<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/NCT03039374</url>
  </required_header>
  <id_info>
    <org_study_id>ISR-2014-10458</org_study_id>
    <nct_id>NCT03039374</nct_id>
  </id_info>
  <brief_title>External Phase MRI in Diagnosis of OASI</brief_title>
  <official_title>The Use of External Phase Array MRI, 3D Endoanal Ultrasound, and Manometry in the Diagnosis of Obstetric Anal Sphincter Injuries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Turku</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medtronic</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Turku</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is around 60 000 births annually in Finland. Around 1-5% of all vaginal deliveries in&#xD;
      Finland complicate in a Grade III- IV perineal tear. Because the diagnosis of a sphincter&#xD;
      lesion after birth can be challenging the total amount of women having obtained a sphincter&#xD;
      lesion could be even grater.&#xD;
&#xD;
      The aim of our study is to compare different tools in the diagnosis of obstetric anal&#xD;
      sphincter injury. In doing so the investigators hope to achieve early diagnosis of this&#xD;
      pathology and thus facilitate early treatment of a possible sphincter defect.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      See the attacher research plan for a more detailed description&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">October 27, 2017</completion_date>
  <primary_completion_date type="Actual">September 20, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of MRI and endoanal ultrasound in diagnosis of obstetric anal sphincter injury</measure>
    <time_frame>6 months to 1 year</time_frame>
    <description>Comparison of anal sphincter characteristics (length, thickness at 3 and 9 o'clock) and placement of the possible rupture with both imaging modalities</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">53</enrollment>
  <condition>Anal Sphincter Injury</condition>
  <condition>Obstetrics Trauma</condition>
  <arm_group>
    <arm_group_label>OASI patients</arm_group_label>
    <description>All patients older than 18 and a 3rd or 4th degree perineal tear during birth meet the inclusion criteria. All women who have obtained such a injury during birth in the Vaasa or Seinäjoki Central hospitals will be evaluated for eligibility.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Magnetic resonance imaging</intervention_name>
    <description>The extent of obstetric anal sphincter injury will be evaluated using MRI, endoanal ultrasound and anal manometry</description>
    <arm_group_label>OASI patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients older than 18 and a 3rd or 4th degree perineal tear observed during birth meet&#xD;
        the inclusion criteria. All women who have obtained such a injury during birth in the Vaasa&#xD;
        or Seinäjoki Central hospitals will be evaluated for eligibility.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Women with OASI&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Under 18&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mikael Victorzon, prof.</last_name>
    <role>Study Director</role>
    <affiliation>Professor of surgery Turku University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jaan Kirss, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Resident in Gastroenterological surgery</affiliation>
  </overall_official>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>November 30, 2016</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>October 31, 2017</last_update_submitted>
  <last_update_submitted_qc>October 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Turku</investigator_affiliation>
    <investigator_full_name>Jaan Kirss</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>OASI</keyword>
  <keyword>Faecal incontinence</keyword>
  <keyword>Obstetric anal sphincter injury</keyword>
  <keyword>MRI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</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/NCT03039374
org study id: ISR-2014-10458
nct id: NCT03039374
lead sponsor: 
collaborator: 
has dmc: No
There is around 60 000 births annually in Finland. Around 1-5% of all vaginal deliveries in
      Finland complicate in a Grade III- IV perineal tear. Because the diagnosis of a sphincter
      lesion after birth can be challenging the total amount of women having obtained a sphincter
      lesion could be even grater.

      The aim of our study is to compare different tools in the diagnosis of obstetric anal
      sphincter injury. In doing so the investigators hope to achieve early diagnosis of this
      pathology and thus facilitate early treatment of a possible sphincter defect.
See the attacher research plan for a more detailed description
observational model: Cohort
time perspective: Prospective
measure: Comparison of MRI and endoanal ultrasound in diagnosis of obstetric anal sphincter injury
time frame: 6 months to 1 year
description: Comparison of anal sphincter characteristics (length, thickness at 3 and 9 o'clock) and placement of the possible rupture with both imaging modalities
arm group label: OASI patients
description: All patients older than 18 and a 3rd or 4th degree perineal tear during birth meet the inclusion criteria. All women who have obtained such a injury during birth in the Vaasa or Seinäjoki Central hospitals will be evaluated for eligibility.
intervention type: Other
intervention name: Magnetic resonance imaging
description: The extent of obstetric anal sphincter injury will be evaluated using MRI, endoanal ultrasound and anal manometry
arm group label: OASI patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mikael Victorzon, prof.
role: Study Director
affiliation: Professor of surgery Turku University
last name: Jaan Kirss, MD
role: Principal Investigator
affiliation: Resident in Gastroenterological surgery
responsible party type: Principal Investigator
investigator affiliation: University of Turku
investigator full name: Jaan Kirss
investigator title: Principal Investigator
mesh term: Wounds and Injuries
sharing ipd: No