<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/NCT04474548</url>
  </required_header>
  <id_info>
    <org_study_id>20D.502</org_study_id>
    <nct_id>NCT04474548</nct_id>
  </id_info>
  <brief_title>Postplacental LNG-IUD Ultrasound Use Study</brief_title>
  <acronym>PLUS</acronym>
  <official_title>Postplacental LNG-IUD Ultrasound Use Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Thomas Jefferson University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Thomas Jefferson University</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>
      This study will enroll women planning to have an intrauterine device (IUD) placed for&#xD;
      contraception immediately following a vaginal delivery. Women will be randomized to have this&#xD;
      procedure done with or without ultrasound guidance. We intend to determine if the routine use&#xD;
      of ultrasound to confirm device position reduces the rates of IUD expulsion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be screened and consented for participation in the study when they are&#xD;
      admitted to Labor and Delivery for delivery and express desire for a post-placental LNG-IUD.&#xD;
      If the patient consents for study participation and meets eligibility criteria above, she&#xD;
      will be enrolled in the study after achieving vaginal delivery when she is randomized to&#xD;
      either IUD insertion with ultrasound or without ultrasound use. See protocol for detailed&#xD;
      description of IUD placement and ultrasound use.&#xD;
&#xD;
      After placement of IUD with or without ultrasound guidance, patients will be scheduled for a&#xD;
      routine postpartum follow-up visit 6-10 weeks after delivery. At the postpartum follow-up&#xD;
      visit, providers will assess for IUD expulsion with usual clinical practice, including&#xD;
      history, pelvic exam, and additional imaging if IUD strings are not visualized on exam.&#xD;
      Several attempts to contact participants who do not attend their postpartum visits will be&#xD;
      made to attempt to reschedule appointments and conduct a phone questionnaire assessing for&#xD;
      IUD expulsion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 5, 2020</start_date>
  <completion_date type="Anticipated">September 2023</completion_date>
  <primary_completion_date type="Anticipated">October 2022</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>Prevention</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>IUD expulsion</measure>
    <time_frame>6-10 weeks</time_frame>
    <description>The primary objective is to determine whether the expulsion rate of the LNG-releasing IUD within a 6-10 week period would be different when inserted with ultrasound guidance or with no ultrasound confirmation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>IUD insertion complication</measure>
    <time_frame>6-10 weeks</time_frame>
    <description>To determine if rate of complication with insertion, such as uterine perforation rates, infection rates, or bleeding rates, are different with or without ultrasound guidance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Receiving IUD</measure>
    <time_frame>6-10 weeks</time_frame>
    <description>To determine what percentage of patients who desire a post-placental IUD after delivery are able to receive one and to determine if enrolled patients that cannot get an immediate post-placental IUD get an IUD within 6-10 weeks after delivery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">254</enrollment>
  <condition>IUD Insertion Complication</condition>
  <arm_group>
    <arm_group_label>Ultrasound</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For participants randomly assigned to ultrasound use, a bedside ultrasound will be performed using the trans-abdominal probe during and/or immediately after placement of the IUD. The distance from the IUD arms to the fundus will be measured with the ultrasound, and the IUD will be defined as being &quot;in place&quot; when the distance from the top of the IUD to the fundus is measured to be 3mm or less. If the distance is greater than 4mm, the provider may reposition the IUD manually or with a ring forceps.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No ultrasound</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>For participants randomly assigned to no ultrasound use, provider will insert the IUD with a ring forceps and will use palpation of the fundus to determine whether or not the IUD is likely in place.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ultrasound use</intervention_name>
    <description>Ultrasound will be used to determine location of IUD after insertion.</description>
    <arm_group_label>Ultrasound</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients admitted to Thomas Jefferson University Labor and Delivery who desire and&#xD;
             consent to post-placental LNG-IUD placement&#xD;
&#xD;
          -  English- and Spanish- speaking patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing planned or unplanned Cesarean delivery&#xD;
&#xD;
          -  Patients who have an allergy or other contraindication to use of LNG-IUD&#xD;
&#xD;
          -  Patients who tested positive for gonorrhea or chlamydia during pregnancy without&#xD;
             treatment and a subsequent negative test of cure&#xD;
&#xD;
          -  Patients with one or more leiomyomata greater than 3 cm in diameter impinging the&#xD;
             uterine cavity&#xD;
&#xD;
          -  Clinical diagnosis of chorioamnionitis or presumed chorioamnionitis in labor&#xD;
&#xD;
          -  Postpartum hemorrhage as defined by need for transfusion, estimated blood loss greater&#xD;
             than 1000mL, or use of 3 or more doses of uterotonic medications&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lisa Perriera, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Thomas Jefferson University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Danielle Tsevat, MD</last_name>
    <phone>215-955-5000</phone>
    <email>danielle.tsevat@jefferson.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lisa Perriera, MD, MPH</last_name>
    <email>lisa.perriera@jefferson.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Thomas Jefferson University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lisa Perriera, MD, MPH</last_name>
      <email>lisa.perriera@jefferson.edu</email>
    </contact>
    <contact_backup>
      <last_name>Danielle Tsevat, MD</last_name>
      <email>danielle.tsevat@jefferson.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Danielle Tsevat, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Lisa Perriera, MD,MPH</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Rebecca Mercier, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>October 20, 2020</last_update_submitted>
  <last_update_submitted_qc>October 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>IUD</keyword>
  <keyword>Postpartum</keyword>
  <keyword>Ultrasound</keyword>
  <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/NCT04474548
org study id: 20D.502
nct id: NCT04474548
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will enroll women planning to have an intrauterine device (IUD) placed for
      contraception immediately following a vaginal delivery. Women will be randomized to have this
      procedure done with or without ultrasound guidance. We intend to determine if the routine use
      of ultrasound to confirm device position reduces the rates of IUD expulsion.
Participants will be screened and consented for participation in the study when they are
      admitted to Labor and Delivery for delivery and express desire for a post-placental LNG-IUD.
      If the patient consents for study participation and meets eligibility criteria above, she
      will be enrolled in the study after achieving vaginal delivery when she is randomized to
      either IUD insertion with ultrasound or without ultrasound use. See protocol for detailed
      description of IUD placement and ultrasound use.

      After placement of IUD with or without ultrasound guidance, patients will be scheduled for a
      routine postpartum follow-up visit 6-10 weeks after delivery. At the postpartum follow-up
      visit, providers will assess for IUD expulsion with usual clinical practice, including
      history, pelvic exam, and additional imaging if IUD strings are not visualized on exam.
      Several attempts to contact participants who do not attend their postpartum visits will be
      made to attempt to reschedule appointments and conduct a phone questionnaire assessing for
      IUD expulsion.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Care Provider)
measure: IUD expulsion
time frame: 6-10 weeks
description: The primary objective is to determine whether the expulsion rate of the LNG-releasing IUD within a 6-10 week period would be different when inserted with ultrasound guidance or with no ultrasound confirmation
measure: IUD insertion complication
time frame: 6-10 weeks
description: To determine if rate of complication with insertion, such as uterine perforation rates, infection rates, or bleeding rates, are different with or without ultrasound guidance
measure: Receiving IUD
time frame: 6-10 weeks
description: To determine what percentage of patients who desire a post-placental IUD after delivery are able to receive one and to determine if enrolled patients that cannot get an immediate post-placental IUD get an IUD within 6-10 weeks after delivery
arm group label: Ultrasound
arm group type: Experimental
description: For participants randomly assigned to ultrasound use, a bedside ultrasound will be performed using the trans-abdominal probe during and/or immediately after placement of the IUD. The distance from the IUD arms to the fundus will be measured with the ultrasound, and the IUD will be defined as being "in place" when the distance from the top of the IUD to the fundus is measured to be 3mm or less. If the distance is greater than 4mm, the provider may reposition the IUD manually or with a ring forceps.
arm group label: No ultrasound
arm group type: No Intervention
description: For participants randomly assigned to no ultrasound use, provider will insert the IUD with a ring forceps and will use palpation of the fundus to determine whether or not the IUD is likely in place.
intervention type: Other
intervention name: Ultrasound use
description: Ultrasound will be used to determine location of IUD after insertion.
arm group label: Ultrasound
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Lisa Perriera, MD, MPH
role: Principal Investigator
affiliation: Thomas Jefferson University
last name: Danielle Tsevat, MD
phone: 215-955-5000
email: danielle.tsevat@jefferson.edu
last name: Lisa Perriera, MD, MPH
email: lisa.perriera@jefferson.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Sponsor
sharing ipd: No