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CompletedNCT03039582AVD and OASRUpdated Feb 13, 2017

Short Anovaginal Distance is Associated With Obstetric Anal Sphincter Rupture

An observational study in Perineal Tear and Obstetric Trauma, sponsored by Ostergotland County Council, Sweden. Completed. Open to female participants. Per ClinicalTrials.gov, last updated 2017-02-13.

Sponsored by Ostergotland County Council, Sweden · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
151
Sex
Female
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Study summary

Anovaginal distance measured by palpation and perineal ultrasound are similar.

Read the 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.

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Conditions studied

  • Perineal Tear
  • Obstetric Trauma

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Keywords

  • perineal tear
  • bidigital palpation
  • perineal ultrasound
  • post partum diagnostics
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In context

Rupture

557 studies on the registry are indexed under Rupture; 97 are open to participants now.

This study's enrollment of 151 is above the median of 100 across 203 observational studies indexed under Rupture.

Browse Rupture studies →

Lead sponsor

Ostergotland County Council, Sweden is the lead sponsor of 17 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Women just after vaginal delivery

Eligibility criteria

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 design

Observational model
Case-only
Time perspective
Prospective
Enrollment
151 participants (actual)
Patient registry
No

Groups and cohorts

  • Probable grad 2

    Perineal laceration Probable grad 2

    Diagnostic Test: Bidigital palpation · Diagnostic Test: Perineal ultrasound

  • Suspected grade 3

    Perineal laceration Suspected grade 3

    Diagnostic Test: Bidigital palpation · Diagnostic Test: Perineal ultrasound

  • Probable grad 3

    Perineal laceration Probable grad 3

    Diagnostic Test: Bidigital palpation · Diagnostic Test: Perineal ultrasound

Interventions

  • Diagnostic testBidigital palpation

    palpation of the anovaginal distance with two fingers

  • Diagnostic testPerineal ultrasound

    ultrasound measurement of the anovaginal distance

    Also known as: Vaginal ultrasound, transperineal ultrasound

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What researchers measure

Primary outcomes

  1. Correlation between palpated and ultrasound- measured anovaginal distance

    Does palpation give a reliable result?

    Time frame: immediate

Secondary outcomes

  1. Anal Sphincter rupture incidence

    How common is anal sphincter rupture

    Time frame: immediate

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Study locations

No study locations are listed for this record.

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References and documents

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. doi: 10.1016/j.jogc.2016.02.004. PubMed 26637088 ↗
  • 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. PubMed 24337585 ↗
  • 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. PubMed 20814874 ↗
  • 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. PubMed 12113968 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03039582
Lead sponsor
Ostergotland County Council, Sweden
Responsible party
Eva Uustal (Senior consultant, Ostergotland County Council, Sweden) — Principal investigator
First posted
Feb 1, 2017
Start date
Sep 1, 2014
Primary completion
Jan 31, 2016
Completion
Jan 19, 2017
Last update
Feb 13, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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