<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/NCT02219269</url>
  </required_header>
  <id_info>
    <org_study_id>140166</org_study_id>
    <nct_id>NCT02219269</nct_id>
  </id_info>
  <brief_title>A Complex Contraception Registry</brief_title>
  <official_title>A Complex Contraception Registry - UC Family Planning Collaborative Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, Irvine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Diego</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will conduct a prospective observational cohort study to investigate&#xD;
      factors that influence contraceptive method utilization among women with medical conditions.&#xD;
      The investigators will also investigate how women with medical conditions access to&#xD;
      contraception and family planning fellowship trained specialist. After the baseline&#xD;
      questionnaire, there be a 3 month and 6 month follow up questionnaire to investigate&#xD;
      continuation and satisfaction with the contraceptive method. This study is unique because it&#xD;
      will allow us to explore doing collaborative family planning research at the multiple UC&#xD;
      medical campuses.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Many women with complex medical conditions who do not desire pregnancy do not receive&#xD;
      contraception counseling from their primary or subspecialty care clinicians, and often they&#xD;
      are not using contraception. This is an important deficiency as many have conditions that&#xD;
      could worsen with pregnancy or for whom pregnancy can be complicated by the medical&#xD;
      condition. Thus it is important for women with chronic disease to only become pregnant if&#xD;
      they intend to do so. The United States Medical Eligibility Criteria for Contraceptive Use&#xD;
      (USMEC), released in 2010, has greatly enhanced the ability of clinicians to counsel patient&#xD;
      with complex medical conditions about their contraceptive options. It summarizes the safety&#xD;
      of specific contraceptives when used on women with medical conditions. However, little is&#xD;
      known about the contraceptive care of these women. We do not know if the availability of the&#xD;
      USMEC has translated into evidence-based contraceptive counseling for these women. Further,&#xD;
      little is known about their understanding of the interaction between their disease and&#xD;
      pregnancy, their past experience and knowledge about contraception, and their contraceptive&#xD;
      decision-making, satisfaction and continuation.&#xD;
&#xD;
      The purpose of the Complex Contraception Registry to is to recruit a cohort of women with&#xD;
      complex medical conditions who are seen in contraception referral practices run by family&#xD;
      planning fellowship trained physicians. We will assess their past experiences and baseline&#xD;
      knowledge, their post-counseling experiences and choice of contraception, and their long-term&#xD;
      satisfaction with and continuation of contraception. A multi-center registry is necessary&#xD;
      because individual institutions see relatively few women with rare diseases such as a history&#xD;
      of transplant surgery. The UC Family Planning Collaborative will facilitate recruitment of&#xD;
      participants from the 5 UC medical campuses and will oversee their follow-up for one year.&#xD;
&#xD;
      Specific Aim include (1.) To investigate what factors influence contraceptive method&#xD;
      utilization among women with complex medical conditions and their perceived risk of&#xD;
      unintended pregnancy (2) To investigate how women with complex medical conditions access&#xD;
      family planning fellowship trained specialist for contraception counseling and (3.) To assess&#xD;
      satisfaction and continuation of contraceptive methods among women with complex medical&#xD;
      conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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>6 Months</target_duration>
  <primary_outcome>
    <measure>Contraceptive method continuation and satisfaction</measure>
    <time_frame>6 month</time_frame>
    <description>Questionnaire is used to report continued use and satisfaction with multiple choice answer: very satisfied, somewhat satisfied, dissatisfied. Questionnaires will be administered at 3 months and 6 months after recruitment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>History of unintended pregnancy</measure>
    <time_frame>6 months</time_frame>
    <description>Measured with questionnaire at baseline, 3 months, and 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Medical Condition</measure>
    <time_frame>6 months</time_frame>
    <description>Measured with questionnaire at 3 months and 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>History of contraceptive methods used</measure>
    <time_frame>6 months</time_frame>
    <description>Measured with questionnaire at baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>If Contraception is Accessed in post-partum or post-abortion setting</measure>
    <time_frame>6 months</time_frame>
    <description>Measured with questionnaire at baseline, 3 months, and 6 months</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">97</enrollment>
  <condition>Diabetes</condition>
  <condition>Cardiovascular Disease</condition>
  <condition>Epilepsy</condition>
  <condition>Migraine</condition>
  <condition>Neurological Disorders</condition>
  <condition>Cancer</condition>
  <condition>Bariatric Surgery Candidate</condition>
  <condition>Organ or Tissue Transplant; Complications</condition>
  <condition>Lupus Erythematosus, Systemic</condition>
  <condition>Other Hematologic Conditions</condition>
  <condition>Other Venous Embolism and Thrombosis</condition>
  <arm_group>
    <arm_group_label>Medically complex contraception users</arm_group_label>
    <description>Cohort includes women of reproductive age with diverse medical conditions (listed in inclusion criteria) who are referred to Family Planning felowship-trained physicians, seeking contraception counseling and administration.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will consist of women 18-45 years old and seeking contraception with&#xD;
        the medical condition listed in inclusion criteria. Participants will be recruited from&#xD;
        obstetrics and gynecology clinic at UCSD, UCLA, UCSF, UC Irvine and UC Davis. 250&#xD;
        participants will be enrolled. Approximately 50 cases will be recruited at each site.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Ethnic Background: No limitation, will include minorities&#xD;
&#xD;
          2. Sexually Active with men&#xD;
&#xD;
          3. Diagnosis with at least one of the following conditions&#xD;
&#xD;
               -  Diabetes and other endocrine disorders&#xD;
&#xD;
               -  Cardiovascular Disease, such as Ischemic Heart Disease, Valvular disease,&#xD;
                  hypertension or pulmonary hypertension&#xD;
&#xD;
               -  Epilepsy, Migraine, and other neurologic disorders&#xD;
&#xD;
               -  History of or current cancer&#xD;
&#xD;
               -  History of or planning Bariatric Surgery&#xD;
&#xD;
               -  History of or planning Solid Organ Transplant&#xD;
&#xD;
               -  Systematic Lupus Erythematous and other rheumatologic conditions&#xD;
&#xD;
               -  History of or current Venous Thrombosis Embolism&#xD;
&#xD;
               -  Other Medical Conditions (such as Sickle Cell Disease or Cystic Fibrosis)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant at time of recruitment&#xD;
&#xD;
          2. History of hysterectomy, bilateral oophorectomy, or sterilization procedure&#xD;
&#xD;
          3. Unable to provide informed consent&#xD;
&#xD;
          4. Attempting to become pregnant at time of recruitment&#xD;
&#xD;
          5. Not sexually active with men&#xD;
&#xD;
          6. No active telephone number or email for follow up&#xD;
&#xD;
        Women who are pregnant will be excluded from this study. However, no pregnancy testing will&#xD;
        be conducted; pregnancy status will be based on self-reporting by subjects.&#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>Jody Steinauer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Radhika Rible, MD MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tabetha Harken, MD MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>UC Irvine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Catherine Cansino, MD MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>UC Davis</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sheila Mody, MD MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCSD</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCLA</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC Irvine</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC Davis</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCSD</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCSF</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Center for Disease Control and Prevention. U.S Medical Eligibility Criteria for Contraceptive Use, 2010.MMWR 2010;59 (No.RR-4).76-81</citation>
  </reference>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>August 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>March 13, 2018</last_update_submitted>
  <last_update_submitted_qc>March 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Diego</investigator_affiliation>
    <investigator_full_name>Sheila Mody</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>contraception</keyword>
  <keyword>family planning</keyword>
  <keyword>complex medical conditions</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nervous System Diseases</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Embolism</mesh_term>
    <mesh_term>Embolism and Thrombosis</mesh_term>
    <mesh_term>Lupus Erythematosus, Systemic</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/NCT02219269
org study id: 140166
nct id: NCT02219269
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The investigators will conduct a prospective observational cohort study to investigate
      factors that influence contraceptive method utilization among women with medical conditions.
      The investigators will also investigate how women with medical conditions access to
      contraception and family planning fellowship trained specialist. After the baseline
      questionnaire, there be a 3 month and 6 month follow up questionnaire to investigate
      continuation and satisfaction with the contraceptive method. This study is unique because it
      will allow us to explore doing collaborative family planning research at the multiple UC
      medical campuses.
Many women with complex medical conditions who do not desire pregnancy do not receive
      contraception counseling from their primary or subspecialty care clinicians, and often they
      are not using contraception. This is an important deficiency as many have conditions that
      could worsen with pregnancy or for whom pregnancy can be complicated by the medical
      condition. Thus it is important for women with chronic disease to only become pregnant if
      they intend to do so. The United States Medical Eligibility Criteria for Contraceptive Use
      (USMEC), released in 2010, has greatly enhanced the ability of clinicians to counsel patient
      with complex medical conditions about their contraceptive options. It summarizes the safety
      of specific contraceptives when used on women with medical conditions. However, little is
      known about the contraceptive care of these women. We do not know if the availability of the
      USMEC has translated into evidence-based contraceptive counseling for these women. Further,
      little is known about their understanding of the interaction between their disease and
      pregnancy, their past experience and knowledge about contraception, and their contraceptive
      decision-making, satisfaction and continuation.

      The purpose of the Complex Contraception Registry to is to recruit a cohort of women with
      complex medical conditions who are seen in contraception referral practices run by family
      planning fellowship trained physicians. We will assess their past experiences and baseline
      knowledge, their post-counseling experiences and choice of contraception, and their long-term
      satisfaction with and continuation of contraception. A multi-center registry is necessary
      because individual institutions see relatively few women with rare diseases such as a history
      of transplant surgery. The UC Family Planning Collaborative will facilitate recruitment of
      participants from the 5 UC medical campuses and will oversee their follow-up for one year.

      Specific Aim include (1.) To investigate what factors influence contraceptive method
      utilization among women with complex medical conditions and their perceived risk of
      unintended pregnancy (2) To investigate how women with complex medical conditions access
      family planning fellowship trained specialist for contraception counseling and (3.) To assess
      satisfaction and continuation of contraceptive methods among women with complex medical
      conditions.
observational model: Cohort
time perspective: Prospective
measure: Contraceptive method continuation and satisfaction
time frame: 6 month
description: Questionnaire is used to report continued use and satisfaction with multiple choice answer: very satisfied, somewhat satisfied, dissatisfied. Questionnaires will be administered at 3 months and 6 months after recruitment.
measure: History of unintended pregnancy
time frame: 6 months
description: Measured with questionnaire at baseline, 3 months, and 6 months
measure: Change in Medical Condition
time frame: 6 months
description: Measured with questionnaire at 3 months and 6 months
measure: History of contraceptive methods used
time frame: 6 months
description: Measured with questionnaire at baseline
measure: If Contraception is Accessed in post-partum or post-abortion setting
time frame: 6 months
description: Measured with questionnaire at baseline, 3 months, and 6 months
arm group label: Medically complex contraception users
description: Cohort includes women of reproductive age with diverse medical conditions (listed in inclusion criteria) who are referred to Family Planning felowship-trained physicians, seeking contraception counseling and administration.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Jody Steinauer, MD
role: Principal Investigator
affiliation: University of California, San Francisco
last name: Radhika Rible, MD MS
role: Principal Investigator
affiliation: University of California, Los Angeles
last name: Tabetha Harken, MD MPH
role: Principal Investigator
affiliation: UC Irvine
last name: Catherine Cansino, MD MPH
role: Principal Investigator
affiliation: UC Davis
last name: Sheila Mody, MD MPH
role: Principal Investigator
affiliation: UCSD
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Center for Disease Control and Prevention. U.S Medical Eligibility Criteria for Contraceptive Use, 2010.MMWR 2010;59 (No.RR-4).76-81
responsible party type: Principal Investigator
investigator affiliation: University of California, San Diego
investigator full name: Sheila Mody
investigator title: Assistant Professor
mesh term: Nervous System Diseases
mesh term: Cardiovascular Diseases
mesh term: Thrombosis
mesh term: Embolism
mesh term: Embolism and Thrombosis
mesh term: Lupus Erythematosus, Systemic