Clinical trial NCT03039582: Short Anovaginal Distance is Associated With Obstetric Anal Sphincter Rupture
Official title: Short Anovaginal Distance is Associated With Obstetric Anal Sphincter Rupture
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perineal Tear
Obstetric Trauma
Keywords: perineal tear
bidigital palpation
perineal ultrasound
post partum diagnostics
Lead sponsor: Ostergotland County Council, Sweden
Sponsor class: OTHER
First posted: 2017-02-01
Enrollment: 151
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women just after vaginal delivery

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.

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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Primary outcomes:
measure: Correlation between palpated and ultrasound- measured anovaginal distance
timeFrame: immediate
Secondary outcomes:
measure: Anal Sphincter rupture incidence
timeFrame: immediate
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.