Short Anovaginal Distance is Associated With Obstetric Anal Sphincter Rupture

Perineal Tear Clinical Trial

— AVD and OASR  

Official title:

Short Anovaginal Distance is Associated With Obstetric Anal Sphincter Rupture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03039582
• Other study ID #: OstergotlandCC2
• Status: Completed
• Phase: N/A
• First received: January 30, 2017
• Last updated: February 10, 2017
• Start date: September 1, 2014
• Est. completion date: January 19, 2017

Study information

• Verified date: February 2017
• Source: Ostergotland County Council, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Anovaginal distance measured by palpation and perineal ultrasound are similar.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: January 19, 2017
• Est. primary completion date: January 31, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Obstetric Trauma
• Perineal Tear
• Rupture

Intervention

Diagnostic Test:
• Bidigital palpation
palpation of the anovaginal distance with two fingers
• Perineal ultrasound
ultrasound measurement of the anovaginal distance

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ostergotland County Council, Sweden

References & Publications (4)

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. — View 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. Erratum in: J Obstet Gynaecol Can. 2016 Apr;38(4):421. J Obstet Gynaecol Can. 2016 Apr;38(4):421. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between palpated and ultrasound- measured anovaginal distance	Does palpation give a reliable result?	immediate
Secondary	Anal Sphincter rupture incidence	How common is anal sphincter rupture	immediate