<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/NCT03833284</url>
  </required_header>
  <id_info>
    <org_study_id>45131</org_study_id>
    <nct_id>NCT03833284</nct_id>
  </id_info>
  <brief_title>Transvaginal Ultrasound: Preterm Birth Prevention in Appalachia</brief_title>
  <official_title>Implementation of a Transvaginal Ultrasound Surveillance Program in Women With a History of Previous Preterm Birth: Disseminating Evidenced Based Practices for Reducing Preterm Birth in Appalachian Kentucky</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Niraj Chavan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kentucky</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>
      Preterm Birth is the number one cause of infant morbidity and mortality worldwide and&#xD;
      represents an important health disparity in the United States, particularly across the state&#xD;
      of Kentucky. The best biomarker for the prediction of preterm birth is transvaginal&#xD;
      ultrasound (TVU). This study will attempt to identify and rectify provider and patient&#xD;
      related barriers to TVU screening implementation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Preterm birth is the number one cause of infant morbidity and mortality worldwide and&#xD;
      represents an important health disparity in the United States, and especially across the&#xD;
      state of Kentucky. The best biomarker for the prediction of preterm birth is transvaginal&#xD;
      ultrasound (TVU) measurement of cervical length. However, several unique provider and patient&#xD;
      related barriers for implementation of this screening limit the widespread uptake of this&#xD;
      evidence based practice in Appalachian KY. The investigators propose to adopt a dissemination&#xD;
      and implementation science approach using the Consolidated Framework for Implementation&#xD;
      Research (CFIR) as the guiding framework for identification of key areas of knowledge&#xD;
      deficits as well as attitudes, practices and perceived barriers among prenatal care providers&#xD;
      and patients in eastern KY towards TVU cervical length screening using a mixed - methods&#xD;
      design. This will be utilized to develop a multifaceted implementation strategy best suited&#xD;
      for addressing and overcoming barriers identified by the target population in eastern KY. The&#xD;
      investigators anticipate that such an implementation strategy will likely include an&#xD;
      educational component targeting obstetric care providers and patients in addition to hands-on&#xD;
      TVU cervical length evaluation as well as telemedicine support and surveillance. Three&#xD;
      community based sites (Hazard, Morehead and Ashland, KY) will be recruited for implementation&#xD;
      of this multi-component pilot program focused on community engagement and outreach targeting&#xD;
      obstetric providers and their patients. At the end of the pilot implementation phase,&#xD;
      acceptability of the study intervention and feasibility of implementation will be evaluated&#xD;
      along with a preliminary assessment of effectiveness of implementation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 3, 2019</start_date>
  <completion_date type="Actual">October 29, 2021</completion_date>
  <primary_completion_date type="Actual">October 29, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in attitudes towards TVU screening among patients and practitioners</measure>
    <time_frame>At baseline and at one year.</time_frame>
    <description>The primary purpose of this study is to evaluate the change in attitudes towards TVU screening among patients and practitioners. This will be accomplished by conducting a qualitative interview with each participant at baseline and again at one year (after completing the CLEAR program workshop).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Potential for future TVU screening implementation based on changes in attitudes towards TVU screening among providers and participants.</measure>
    <time_frame>At baseline and at one year.</time_frame>
    <description>The primary purpose of this study is to evaluate the change in attitudes towards TVU screening among patients and practitioners. This will be accomplished by conducting a qualitative interview with each participant at baseline and again at one year (after completing the CLEAR program workshop). Analysis of these interviews will aid in determining feasibility of implementing a future TVU screening component in Obstetric and Gynecologic care.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of preterm birth at &lt;34 weeks gestation</measure>
    <time_frame>Through study completion, average of 1 year from study initiation</time_frame>
    <description>Subjects (patients) included in this study will be followed to determine rate of preterm birth at various time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of preterm birth at &lt;37 weeks gestation</measure>
    <time_frame>Through study completion, average of 1 year from study initiation</time_frame>
    <description>Subjects (patients) included in this study will be followed to determine rate of preterm birth at various time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of TVU scans identifying a short cervix (≤ 25 mm) in any pregnant women at each study site</measure>
    <time_frame>Through study completion, average of 1 year from study initiation.</time_frame>
    <description>Records of TVU scans identifying a short cervix among the study population will be analyzed to determine the rate of short cervix issues among the population. The percentage will aid in determining the need for future TVU screening in similar populations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of inpatient hospitalization for preterm labor management prior to delivery</measure>
    <time_frame>Through study completion, average of 1 year from study initiation.</time_frame>
    <description>Subjects (patients) included in this study will be followed to determine whether they are subjects to hospitalization prior to birthing due to complications associated with preterm labor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of clinical therapy</measure>
    <time_frame>Through study completion, average of 1 year from study initiation.</time_frame>
    <description>Defined as prescribing vaginal progesterone or performing cervical cerclage</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Preterm Birth</condition>
  <arm_group>
    <arm_group_label>Participant Barriers to TVU Screening</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with a history of pre-term birth will be identified through a review of their medical history. Patients will then be asked to complete a survey assessing their knowledge of transvaginal ultrasound screening. Patients will then be asked to attend in-person or online workshops designed to increase patient knowledge of TVU screening guidelines and benefits. Finally, patients will complete exit surveys to determine whether their attitudes and beliefs towards screening have changed over time.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Provider Barriers to TVU Screening</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Obstetric and Gynecologic Providers will be identified based on prior working relationships with the University of Kentucky outreach programs. Chosen providers will be asked to complete a survey assessing their attitudes towards TVU screening. Following completion, providers will be asked to attend either in-person or online workshops designed to increase provider knowledge of TVU screening guidelines and benefits. Finally, providers will complete exit surveys to determine whether their attitudes and beliefs toward screening have changed over time.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Participant Barriers to TVU Screening</intervention_name>
    <description>Workshops tailored toward patients to increase knowledge about TVU screening guidelines and benefits.</description>
    <arm_group_label>Participant Barriers to TVU Screening</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Provider Barriers to TVU Screening</intervention_name>
    <description>Workshops tailored toward providers to increase knowledge about TVU screening guidelines and benefits.</description>
    <arm_group_label>Provider Barriers to TVU Screening</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: Participant&#xD;
&#xD;
          -  Female Sex&#xD;
&#xD;
          -  Prior history of preterm birth (for initial set of interviews), no preterm birth&#xD;
             history required for intervention feedback&#xD;
&#xD;
          -  Current pregnant status&#xD;
&#xD;
        Exclusion Criteria: Participant&#xD;
&#xD;
          -  Male Sex&#xD;
&#xD;
        Inclusion Criteria: Provider&#xD;
&#xD;
          -  Certified as obstetric/gynecologic provider&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Niraj Chavan</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kentucky</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Kentucky</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>January 4, 2022</last_update_submitted>
  <last_update_submitted_qc>January 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Kentucky</investigator_affiliation>
    <investigator_full_name>Niraj Chavan</investigator_full_name>
    <investigator_title>Assistant Professor in Maternal Fetal Medicine</investigator_title>
  </responsible_party>
  <keyword>Transvaginal Ultrasound</keyword>
  <keyword>Telemedicine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
  </condition_browse>
  <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/NCT03833284
org study id: 45131
nct id: NCT03833284
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Preterm Birth is the number one cause of infant morbidity and mortality worldwide and
      represents an important health disparity in the United States, particularly across the state
      of Kentucky. The best biomarker for the prediction of preterm birth is transvaginal
      ultrasound (TVU). This study will attempt to identify and rectify provider and patient
      related barriers to TVU screening implementation.
Preterm birth is the number one cause of infant morbidity and mortality worldwide and
      represents an important health disparity in the United States, and especially across the
      state of Kentucky. The best biomarker for the prediction of preterm birth is transvaginal
      ultrasound (TVU) measurement of cervical length. However, several unique provider and patient
      related barriers for implementation of this screening limit the widespread uptake of this
      evidence based practice in Appalachian KY. The investigators propose to adopt a dissemination
      and implementation science approach using the Consolidated Framework for Implementation
      Research (CFIR) as the guiding framework for identification of key areas of knowledge
      deficits as well as attitudes, practices and perceived barriers among prenatal care providers
      and patients in eastern KY towards TVU cervical length screening using a mixed - methods
      design. This will be utilized to develop a multifaceted implementation strategy best suited
      for addressing and overcoming barriers identified by the target population in eastern KY. The
      investigators anticipate that such an implementation strategy will likely include an
      educational component targeting obstetric care providers and patients in addition to hands-on
      TVU cervical length evaluation as well as telemedicine support and surveillance. Three
      community based sites (Hazard, Morehead and Ashland, KY) will be recruited for implementation
      of this multi-component pilot program focused on community engagement and outreach targeting
      obstetric providers and their patients. At the end of the pilot implementation phase,
      acceptability of the study intervention and feasibility of implementation will be evaluated
      along with a preliminary assessment of effectiveness of implementation.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: Double (Participant, Care Provider)
measure: Change in attitudes towards TVU screening among patients and practitioners
time frame: At baseline and at one year.
description: The primary purpose of this study is to evaluate the change in attitudes towards TVU screening among patients and practitioners. This will be accomplished by conducting a qualitative interview with each participant at baseline and again at one year (after completing the CLEAR program workshop).
measure: Potential for future TVU screening implementation based on changes in attitudes towards TVU screening among providers and participants.
time frame: At baseline and at one year.
description: The primary purpose of this study is to evaluate the change in attitudes towards TVU screening among patients and practitioners. This will be accomplished by conducting a qualitative interview with each participant at baseline and again at one year (after completing the CLEAR program workshop). Analysis of these interviews will aid in determining feasibility of implementing a future TVU screening component in Obstetric and Gynecologic care.
measure: Rate of preterm birth at <34 weeks gestation
time frame: Through study completion, average of 1 year from study initiation
description: Subjects (patients) included in this study will be followed to determine rate of preterm birth at various time points.
measure: Rate of preterm birth at <37 weeks gestation
time frame: Through study completion, average of 1 year from study initiation
description: Subjects (patients) included in this study will be followed to determine rate of preterm birth at various time points.
measure: Number of TVU scans identifying a short cervix (≤ 25 mm) in any pregnant women at each study site
time frame: Through study completion, average of 1 year from study initiation.
description: Records of TVU scans identifying a short cervix among the study population will be analyzed to determine the rate of short cervix issues among the population. The percentage will aid in determining the need for future TVU screening in similar populations.
measure: Rate of inpatient hospitalization for preterm labor management prior to delivery
time frame: Through study completion, average of 1 year from study initiation.
description: Subjects (patients) included in this study will be followed to determine whether they are subjects to hospitalization prior to birthing due to complications associated with preterm labor.
measure: Rates of clinical therapy
time frame: Through study completion, average of 1 year from study initiation.
description: Defined as prescribing vaginal progesterone or performing cervical cerclage
arm group label: Participant Barriers to TVU Screening
arm group type: Experimental
description: Patients with a history of pre-term birth will be identified through a review of their medical history. Patients will then be asked to complete a survey assessing their knowledge of transvaginal ultrasound screening. Patients will then be asked to attend in-person or online workshops designed to increase patient knowledge of TVU screening guidelines and benefits. Finally, patients will complete exit surveys to determine whether their attitudes and beliefs towards screening have changed over time.
arm group label: Provider Barriers to TVU Screening
arm group type: Experimental
description: Obstetric and Gynecologic Providers will be identified based on prior working relationships with the University of Kentucky outreach programs. Chosen providers will be asked to complete a survey assessing their attitudes towards TVU screening. Following completion, providers will be asked to attend either in-person or online workshops designed to increase provider knowledge of TVU screening guidelines and benefits. Finally, providers will complete exit surveys to determine whether their attitudes and beliefs toward screening have changed over time.
intervention type: Behavioral
intervention name: Participant Barriers to TVU Screening
description: Workshops tailored toward patients to increase knowledge about TVU screening guidelines and benefits.
arm group label: Participant Barriers to TVU Screening
intervention type: Behavioral
intervention name: Provider Barriers to TVU Screening
description: Workshops tailored toward providers to increase knowledge about TVU screening guidelines and benefits.
arm group label: Provider Barriers to TVU Screening
criteria: 
gender: All
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: No
last name: Niraj Chavan
role: Principal Investigator
affiliation: University of Kentucky
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Kentucky
investigator full name: Niraj Chavan
investigator title: Assistant Professor in Maternal Fetal Medicine
mesh term: Premature Birth
sharing ipd: No