xml: <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/NCT06009562</url>
    </required_header>
    <id_info>
      <org_study_id>LPTM-S-UFs-Pregancy</org_study_id>
      <nct_id>NCT06009562</nct_id>
    </id_info>
    <brief_title>Management of Symptomatic Uterine Fibroids in Pregnancy by Laparotomic Myomectomy: a Prospective Cohort Study</brief_title>
    <acronym>LPTM-UFs-P</acronym>
    <official_title>Management of Symptomatic Uterine Fibroids in Pregnancy by Laparotomic Myomectomy: a Prospective Cohort Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Palermo</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Palermo</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>
        The frequency of women presenting with a combination of uterine fibroids and pregnancy is&#xD;
        in-creasing nowadays. Uterine fibroids in pregnancy are an unfavorable condition in&#xD;
        themselves and being reactive to hormonal stimuli, tending to grow, can generate symptoms of&#xD;
        different lev-els of severity. Obstetrics and gynecologists are increasingly faced with the&#xD;
        problem of clarifying the management tactics of pregnant patients with symptomatic fibroids,&#xD;
        who may see their preg-nancy put at risk by these masses.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 19, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 19, 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>5 Months</target_duration>
    <primary_outcome>
      <measure>continuation of pregnancy</measure>
      <time_frame>5 months</time_frame>
      <description>Pregnancy continuation after surgery.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Fetal outcome</measure>
      <time_frame>5 months</time_frame>
      <description>Assessed by APGAR 1 and 5 min, birth weight, and fetal conformation.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">28</enrollment>
    <condition>Uterine Fibroid</condition>
    <condition>Pregnancy Related</condition>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Laparotomic myomectomy during pregnancy</intervention_name>
      <description>Surgical removal of symptomatic uterine fibroids in pregnancy by laparotomic access</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          pregnant women with symptomatic uterine fibroids (UFs)&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The large and giant size of UFs, which prevent the proper continuation of pregnancy&#xD;
               and/or occupy the entire small and large pelvis, as well as invade and/or occupy the&#xD;
               abdominal cavity.&#xD;
  &#xD;
            -  Circulatory disorders, evidenced by necrosis of the UFs.&#xD;
  &#xD;
            -  Atypical localization of UFs (cervical, isthmic, intraligamentary, etc.), which caused&#xD;
               pelvic organ dysfunction (dysuric phenomena, tenesmus, impediment to the act of&#xD;
               defecation, pelvic pain).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Refusal of LPTM by the patient.&#xD;
  &#xD;
            -  Absence of urgent indication for LPTM during pregnancy.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Andrea Etrusco, M.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Palermo</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Antonio Simone Laganà, M.D. Ph.D.</last_name>
      <role>Study Director</role>
      <affiliation>University of Palermo</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Andrea Etrusco, M.D.</last_name>
      <phone>3881614022</phone>
      <email>etruscoandrea@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>State-Funded Health Care Facility of Moscow Region (GBUZ MO MONIIAG)</name>
        <address>
          <city>Moscow</city>
          <zip>101000</zip>
          <country>Russian Federation</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Andrea Etrusco, M.D.</last_name>
        <phone>+39 388 1614022</phone>
        <email>etruscoandrea@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Russian Federation</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 19, 2023</last_update_submitted>
    <last_update_submitted_qc>August 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Palermo</investigator_affiliation>
      <investigator_full_name>Andrea Etrusco</investigator_full_name>
      <investigator_title>M.D.</investigator_title>
    </responsible_party>
    <keyword>Uterine fibroids</keyword>
    <keyword>Pregnancy</keyword>
    <keyword>myomectomy</keyword>
    <keyword>fetal outcomes</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Leiomyoma</mesh_term>
      <mesh_term>Myofibroma</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06009562
  org study id: LPTM-S-UFs-Pregancy
  nct id: NCT06009562
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The frequency of women presenting with a combination of uterine fibroids and pregnancy is
        in-creasing nowadays. Uterine fibroids in pregnancy are an unfavorable condition in
        themselves and being reactive to hormonal stimuli, tending to grow, can generate symptoms of
        different lev-els of severity. Obstetrics and gynecologists are increasingly faced with the
        problem of clarifying the management tactics of pregnant patients with symptomatic fibroids,
        who may see their preg-nancy put at risk by these masses.
  observational model: Cohort
  time perspective: Prospective
  measure: continuation of pregnancy
  time frame: 5 months
  description: Pregnancy continuation after surgery.
  measure: Fetal outcome
  time frame: 5 months
  description: Assessed by APGAR 1 and 5 min, birth weight, and fetal conformation.
  intervention type: Procedure
  intervention name: Laparotomic myomectomy during pregnancy
  description: Surgical removal of symptomatic uterine fibroids in pregnancy by laparotomic access
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Andrea Etrusco, M.D.
  role: Principal Investigator
  affiliation: University of Palermo
  last name: Antonio Simone Laganà, M.D. Ph.D.
  role: Study Director
  affiliation: University of Palermo
  last name: Andrea Etrusco, M.D.
  phone: 3881614022
  email: etruscoandrea@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Russian Federation
  responsible party type: Principal Investigator
  investigator affiliation: University of Palermo
  investigator full name: Andrea Etrusco
  investigator title: M.D.
  mesh term: Leiomyoma
  mesh term: Myofibroma