<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/NCT03028623</url>
  </required_header>
  <id_info>
    <org_study_id>19517</org_study_id>
    <nct_id>NCT03028623</nct_id>
  </id_info>
  <brief_title>Standard Tubal Ligation Versus Salpingectomy for Sterilization at the Time of Cesarean Delivery</brief_title>
  <official_title>A Randomized Controlled Trial of Standard Tubal Ligation Versus Salpingectomy for Sterilization at the Time of Cesarean Delivery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Virginia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Virginia</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 objective of this study is to evaluate the feasibility and safety of salpingectomy versus&#xD;
      standard tubal ligation in women undergoing surgical sterilization at the time of a planned&#xD;
      cesarean delivery. Salpingectomy is currently being investigated as a potential strategy for&#xD;
      ovarian cancer prevention. While this procedure is currently performed during hysterectomies,&#xD;
      its feasibility at the time of cesarean delivery is not well established.&#xD;
&#xD;
      This randomized, prospective clinical trial will compare the two sterilization methods to&#xD;
      demonstrate that salpingectomy compared with standard tubal ligation at the time of cesarean&#xD;
      delivery will not result in increased operative time, blood loss or other complications. This&#xD;
      study is necessary to promote salpingectomy as a standard sterilization method during&#xD;
      cesarean deliveries.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Actual">March 5, 2018</completion_date>
  <primary_completion_date type="Actual">March 5, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time of tubal ligation</measure>
    <time_frame>at time of procedure</time_frame>
    <description>Primary outcome will be the time it takes to complete the sterilization procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total procedure time</measure>
    <time_frame>at time of procedure</time_frame>
    <description>The total time it takes to complete the cesarean plus sterilization procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimated blood loss</measure>
    <time_frame>at time of procedure</time_frame>
    <description>Estimated blood loss for the entire procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of aborted procedures</measure>
    <time_frame>at time of procedure</time_frame>
    <description>Inability to complete bilateral salpingectomy in the experimental arm</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Reoperation rate</measure>
    <time_frame>within 6 weeks</time_frame>
    <description>Rate of reoperation within 6 weeks</description>
  </other_outcome>
  <other_outcome>
    <measure>Length of stay</measure>
    <time_frame>within 1008 hours</time_frame>
    <description>Length of stay in hours</description>
  </other_outcome>
  <other_outcome>
    <measure>Readmission rate</measure>
    <time_frame>within 6 weeks</time_frame>
    <description>Rate of readmission within 6 weeks</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Method of Tubal Ligation at the Time of Cesarean Section</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Tubal sterilization will be performed by standard tubal ligation, either Parkland or Pomeroy technique, at the time of cesarean section</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tubal sterilization will be performed by bilateral salpingectomy using a ligasure device at the time of cesarean section.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Salpingectomy</intervention_name>
    <description>Bilateral salpingectomy will be performed instead of standard tubal ligation as sterilization during cesarean section.</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Tubal ligation</intervention_name>
    <description>Standard tubal ligation by either Parkland or Pomeroy technique will be performed at cesarean section</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must have planned cesarean delivery and desire sterilization&#xD;
&#xD;
          -  Subjects must be able to read and provide written informed consent&#xD;
&#xD;
          -  Subjects must be English or Spanish speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with known hereditary cancer syndromes&#xD;
&#xD;
          -  Subjects with a history of prior tubal surgery&#xD;
&#xD;
          -  Subjects with a placenta accreta&#xD;
&#xD;
          -  Subjects undergoing trial of labor after cesarean delivery&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kate' Pettit, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Virginia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>April 7, 2018</last_update_submitted>
  <last_update_submitted_qc>April 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Virginia</investigator_affiliation>
    <investigator_full_name>Kate Pettit, MD</investigator_full_name>
    <investigator_title>Assistant Professor, Division of Maternal Fetal Medicine</investigator_title>
  </responsible_party>
  <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/NCT03028623
org study id: 19517
nct id: NCT03028623
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to evaluate the feasibility and safety of salpingectomy versus
      standard tubal ligation in women undergoing surgical sterilization at the time of a planned
      cesarean delivery. Salpingectomy is currently being investigated as a potential strategy for
      ovarian cancer prevention. While this procedure is currently performed during hysterectomies,
      its feasibility at the time of cesarean delivery is not well established.

      This randomized, prospective clinical trial will compare the two sterilization methods to
      demonstrate that salpingectomy compared with standard tubal ligation at the time of cesarean
      delivery will not result in increased operative time, blood loss or other complications. This
      study is necessary to promote salpingectomy as a standard sterilization method during
      cesarean deliveries.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Time of tubal ligation
time frame: at time of procedure
description: Primary outcome will be the time it takes to complete the sterilization procedure
measure: Total procedure time
time frame: at time of procedure
description: The total time it takes to complete the cesarean plus sterilization procedure
measure: Estimated blood loss
time frame: at time of procedure
description: Estimated blood loss for the entire procedure
measure: Rate of aborted procedures
time frame: at time of procedure
description: Inability to complete bilateral salpingectomy in the experimental arm
measure: Reoperation rate
time frame: within 6 weeks
description: Rate of reoperation within 6 weeks
measure: Length of stay
time frame: within 1008 hours
description: Length of stay in hours
measure: Readmission rate
time frame: within 6 weeks
description: Rate of readmission within 6 weeks
arm group label: Control
arm group type: Other
description: Tubal sterilization will be performed by standard tubal ligation, either Parkland or Pomeroy technique, at the time of cesarean section
arm group label: Experimental
arm group type: Experimental
description: Tubal sterilization will be performed by bilateral salpingectomy using a ligasure device at the time of cesarean section.
intervention type: Procedure
intervention name: Salpingectomy
description: Bilateral salpingectomy will be performed instead of standard tubal ligation as sterilization during cesarean section.
arm group label: Experimental
intervention type: Procedure
intervention name: Tubal ligation
description: Standard tubal ligation by either Parkland or Pomeroy technique will be performed at cesarean section
arm group label: Control
criteria: 
gender: Female
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kate' Pettit, MD
role: Principal Investigator
affiliation: University of Virginia
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Virginia
investigator full name: Kate Pettit, MD
investigator title: Assistant Professor, Division of Maternal Fetal Medicine
sharing ipd: No