<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03039582</url>
  </required_header>
  <id_info>
    <org_study_id>OstergotlandCC2</org_study_id>
    <nct_id>NCT03039582</nct_id>
  </id_info>
  <brief_title>Short Anovaginal Distance is Associated With Obstetric Anal Sphincter Rupture</brief_title>
  <acronym>AVD and OASR</acronym>
  <official_title>Short Anovaginal Distance is Associated With Obstetric Anal Sphincter Rupture</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ostergotland County Council, Sweden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ostergotland County Council, Sweden</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Anovaginal distance measured by palpation and perineal ultrasound are similar.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Objective diagnostic methods for obstetric anal sphincter rupture, (OASR) such as&#xD;
      endoanalt ultrasound (EAUS), show missed ruptures that can lead to anal incontinence. To&#xD;
      perform EAUS after all deliveries at all hours, although it may lead to diagnostic&#xD;
      improvement is not feasible in most delivery wards. Another objective method for screening&#xD;
      women after delivery to identify OASR would be of value. Bidigital palpation of the perineum&#xD;
      is often suggested without specifying what results are relevant.&#xD;
&#xD;
      AIM:&#xD;
&#xD;
      The aim of this study was to establish if the palpated anovaginal distance after delivery&#xD;
      could be confirmed by perineal ultrasound and correlated to the extent of the perineal tear.&#xD;
&#xD;
      MATERIALS AND METHODS:&#xD;
&#xD;
      A structured educational programme for midwives (palpation) and doctors (perineal ultrasound)&#xD;
      was accomplished. Midwives were instructed to record the palpated anovaginal distance in&#xD;
      primiparae with spontaneous vaginal delivery and no episiotomy. If the AVD was found to be&#xD;
      shorter than 2 cm, she recorded a primary diagnosis of probable grade 2, suspected grade 3 or&#xD;
      probable grade 3 and called the doctor. The AVD was then measured by perineal ultrasound by a&#xD;
      doctor aware of a laceration but not it´s extent, which was then established by clinical exam&#xD;
      and perineal ultrasound.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2014</start_date>
  <completion_date type="Actual">January 19, 2017</completion_date>
  <primary_completion_date type="Actual">January 31, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation between palpated and ultrasound- measured anovaginal distance</measure>
    <time_frame>immediate</time_frame>
    <description>Does palpation give a reliable result?</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anal Sphincter rupture incidence</measure>
    <time_frame>immediate</time_frame>
    <description>How common is anal sphincter rupture</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">151</enrollment>
  <condition>Perineal Tear</condition>
  <condition>Obstetric Trauma</condition>
  <arm_group>
    <arm_group_label>Probable grad 2</arm_group_label>
    <description>Perineal laceration Probable grad 2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Suspected grade 3</arm_group_label>
    <description>Perineal laceration Suspected grade 3</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Probable grad 3</arm_group_label>
    <description>Perineal laceration Probable grad 3</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Bidigital palpation</intervention_name>
    <description>palpation of the anovaginal distance with two fingers</description>
    <arm_group_label>Probable grad 2</arm_group_label>
    <arm_group_label>Probable grad 3</arm_group_label>
    <arm_group_label>Suspected grade 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Perineal ultrasound</intervention_name>
    <description>ultrasound measurement of the anovaginal distance</description>
    <arm_group_label>Probable grad 2</arm_group_label>
    <arm_group_label>Probable grad 3</arm_group_label>
    <arm_group_label>Suspected grade 3</arm_group_label>
    <other_name>Vaginal ultrasound</other_name>
    <other_name>transperineal ultrasound</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women just after vaginal delivery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: women who just had their firstborn child through vaginal delivery at&#xD;
        the delivery ward at the University Hospital in Linköping, Sweden from October 2014 to&#xD;
        January 2016.&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria: inability to understand swedish&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <reference>
    <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. Erratum In: J Obstet Gynaecol Can. 2016 Apr;38(4):421. J Obstet Gynaecol Can. 2016 Apr;38(4):421.</citation>
    <PMID>26637088</PMID>
  </reference>
  <reference>
    <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>
    <PMID>24337585</PMID>
  </reference>
  <reference>
    <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>
    <PMID>20814874</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>12113968</PMID>
  </reference>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>January 30, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>February 10, 2017</last_update_submitted>
  <last_update_submitted_qc>February 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ostergotland County Council, Sweden</investigator_affiliation>
    <investigator_full_name>Eva Uustal</investigator_full_name>
    <investigator_title>Senior consultant</investigator_title>
  </responsible_party>
  <keyword>perineal tear</keyword>
  <keyword>bidigital palpation</keyword>
  <keyword>perineal ultrasound</keyword>
  <keyword>post partum diagnostics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rupture</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03039582
org study id: OstergotlandCC2
nct id: NCT03039582
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Anovaginal distance measured by palpation and perineal ultrasound are similar.
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.
observational model: Case-Only
time perspective: Prospective
measure: Correlation between palpated and ultrasound- measured anovaginal distance
time frame: immediate
description: Does palpation give a reliable result?
measure: Anal Sphincter rupture incidence
time frame: immediate
description: How common is anal sphincter rupture
arm group label: Probable grad 2
description: Perineal laceration Probable grad 2
arm group label: Suspected grade 3
description: Perineal laceration Suspected grade 3
arm group label: Probable grad 3
description: Perineal laceration Probable grad 3
intervention type: Diagnostic Test
intervention name: Bidigital palpation
description: palpation of the anovaginal distance with two fingers
arm group label: Probable grad 2
arm group label: Probable grad 3
arm group label: Suspected grade 3
intervention type: Diagnostic Test
intervention name: Perineal ultrasound
description: ultrasound measurement of the anovaginal distance
arm group label: Probable grad 2
arm group label: Probable grad 3
arm group label: Suspected grade 3
other name: Vaginal ultrasound
other name: transperineal ultrasound
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
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. Erratum In: J Obstet Gynaecol Can. 2016 Apr;38(4):421. J Obstet Gynaecol Can. 2016 Apr;38(4):421.
PMID: 26637088
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.
PMID: 24337585
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.
PMID: 20814874
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.
PMID: 12113968
responsible party type: Principal Investigator
investigator affiliation: Ostergotland County Council, Sweden
investigator full name: Eva Uustal
investigator title: Senior consultant
mesh term: Rupture
sharing ipd: No