<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/NCT01708330</url>
  </required_header>
  <id_info>
    <org_study_id>12-0039</org_study_id>
    <nct_id>NCT01708330</nct_id>
  </id_info>
  <brief_title>The Effect of Topical Lidocaine on Pain Scores During Manual Vacuum Aspiration for Nonviable Pregnancies</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bridgeport Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Women and Infants Hospital of Rhode Island</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Bridgeport Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      When a patient requires a manual vacuum aspiration (MVA), whether for an undesired pregnancy,&#xD;
      missed abortion, or other nonviable pregnancy, she is undergoing an emotional experience. She&#xD;
      is grieving the loss of her pregnancy, and is then faced with the anxiety of an invasive and&#xD;
      often painful procedure. Minimizing the pain during this procedure must not be overlooked.&#xD;
      There have been no randomized controlled trials evaluating pain control during MVA for&#xD;
      nonviable pregnancy, and the data is mixed regarding analgesia for MVA for an elective&#xD;
      abortion or other office procedures.&#xD;
&#xD;
      Women being treated at the Women &amp; Infants Triage who have experienced a first trimester&#xD;
      missed abortion, inevitable abortion, incomplete abortion or other nonviable pregnancy and&#xD;
      are being treated with an outpatient manual vacuum aspiration will be asked to enroll in this&#xD;
      study. Those who wish to participate will be randomly assigned to treatment with lidocaine&#xD;
      gel or a placebo gel applied to the cervix during their procedure.&#xD;
&#xD;
      The hypothesis is that topical lidocaine will decrease pain during manual vacuum aspiration.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <phase>Phase 3</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain during intracervical block</measure>
    <time_frame>immediate</time_frame>
    <description>Pain on visual analogue scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain during tenaculum placement</measure>
    <time_frame>immediate</time_frame>
    <description>Pain on visual analogue scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain during cervical dilation</measure>
    <time_frame>immediate</time_frame>
    <description>Pain on visual analogue scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain during uterine aspiration</measure>
    <time_frame>immediate</time_frame>
    <description>Pain on visual analogue scale</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Complications</measure>
    <time_frame>1 hour after procedure</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Nonviable Pregnancy</condition>
  <arm_group>
    <arm_group_label>Placebo gel</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo gel applied topically to the cervix</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lidocaine gel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2% lidocaine gel applied topically to the cervix</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine</intervention_name>
    <description>2% Lidocaine gel</description>
    <arm_group_label>Lidocaine gel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo gel</intervention_name>
    <description>odorless, colorless gel will be used as a placebo</description>
    <arm_group_label>Placebo gel</arm_group_label>
    <other_name>KY Jelly</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient at the Women and Infants Triage/Women's Emergency Department&#xD;
&#xD;
          -  Vital signs are stable&#xD;
&#xD;
          -  Ages 18 and older&#xD;
&#xD;
          -  Have a missed abortion, inevitable abortion, incomplete abortion or other nonviable&#xD;
             pregnancy&#xD;
&#xD;
          -  Estimated gestational age up to 10 weeks&#xD;
&#xD;
          -  Undergoing MVA at the Women and Infants Triage/Women's Emergency Department&#xD;
&#xD;
          -  Able to read English or Spanish&#xD;
&#xD;
          -  Able to give informed consent for involvement in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergic to lidocaine, iodine or betadine&#xD;
&#xD;
          -  Known sensitivity to any component of the lidocaine or placebo gel.&#xD;
&#xD;
          -  In acute distress&#xD;
&#xD;
          -  Unable to give informed consent&#xD;
&#xD;
          -  Unable to read English or Spanish&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Women and Infants Hospital Triage</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>July 18, 2016</last_update_submitted>
  <last_update_submitted_qc>July 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bridgeport Hospital</investigator_affiliation>
    <investigator_full_name>Amanda Tower</investigator_full_name>
    <investigator_title>Fellow</investigator_title>
  </responsible_party>
  <keyword>manual vacuum aspiration</keyword>
  <keyword>missed abortion</keyword>
  <keyword>incomplete abortion</keyword>
  <keyword>nonviable pregnancy</keyword>
  <keyword>topical lidocaine</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>January 21, 2019</submitted>
    <returned>February 12, 2019</returned>
    <submitted>January 13, 2020</submitted>
    <returned>January 22, 2020</returned>
  </pending_results>
  <!-- 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/NCT01708330
org study id: 12-0039
nct id: NCT01708330
lead sponsor: 
collaborator: 
has dmc: No
When a patient requires a manual vacuum aspiration (MVA), whether for an undesired pregnancy,
      missed abortion, or other nonviable pregnancy, she is undergoing an emotional experience. She
      is grieving the loss of her pregnancy, and is then faced with the anxiety of an invasive and
      often painful procedure. Minimizing the pain during this procedure must not be overlooked.
      There have been no randomized controlled trials evaluating pain control during MVA for
      nonviable pregnancy, and the data is mixed regarding analgesia for MVA for an elective
      abortion or other office procedures.

      Women being treated at the Women & Infants Triage who have experienced a first trimester
      missed abortion, inevitable abortion, incomplete abortion or other nonviable pregnancy and
      are being treated with an outpatient manual vacuum aspiration will be asked to enroll in this
      study. Those who wish to participate will be randomly assigned to treatment with lidocaine
      gel or a placebo gel applied to the cervix during their procedure.

      The hypothesis is that topical lidocaine will decrease pain during manual vacuum aspiration.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Pain during intracervical block
time frame: immediate
description: Pain on visual analogue scale
measure: Pain during tenaculum placement
time frame: immediate
description: Pain on visual analogue scale
measure: Pain during cervical dilation
time frame: immediate
description: Pain on visual analogue scale
measure: Pain during uterine aspiration
time frame: immediate
description: Pain on visual analogue scale
measure: Complications
time frame: 1 hour after procedure
arm group label: Placebo gel
arm group type: Placebo Comparator
description: Placebo gel applied topically to the cervix
arm group label: Lidocaine gel
arm group type: Experimental
description: 2% lidocaine gel applied topically to the cervix
intervention type: Drug
intervention name: Lidocaine
description: 2% Lidocaine gel
arm group label: Lidocaine gel
intervention type: Drug
intervention name: Placebo gel
description: odorless, colorless gel will be used as a placebo
arm group label: Placebo gel
other name: KY Jelly
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Bridgeport Hospital
investigator full name: Amanda Tower
investigator title: Fellow
mesh term: Lidocaine
submitted: January 21, 2019
returned: February 12, 2019
submitted: January 13, 2020
returned: January 22, 2020