<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/NCT04449640</url>
  </required_header>
  <id_info>
    <org_study_id>URAHSR-1</org_study_id>
    <nct_id>NCT04449640</nct_id>
  </id_info>
  <brief_title>Uterine Rupture After Hysteroscopic Septum Resection</brief_title>
  <official_title>Uterine Rupture in Pregnancy After Hysteroscopic Septum Resection: a Twenty-year Retrospective Analysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Università degli Studi dell'Insubria</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Ljubljana</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Università degli Studi di Brescia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Università degli Studi dell'Insubria</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>
      To date, several studies have already confirmed a positive effect of hysteroscopic&#xD;
      metroplasty on reproductive outcomes in primary infertile women affected by uterine septum,&#xD;
      the most common uterine malformation. Nevertheless, very few data are available about the&#xD;
      risk of uterine rupture in subsequent pregnancies after hysteroscopic septum resection (HSR).&#xD;
      In order to shed about this element, we will retrospectively review the cases of uterine&#xD;
      rupture in our setting in the last twenty years, identify which of them had previously&#xD;
      undergone HSR, and evaluate the main clinical characteristics for each case.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">April 1, 2021</completion_date>
  <primary_completion_date type="Actual">March 1, 2021</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Uterine rupture</measure>
    <time_frame>Retrospective analysis over the last twenty years.</time_frame>
    <description>Rupture of muscular wall of the uterus tears during pregnancy or childbirth.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">3000</enrollment>
  <condition>Septum; Uterus</condition>
  <condition>Rupture, Uterine</condition>
  <arm_group>
    <arm_group_label>Uterine rupture</arm_group_label>
    <description>Women who had uterine rupture during pregnancy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hysteroscopic septum resection.</intervention_name>
    <description>Resection of a uterine septum by hysteroscopic surgery.</description>
    <arm_group_label>Uterine rupture</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women who underwent previous hysteroscopic septum resection.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Previous hysteroscopic septum resection;&#xD;
&#xD;
          -  Pregnancy;&#xD;
&#xD;
          -  Uterine rupture.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous myomectomy (regardless of the surgical technique) or cesarean section.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>48 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Antonio Simone Laganà, M.D., Ph.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Università degli Studi dell'Insubria</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Helena Ban Frangež, M.D., Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>University of Ljubljana</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Antonio Simone Laganà</name>
      <address>
        <city>Ljubljana</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>April 28, 2021</last_update_submitted>
  <last_update_submitted_qc>April 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Università degli Studi dell'Insubria</investigator_affiliation>
    <investigator_full_name>Antonio Simone Laganà</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Hysteroscopy</keyword>
  <keyword>Uterine septum</keyword>
  <keyword>Complications</keyword>
  <keyword>Uterine perforation</keyword>
  <keyword>Pregnancy</keyword>
  <keyword>Uterine rupture</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Rupture</mesh_term>
    <mesh_term>Rupture</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04449640
org study id: URAHSR-1
nct id: NCT04449640
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To date, several studies have already confirmed a positive effect of hysteroscopic
      metroplasty on reproductive outcomes in primary infertile women affected by uterine septum,
      the most common uterine malformation. Nevertheless, very few data are available about the
      risk of uterine rupture in subsequent pregnancies after hysteroscopic septum resection (HSR).
      In order to shed about this element, we will retrospectively review the cases of uterine
      rupture in our setting in the last twenty years, identify which of them had previously
      undergone HSR, and evaluate the main clinical characteristics for each case.
observational model: Cohort
time perspective: Retrospective
measure: Uterine rupture
time frame: Retrospective analysis over the last twenty years.
description: Rupture of muscular wall of the uterus tears during pregnancy or childbirth.
arm group label: Uterine rupture
description: Women who had uterine rupture during pregnancy.
intervention type: Procedure
intervention name: Hysteroscopic septum resection.
description: Resection of a uterine septum by hysteroscopic surgery.
arm group label: Uterine rupture
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 48 Years
last name: Antonio Simone Laganà, M.D., Ph.D.
role: Study Chair
affiliation: Università degli Studi dell'Insubria
last name: Helena Ban Frangež, M.D., Ph.D.
role: Study Director
affiliation: University of Ljubljana
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Università degli Studi dell'Insubria
investigator full name: Antonio Simone Laganà
investigator title: Principal Investigator
mesh term: Uterine Rupture
mesh term: Rupture
sharing ipd: Undecided