<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/NCT02220205</url>
  </required_header>
  <id_info>
    <org_study_id>2014P-000106</org_study_id>
    <nct_id>NCT02220205</nct_id>
  </id_info>
  <brief_title>Evaluation of the PelvicSim Simulator for Training in Intrauterine Device Insertions</brief_title>
  <official_title>Evaluation of the PelvicSim Simulator for Training in Intrauterine Device Insertions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beth Israel Deaconess Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beth Israel Deaconess Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Intrauterine devices (IUDs) are a very effective, long-acting method of contraception. In&#xD;
      order to make them accessible to women, health care providers must be trained to insert them.&#xD;
      Physicians, physician assistant, and nurse practitioners often learn how to do so by first&#xD;
      learning about IUDs, then practicing on a model that the IUD manufacturer provides.&#xD;
&#xD;
      Educators have recently been using more sophisticated models to teach clinical skills such as&#xD;
      surgical procedures. We are investigating whether these models may be more useful in teaching&#xD;
      IUD insertion.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Insertion Score Before and Immediately After Initial Practice (Same Day), and 3 Months After Initial Practice</measure>
    <time_frame>Before and immediately after initial practice on assigned simulator (same day), and three months after initial practice</time_frame>
    <description>Participants were filmed performing 3 IUD insertions each, for three IUDs available in the US. They then practiced on an assigned simulator for 30 minutes, and were re-recorded immediately afterwards. Three months after initial practice, they returned and performed the insertions again.&#xD;
Sets of insertions were scored using a checklist. Participants earned up to 86 points for performing various elements of IUC insertion correctly: sounding the uterus (14 points), and loading as well as inserting the copper device (24 points), levonorgestrel 52mg device (26 points), and levonorgestrel 13.5mg device (22 points). Higher scores were better.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent Change in Comfort Placing IUDs From Pre- to Post-insertion</measure>
    <time_frame>Baseline to three months</time_frame>
    <description>Participants were given questionnaires at the initial study visit and at a three-month follow-up visit that assessed their comfort with IUD insertion using a modified Likert scale.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Contraceptive Devices, Intrauterine</condition>
  <condition>Education, Medical</condition>
  <arm_group>
    <arm_group_label>PelvicSim</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Manufacturer model</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PelvicSim</intervention_name>
    <arm_group_label>PelvicSim</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Manufacturer model</intervention_name>
    <arm_group_label>Manufacturer model</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  First-year residents in obstetrics and gynecology or family medicine, or student in&#xD;
             physician assistant or nurse practitioner training programs&#xD;
&#xD;
          -  Trainees who have performed &lt;5 intrauterine device insertions&#xD;
&#xD;
          -  Trainees who plan to provide intrauterine devices in their clinical practice&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</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>Siripanth Nippita, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beth Israel Deaconess Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <results_first_submitted>July 27, 2016</results_first_submitted>
  <results_first_submitted_qc>April 21, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">May 24, 2017</results_first_posted>
  <last_update_submitted>April 21, 2017</last_update_submitted>
  <last_update_submitted_qc>April 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beth Israel Deaconess Medical Center</investigator_affiliation>
    <investigator_full_name>Siripanth Nippita</investigator_full_name>
    <investigator_title>Instructor in Obstetrics, Gynecology and Reproductive Biology</investigator_title>
  </responsible_party>
  <keyword>IUD</keyword>
  <keyword>training</keyword>
  <keyword>simulation</keyword>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>One participant voluntarily withdrew from the study due to time constraints which precluded completion of the study visit. Therefore, 60 participants enrolled and were randomized, and 59 completed the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>PelvicSim</title>
          <description>Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes.&#xD;
PelvicSim</description>
        </group>
        <group group_id="P2">
          <title>Manufacturer Model</title>
          <description>Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes.&#xD;
Manufacturer model</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>PelvicSim</title>
          <description>Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes.&#xD;
PelvicSim</description>
        </group>
        <group group_id="B2">
          <title>Manufacturer Model</title>
          <description>Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes.&#xD;
Manufacturer model</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="29"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="59"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26" lower_limit="26" upper_limit="30"/>
                    <measurement group_id="B2" value="28" lower_limit="26" upper_limit="30"/>
                    <measurement group_id="B3" value="27" lower_limit="26" upper_limit="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Occupation</title>
          <description>Intern or NP student</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Intern</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nurse practitioner student</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior pelvic exams</title>
          <units>exams</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1-5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6-10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior IUD insertions performed</title>
          <units>exams</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>&gt;=1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Insertion Score Before and Immediately After Initial Practice (Same Day), and 3 Months After Initial Practice</title>
        <description>Participants were filmed performing 3 IUD insertions each, for three IUDs available in the US. They then practiced on an assigned simulator for 30 minutes, and were re-recorded immediately afterwards. Three months after initial practice, they returned and performed the insertions again.&#xD;
Sets of insertions were scored using a checklist. Participants earned up to 86 points for performing various elements of IUC insertion correctly: sounding the uterus (14 points), and loading as well as inserting the copper device (24 points), levonorgestrel 52mg device (26 points), and levonorgestrel 13.5mg device (22 points). Higher scores were better.</description>
        <time_frame>Before and immediately after initial practice on assigned simulator (same day), and three months after initial practice</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PelvicSim</title>
            <description>Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes.&#xD;
PelvicSim</description>
          </group>
          <group group_id="O2">
            <title>Manufacturer Model</title>
            <description>Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes.&#xD;
Manufacturer model</description>
          </group>
        </group_list>
        <measure>
          <title>Insertion Score Before and Immediately After Initial Practice (Same Day), and 3 Months After Initial Practice</title>
          <description>Participants were filmed performing 3 IUD insertions each, for three IUDs available in the US. They then practiced on an assigned simulator for 30 minutes, and were re-recorded immediately afterwards. Three months after initial practice, they returned and performed the insertions again.&#xD;
Sets of insertions were scored using a checklist. Participants earned up to 86 points for performing various elements of IUC insertion correctly: sounding the uterus (14 points), and loading as well as inserting the copper device (24 points), levonorgestrel 52mg device (26 points), and levonorgestrel 13.5mg device (22 points). Higher scores were better.</description>
          <units>Percent of tasks performed correctly</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-simulation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.5" lower_limit="50" upper_limit="69"/>
                    <measurement group_id="O2" value="67.5" lower_limit="53" upper_limit="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-simulation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.5" lower_limit="72" upper_limit="88"/>
                    <measurement group_id="O2" value="83" lower_limit="73" upper_limit="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Three month visit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.5" lower_limit="58" upper_limit="75"/>
                    <measurement group_id="O2" value="67.5" lower_limit="59" upper_limit="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change in Comfort Placing IUDs From Pre- to Post-insertion</title>
        <description>Participants were given questionnaires at the initial study visit and at a three-month follow-up visit that assessed their comfort with IUD insertion using a modified Likert scale.</description>
        <time_frame>Baseline to three months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PelvicSim</title>
            <description>Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes.&#xD;
PelvicSim</description>
          </group>
          <group group_id="O2">
            <title>Manufacturer Model</title>
            <description>Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes.&#xD;
Manufacturer model</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change in Comfort Placing IUDs From Pre- to Post-insertion</title>
          <description>Participants were given questionnaires at the initial study visit and at a three-month follow-up visit that assessed their comfort with IUD insertion using a modified Likert scale.</description>
          <units>Percent change in comfort</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Copper IUD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.3"/>
                    <measurement group_id="O2" value="96.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>52mg levonorgestrel IUD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.9"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>13.5mg levonorgestrel IUD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.3"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>PelvicSim</title>
          <description>Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes.&#xD;
PelvicSim</description>
        </group>
        <group group_id="E2">
          <title>Manufacturer Model</title>
          <description>Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes.&#xD;
Manufacturer model</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Participants directed their own practice time. An investigator answered questions but did not provide other feedback unless specifically asked.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Siripanth Nippita</name_or_title>
      <organization>Beth Israel Deaconess Medical Center</organization>
      <phone>617-667-4165</phone>
      <email>snippita@bidmc.harvard.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02220205
org study id: 2014P-000106
nct id: NCT02220205
lead sponsor: 
has dmc: No
Intrauterine devices (IUDs) are a very effective, long-acting method of contraception. In
      order to make them accessible to women, health care providers must be trained to insert them.
      Physicians, physician assistant, and nurse practitioners often learn how to do so by first
      learning about IUDs, then practicing on a model that the IUD manufacturer provides.

      Educators have recently been using more sophisticated models to teach clinical skills such as
      surgical procedures. We are investigating whether these models may be more useful in teaching
      IUD insertion.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: Insertion Score Before and Immediately After Initial Practice (Same Day), and 3 Months After Initial Practice
time frame: Before and immediately after initial practice on assigned simulator (same day), and three months after initial practice
description: Participants were filmed performing 3 IUD insertions each, for three IUDs available in the US. They then practiced on an assigned simulator for 30 minutes, and were re-recorded immediately afterwards. Three months after initial practice, they returned and performed the insertions again.
Sets of insertions were scored using a checklist. Participants earned up to 86 points for performing various elements of IUC insertion correctly: sounding the uterus (14 points), and loading as well as inserting the copper device (24 points), levonorgestrel 52mg device (26 points), and levonorgestrel 13.5mg device (22 points). Higher scores were better.
measure: Percent Change in Comfort Placing IUDs From Pre- to Post-insertion
time frame: Baseline to three months
description: Participants were given questionnaires at the initial study visit and at a three-month follow-up visit that assessed their comfort with IUD insertion using a modified Likert scale.
arm group label: PelvicSim
arm group type: Active Comparator
description: Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes.
arm group label: Manufacturer model
arm group type: Placebo Comparator
description: Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes.
intervention type: Other
intervention name: PelvicSim
arm group label: PelvicSim
intervention type: Device
intervention name: Manufacturer model
arm group label: Manufacturer model
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Siripanth Nippita, MD, MS
role: Principal Investigator
affiliation: Beth Israel Deaconess Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Beth Israel Deaconess Medical Center
investigator full name: Siripanth Nippita
investigator title: Instructor in Obstetrics, Gynecology and Reproductive Biology
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Participants directed their own practice time. An investigator answered questions but did not provide other feedback unless specifically asked.
point of contact: 