016.

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Exclusion criteria

inability to understand swedish

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Treatment and study plan

Bidigital palpation

Diagnostic Test

palpation of the anovaginal distance with two fingers

Perineal ultrasound

Diagnostic Test

ultrasound measurement of the anovaginal distance

Other names: Vaginal ultrasound, transperineal ultrasound

Primary outcomes

Correlation between palpated and ultrasound- measured anovaginal distance

Time frame: immediate

Does palpation give a reliable result?

Secondary outcomes

Anal Sphincter rupture incidence

Time frame: immediate

How common is anal sphincter rupture

Sponsors and collaborators

Lead sponsor

Ostergotland County Council, Sweden

Other

Registry information

Acronym: AVD and OASR

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2017
First posted: Feb 1, 2017
Registry last updated: Feb 13, 2017

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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Completed