<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/NCT01731288</url>
  </required_header>
  <id_info>
    <org_study_id>H11-00968</org_study_id>
    <nct_id>NCT01731288</nct_id>
  </id_info>
  <brief_title>Pregnancy, Childbirth Intentions and Outcomes Under Sexual Pain</brief_title>
  <acronym>PRECIOUS</acronym>
  <official_title>Pregnancy, Childbirth Intentions and Outcomes Under Sexual Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is to assess conception, pregnancy, childbirth, and pain&#xD;
      experiences among women who have been diagnosed with vulvodynia. Specifically, this study&#xD;
      aims to examine the following among women who have been diagnosed with vulvodynia: 1) rates&#xD;
      of pregnancy/childbirth and desire for children; 2) fear of pregnancy and childbirth; 3)&#xD;
      potential difficulties experienced while attempting to become pregnant and during&#xD;
      pregnancy/childbirth; 4) methods used to become pregnant and deliver; 5) methods used to&#xD;
      manage vulvodynia symptoms during pregnancy; and 6) pain outcomes associated with pregnancy.&#xD;
&#xD;
      Very little research has examined pregnancy/childbirth experiences among women with&#xD;
      vulvodynia, or the natural history of vulvodynia. As such this is a preliminary investigation&#xD;
      that will provide descriptive information regarding many of the proposed research questions.&#xD;
      Based on the clinical experience of the investigators, it is expected that women with&#xD;
      vulvodynia will report lower rates of pregnancy and higher levels of fear about pregnancy and&#xD;
      childbirth in comparison to women without such pain. It is also expected that women with&#xD;
      vulvodynia will report more difficulties becoming pregnant as compared to women without such&#xD;
      pain, and that women with vulvodynia will report more elective nonvaginal births in&#xD;
      comparison to vaginal births.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pregnancy Rates</measure>
    <time_frame>data is collected at a single time point</time_frame>
    <description>We will assess if women with vulvodynia experience different rates of pregnancy in comparison to women without such pain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intentions to have children</measure>
    <time_frame>data is collected at a single time point</time_frame>
    <description>We will assess how many women with vulvodynia wish to have children in their lifetime.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fear of pregnancy/childbirth</measure>
    <time_frame>data is collected at a single time point</time_frame>
    <description>We will assess if women with vulvodynia report higher levels of fear about pregnancy and childbirth in comparison to women without such pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Difficulties becoming pregnant</measure>
    <time_frame>data is collected at a single time point</time_frame>
    <description>We will assess if women with vulvodynia experience more difficulties becoming pregnant in comparison to women without such pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pregnancy/delivery complications</measure>
    <time_frame>data is collected at a single time point.</time_frame>
    <description>We will assess if women with vulvodynia experience more complications during pregnancy and delivery in comparison to women without such pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pregnancy/delivery methods</measure>
    <time_frame>data is collected at a single time point</time_frame>
    <description>We will assess what methods women with vulvodynia use to become pregnant and deliver.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Symptom management during pregnancy</measure>
    <time_frame>data is collected at a single time point</time_frame>
    <description>We will assess how women manage their vulvodynia symptoms during pregnancy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of pain symptoms during and after pregnancy</measure>
    <time_frame>data is collected at a single time point</time_frame>
    <description>We will assess if vulvodynia-related pain symptoms change during and after pregnancy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Course of vulvodynia</measure>
    <time_frame>data is collected at a single time point</time_frame>
    <description>We will assess the course of vulvodynia after treatment is received from health care workers specializing in vulvar pain.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">241</enrollment>
  <condition>Vulvodynia</condition>
  <condition>Provoked Vestibulodynia</condition>
  <arm_group>
    <arm_group_label>vulvodynia</arm_group_label>
    <description>Women with vulvodynia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <description>Women without vulvar pain</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The control group consists of a community sample. The vulvodynia group consists of women&#xD;
        who have been diagnosed with vulvodynia/provoked vestibulodynia and who have been assessed&#xD;
        and/or treated at 1 of 3 tertiary clinics:&#xD;
&#xD;
        1) Vulvar Pain Clinic (no longer active) located at the Women's Clinic, Willow Pavilion,&#xD;
        Vancouver General Hospital; 2) Multidisciplinary Vulvodynia Program (MVP); or 3) BC Centre&#xD;
        for Sexual Medicine&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  previous diagnosis of vulvodynia from a physician (women with vulvodynia only)&#xD;
&#xD;
          -  assessed and/or treated at one of 3 clinics (women with vulvodynia only)&#xD;
&#xD;
          -  free from chronic vulvar pain and pain with sexual intercourse in their lifetime&#xD;
             (control women only)&#xD;
&#xD;
          -  19 years of age or older&#xD;
&#xD;
          -  fluent in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  younger than 19 years of age&#xD;
&#xD;
          -  lack of fluency in English&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lori A Brotto, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Diamond Health Care Centre, Vancouver Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 1M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>http://www.obgyn.ubc.ca/SexualHealth/</url>
    <description>University of British Columbia Sexual Health Lab website</description>
  </link>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>November 15, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>May 30, 2017</last_update_submitted>
  <last_update_submitted_qc>May 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Lori Brotto</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>pregnancy</keyword>
  <keyword>childbirth</keyword>
  <keyword>pain</keyword>
  <keyword>vulvodynia</keyword>
  <keyword>provoked vestibulodynia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vulvodynia</mesh_term>
    <mesh_term>Vulvar Vestibulitis</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/NCT01731288
org study id: H11-00968
nct id: NCT01731288
lead sponsor: 
has dmc: No
The main purpose of this study is to assess conception, pregnancy, childbirth, and pain
      experiences among women who have been diagnosed with vulvodynia. Specifically, this study
      aims to examine the following among women who have been diagnosed with vulvodynia: 1) rates
      of pregnancy/childbirth and desire for children; 2) fear of pregnancy and childbirth; 3)
      potential difficulties experienced while attempting to become pregnant and during
      pregnancy/childbirth; 4) methods used to become pregnant and deliver; 5) methods used to
      manage vulvodynia symptoms during pregnancy; and 6) pain outcomes associated with pregnancy.

      Very little research has examined pregnancy/childbirth experiences among women with
      vulvodynia, or the natural history of vulvodynia. As such this is a preliminary investigation
      that will provide descriptive information regarding many of the proposed research questions.
      Based on the clinical experience of the investigators, it is expected that women with
      vulvodynia will report lower rates of pregnancy and higher levels of fear about pregnancy and
      childbirth in comparison to women without such pain. It is also expected that women with
      vulvodynia will report more difficulties becoming pregnant as compared to women without such
      pain, and that women with vulvodynia will report more elective nonvaginal births in
      comparison to vaginal births.
observational model: Other
time perspective: Retrospective
measure: Pregnancy Rates
time frame: data is collected at a single time point
description: We will assess if women with vulvodynia experience different rates of pregnancy in comparison to women without such pain
measure: Intentions to have children
time frame: data is collected at a single time point
description: We will assess how many women with vulvodynia wish to have children in their lifetime.
measure: Fear of pregnancy/childbirth
time frame: data is collected at a single time point
description: We will assess if women with vulvodynia report higher levels of fear about pregnancy and childbirth in comparison to women without such pain.
measure: Difficulties becoming pregnant
time frame: data is collected at a single time point
description: We will assess if women with vulvodynia experience more difficulties becoming pregnant in comparison to women without such pain.
measure: Pregnancy/delivery complications
time frame: data is collected at a single time point.
description: We will assess if women with vulvodynia experience more complications during pregnancy and delivery in comparison to women without such pain.
measure: Pregnancy/delivery methods
time frame: data is collected at a single time point
description: We will assess what methods women with vulvodynia use to become pregnant and deliver.
measure: Symptom management during pregnancy
time frame: data is collected at a single time point
description: We will assess how women manage their vulvodynia symptoms during pregnancy.
measure: Change of pain symptoms during and after pregnancy
time frame: data is collected at a single time point
description: We will assess if vulvodynia-related pain symptoms change during and after pregnancy.
measure: Course of vulvodynia
time frame: data is collected at a single time point
description: We will assess the course of vulvodynia after treatment is received from health care workers specializing in vulvar pain.
arm group label: vulvodynia
description: Women with vulvodynia
arm group label: control
description: Women without vulvar pain
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 19 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Lori A Brotto, PhD
role: Principal Investigator
affiliation: University of British Columbia
facility: 
country: Canada
url: http://www.obgyn.ubc.ca/SexualHealth/
description: University of British Columbia Sexual Health Lab website
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Lori Brotto
investigator title: Principal Investigator
mesh term: Vulvodynia
mesh term: Vulvar Vestibulitis