<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/NCT01680731</url>
  </required_header>
  <id_info>
    <org_study_id>39146</org_study_id>
    <nct_id>NCT01680731</nct_id>
  </id_info>
  <brief_title>3D Ultrasound in Women With Vacuum or Forceps Deliveries</brief_title>
  <acronym>VADUS</acronym>
  <official_title>3-Dimension Ultrasound Findings in Women Who Have Undergone Vacuum Versus Forceps-Assisted Vaginal Deliveries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Rochester</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate of the differences in pelvic floor anatomy and&#xD;
      function in women who have undergone a vacuum assisted vaginal delivery (VAVD) versus a&#xD;
      forceps assisted vaginal delivery (FAVD) using three-dimensional ultrasound imaging. Women&#xD;
      within 1-5 years after first delivery who did not have an internal delivery will be included.&#xD;
      The total number of subjects is forty. This will include ten primiparous subjects who have&#xD;
      undergone vacuum delivery, ten who have undergone forceps delivery, ten who had spontaneous&#xD;
      vaginal delivery and ten who have undergone primary elective cesarean section.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2011</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Levator ani injury on 3D ultrasound</measure>
    <time_frame>1-5 years after delivery</time_frame>
    <description>Assessment of levator ani injury on trasnperineal 3D ultrasound images</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">45</enrollment>
  <condition>Pelvic Floor Injury</condition>
  <condition>Urinary Incontinence</condition>
  <condition>Stool Incontinence</condition>
  <arm_group>
    <arm_group_label>Forceps assisted vaginal delivery</arm_group_label>
    <description>Forceps assisted vaginal delivery within 1-5 years without any interval delivery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vacuum assisted vaginal delivery</arm_group_label>
    <description>Vacuum assisted vaginal delivery within 1-5 years without any interval delivery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Elective cesarean delivery</arm_group_label>
    <description>Elective cesarean vaginal delivery within 1-5 years without any interval delivery done prior to labor</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Spontaneous vaginal delivery</arm_group_label>
    <description>Spontaneous vaginal delivery within 1-5 years without any interval delivery</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Forty primiparous subjects with a history of a singleton pregnancy who have undergone a&#xD;
        term vacuum assisted vaginal delivery, forceps assisted vaginal delivery, spontaneous&#xD;
        vaginal delivery, or elective primary cesarean section or spontaneous vaginal delivery with&#xD;
        10 subjects in each group.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Females age &gt;18 and &lt;45.&#xD;
&#xD;
          -  Primiparous females with singleton pregnancy who have undergone a term vacuum assisted&#xD;
             vaginal delivery, forceps assisted vaginal delivery, spontaneous vaginal delivery, or&#xD;
             elective primary cesarean section or spontaneous vaginal delivery.&#xD;
&#xD;
          -  Birth weight &gt;2500g and &lt;4500g.&#xD;
&#xD;
          -  Delivery should have occurred more than one year ago, but less than five years ago.&#xD;
&#xD;
        Pregestational BMI &lt;35kg40kg/m2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of interim delivery.&#xD;
&#xD;
          -  Presence of both vacuum and forceps use during delivery.&#xD;
&#xD;
          -  Presence of pregestational or A2 gestational diabetes mellitus.&#xD;
&#xD;
          -  Presence of neuromuscular disorder (i.e., spinal cord disease, Multiple Sclerosis,&#xD;
             Myasthenia Gravis) or connective tissue disorder (i.e., Lupus and Sjogren's disease).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tulin Ozcan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Rochester</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Rochester</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2014</verification_date>
  <study_first_submitted>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>February 19, 2014</last_update_submitted>
  <last_update_submitted_qc>February 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 21, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Rochester</investigator_affiliation>
    <investigator_full_name>Tulin Ozcan MD</investigator_full_name>
    <investigator_title>Associate Professor of Obstetrics and Gynecology</investigator_title>
  </responsible_party>
  <keyword>Pelvic floor injury</keyword>
  <keyword>Levator ani muscle</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Incontinence</mesh_term>
  </condition_browse>
  <!-- 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/NCT01680731
org study id: 39146
nct id: NCT01680731
lead sponsor: 
has dmc: No
The purpose of this study is to investigate of the differences in pelvic floor anatomy and
      function in women who have undergone a vacuum assisted vaginal delivery (VAVD) versus a
      forceps assisted vaginal delivery (FAVD) using three-dimensional ultrasound imaging. Women
      within 1-5 years after first delivery who did not have an internal delivery will be included.
      The total number of subjects is forty. This will include ten primiparous subjects who have
      undergone vacuum delivery, ten who have undergone forceps delivery, ten who had spontaneous
      vaginal delivery and ten who have undergone primary elective cesarean section.
observational model: Case-Control
time perspective: Retrospective
measure: Levator ani injury on 3D ultrasound
time frame: 1-5 years after delivery
description: Assessment of levator ani injury on trasnperineal 3D ultrasound images
arm group label: Forceps assisted vaginal delivery
description: Forceps assisted vaginal delivery within 1-5 years without any interval delivery
arm group label: Vacuum assisted vaginal delivery
description: Vacuum assisted vaginal delivery within 1-5 years without any interval delivery
arm group label: Elective cesarean delivery
description: Elective cesarean vaginal delivery within 1-5 years without any interval delivery done prior to labor
arm group label: Spontaneous vaginal delivery
description: Spontaneous vaginal delivery within 1-5 years without any interval delivery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Tulin Ozcan, MD
role: Principal Investigator
affiliation: University of Rochester
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Rochester
investigator full name: Tulin Ozcan MD
investigator title: Associate Professor of Obstetrics and Gynecology
mesh term: Urinary Incontinence