<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/NCT03270605</url>
  </required_header>
  <id_info>
    <org_study_id>R/17.04.71</org_study_id>
    <nct_id>NCT03270605</nct_id>
  </id_info>
  <brief_title>Myomectomy During CS: A Retrospective Cohort Study</brief_title>
  <official_title>Myomectomy During Cesarean Section: A Retrospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the value of myomectomy during delivery by cesarean section (CS) in pregnant&#xD;
      women with uterine fibroids.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2015</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</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>Deficit in hemoglobin level</measure>
    <time_frame>24 hours</time_frame>
    <description>Preoperative hemoglobin minus postoperative hemoglobin level (in gm/dl)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Operative time</measure>
    <time_frame>3 hours</time_frame>
    <description>Time to complete the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative hospital stay period</measure>
    <time_frame>7 days</time_frame>
    <description>Time from the end of operation to discharge from hospital</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">178</enrollment>
  <condition>Cesarean Section</condition>
  <condition>Uterine Fibroid</condition>
  <arm_group>
    <arm_group_label>CS with myomectomy</arm_group_label>
    <description>Women having uterine myoma with pregnancy and subjected to myomectomy during delivery by CS</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CS without myomectomy</arm_group_label>
    <description>Women having uterine myoma with pregnancy and delivered by CS without myomectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Myomectomy</intervention_name>
    <description>Surgical removal of uterine fibroid</description>
    <arm_group_label>CS with myomectomy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women with uterine fibroid during the index pregnancy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women who underwent elective CS with presence of uterine fibroid during the index&#xD;
             pregnancy documented antenatal and at surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Antepartum hemorrhage&#xD;
&#xD;
          -  Blood diseases or bleeding tendencies.&#xD;
&#xD;
          -  Medical conditions complicating pregnancy.&#xD;
&#xD;
          -  Performed another surgical procedure at CS other than myomectomy.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>41 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Waleed El-refaie, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Port Said University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohamed Hassan, MD</last_name>
    <role>Study Director</role>
    <affiliation>Mansoura University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohamed S Abdelhafez, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Mansoura University</affiliation>
  </overall_official>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>August 28, 2020</last_update_submitted>
  <last_update_submitted_qc>August 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leiomyoma</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/NCT03270605
org study id: R/17.04.71
nct id: NCT03270605
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To evaluate the value of myomectomy during delivery by cesarean section (CS) in pregnant
      women with uterine fibroids.
observational model: Cohort
time perspective: Retrospective
measure: Deficit in hemoglobin level
time frame: 24 hours
description: Preoperative hemoglobin minus postoperative hemoglobin level (in gm/dl)
measure: Operative time
time frame: 3 hours
description: Time to complete the procedure
measure: Postoperative hospital stay period
time frame: 7 days
description: Time from the end of operation to discharge from hospital
arm group label: CS with myomectomy
description: Women having uterine myoma with pregnancy and subjected to myomectomy during delivery by CS
arm group label: CS without myomectomy
description: Women having uterine myoma with pregnancy and delivered by CS without myomectomy
intervention type: Procedure
intervention name: Myomectomy
description: Surgical removal of uterine fibroid
arm group label: CS with myomectomy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 41 Years
healthy volunteers: No
last name: Waleed El-refaie, MD
role: Principal Investigator
affiliation: Port Said University
last name: Mohamed Hassan, MD
role: Study Director
affiliation: Mansoura University
last name: Mohamed S Abdelhafez, MD
role: Study Chair
affiliation: Mansoura University
responsible party type: Sponsor
mesh term: Leiomyoma
sharing ipd: Undecided