Short Anovaginal Distance is Associated With Obstetric Anal Sphincter Rupture

Completed

• Conditions: Obstetric Trauma; Perineal Tear
• Interventions: Diagnostic Test: Bidigital palpation; Diagnostic Test: Perineal ultrasound

• Registration Number: NCT03039582
• Lead Sponsor: Ostergotland County Council, Sweden

Brief Summary

Anovaginal distance measured by palpation and perineal ultrasound are similar.

Detailed Description

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.

Study Timeline

• Study Start: 2014-09-01
• Primary Completion: 2016-01-31
• Study Completion: 2017-01-19
• Study First Submitted: 2017-01-30
• Study First Submitted QC: 2017-01-30
• Status Verified: 2017-02
• Study First Posted: 2017-02-01
• Last Update Submitted: 2017-02-10
• Last Update Posted: 2017-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 151

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.

Exclusion Criteria

inability to understand swedish

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Probable grad 2	Bidigital palpation	Perineal laceration Probable grad 2
Probable grad 2	Perineal ultrasound	Perineal laceration Probable grad 2
Suspected grade 3	Perineal ultrasound	Perineal laceration Suspected grade 3
Suspected grade 3	Bidigital palpation	Perineal laceration Suspected grade 3
Probable grad 3	Perineal ultrasound	Perineal laceration Probable grad 3
Probable grad 3	Bidigital palpation	Perineal laceration Probable grad 3

Primary Outcome Measures

Name	Time	Method
Correlation between palpated and ultrasound- measured anovaginal distance	immediate	Does palpation give a reliable result?

Secondary Outcome Measures

Name	Time	Method
Anal Sphincter rupture incidence	immediate	How common is anal sphincter rupture