Short Anovaginal Distance is Associated With Obstetric Anal Sphincter Rupture (AVD and OASR)

Anovaginal distance measured by palpation and perineal ultrasound are similar.

Study Overview

• Status: Completed
• Conditions: Perineal Tear; Obstetric Trauma
• Intervention / Treatment: Diagnostic test: Bidigital palpation; Diagnostic test: Perineal ultrasound

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 Type: Observational
• Enrollment (Actual): 151

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women just after vaginal delivery

Description

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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Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Probable grad 2; Perineal laceration Probable grad 2	Diagnostic test: Bidigital palpation; palpation of the anovaginal distance with two fingers; Diagnostic test: Perineal ultrasound; ultrasound measurement of the anovaginal distance; Other Names: Vaginal ultrasound; transperineal ultrasound
Suspected grade 3; Perineal laceration Suspected grade 3	Diagnostic test: Bidigital palpation; palpation of the anovaginal distance with two fingers; Diagnostic test: Perineal ultrasound; ultrasound measurement of the anovaginal distance; Other Names: Vaginal ultrasound; transperineal ultrasound
Probable grad 3; Perineal laceration Probable grad 3	Diagnostic test: Bidigital palpation; palpation of the anovaginal distance with two fingers; Diagnostic test: Perineal ultrasound; ultrasound measurement of the anovaginal distance; Other Names: Vaginal ultrasound; transperineal ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between palpated and ultrasound- measured anovaginal distance	Does palpation give a reliable result?	immediate

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anal Sphincter rupture incidence	How common is anal sphincter rupture	immediate

Collaborators and Investigators

• Sponsor: Ostergotland County Council, Sweden

Publications and helpful links

General Publications

• Harvey MA, Pierce M, Alter JE, Chou Q, Diamond P, Epp A, Geoffrion R, Harvey MA, Larochelle A, Maslow K, Neustaedter G, Pascali D, Pierce M, Schulz J, Wilkie D, Sultan A, Thakar R; Society of Obstetricians and Gynaecologists of Canada. Obstetrical Anal Sphincter Injuries (OASIS): Prevention, Recognition, and Repair. J Obstet Gynaecol Can. 2015 Dec;37(12):1131-48. doi: 10.1016/s1701-2163(16)30081-0. Erratum In: J Obstet Gynaecol Can. 2016 Apr;38(4):421. J Obstet Gynaecol Can. 2016 Apr;38(4):421.
• Geller EJ, Robinson BL, Matthews CA, Celauro KP, Dunivan GC, Crane AK, Ivins AR, Woodham PC, Fielding JR. Perineal body length as a risk factor for ultrasound-diagnosed anal sphincter tear at first delivery. Int Urogynecol J. 2014 May;25(5):631-6. doi: 10.1007/s00192-013-2273-x. Epub 2013 Dec 12.
• Santoro GA, Wieczorek AP, Dietz HP, Mellgren A, Sultan AH, Shobeiri SA, Stankiewicz A, Bartram C. State of the art: an integrated approach to pelvic floor ultrasonography. Ultrasound Obstet Gynecol. 2011 Apr;37(4):381-96. doi: 10.1002/uog.8816.
• Shobeiri SA, Nolan TE, Yordan-Jovet R, Echols KT, Chesson RR. Digital examination compared to trans-perineal ultrasound for the evaluation of anal sphincter repair. Int J Gynaecol Obstet. 2002 Jul;78(1):31-6. doi: 10.1016/s0020-7292(02)00068-1.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): January 31, 2016
• Study Completion (Actual): January 19, 2017

Study Registration Dates

• First Submitted: January 30, 2017
• First Submitted That Met QC Criteria: January 30, 2017
• First Posted (Estimate): February 1, 2017

Study Record Updates

• Last Update Posted (Actual): February 13, 2017
• Last Update Submitted That Met QC Criteria: February 10, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: perineal tear; bidigital palpation; perineal ultrasound; post partum diagnostics
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: OstergotlandCC2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No