<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/NCT03002441</url>
  </required_header>
  <id_info>
    <org_study_id>Same Day CPrep</org_study_id>
    <nct_id>NCT03002441</nct_id>
  </id_info>
  <brief_title>Same-day Cervical Preparation Before Dilation and Evacuation</brief_title>
  <official_title>Same-day Cervical Preparation With Dilapan-S™ Plus Buccal Misoprostol Compared to Overnight Dilapan-S™ Before Dilation and Evacuation at 16 to 20 Weeks' Gestation: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Planned Parenthood of Greater New York</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Planned Parenthood of Greater New York</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this randomized trial is to compare same-day cervical preparation using&#xD;
      Dilapan-S™ plus buccal misoprostol to overnight cervical preparation using Dilapan-S™ before&#xD;
      D&amp;E at 16.0 to 20.0 weeks.&#xD;
&#xD;
      Primary objective: To compare D&amp;E operative time. We hypothesize that same-day Dilapan-S™&#xD;
      plus buccal misoprostol is non-inferior to overnight Dilapan-S™ with respect to operative&#xD;
      time.&#xD;
&#xD;
      Secondary objectives: To compare treatment groups for the following: Pre-operative cervical&#xD;
      dilation; need for mechanical dilation and ease of dilation if required; ability to complete&#xD;
      D&amp;E without further cervical preparation; ease of D&amp;E; complications; pain; side effects;&#xD;
      patient and provider satisfaction.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">February 28, 2020</completion_date>
  <primary_completion_date type="Actual">December 2019</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Operative time</measure>
    <time_frame>From initiation of D&amp;E procedure to completion of D&amp;E procedure, Study Day 2</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Cervical Dilation Prior to Dilation and Evacuation</condition>
  <arm_group>
    <arm_group_label>Same-day Dilators</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will have Dilapan-S cervical dilators placed 4-6 hours prior to D&amp;E and will receive 400 mcg buccal misoprostol pills 3 hours prior to D&amp;E.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Overnight dilators</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will have Dilapan-S cervical dilators placed the day prior to their D&amp;E procedure and will receive buccal placebo pills (vitamin B12) 3 hours prior to D&amp;E.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Same-Day Dilapan-S</intervention_name>
    <description>Dilapan-S cervical dilators placed the same day as the D&amp;E procedure</description>
    <arm_group_label>Same-day Dilators</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Overnight Dilapan-S</intervention_name>
    <description>Dilapan-S cervical dilators placed the day prior to D&amp;E procedure</description>
    <arm_group_label>Overnight dilators</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age and older&#xD;
&#xD;
          -  Seeking pregnancy termination from 16 0/7 to 19 6/7 weeks of gestation on the day of&#xD;
             enrollment.&#xD;
&#xD;
          -  Eligible for pregnancy termination at PPNYC&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active bleeding or hemodynamically unstable at enrollment&#xD;
&#xD;
          -  Signs of chorioamnionitis or clinical infection at enrollment&#xD;
&#xD;
          -  Signs of spontaneous labor or cervical insufficiency at enrollment&#xD;
&#xD;
          -  Spontaneous intrauterine fetal demise&#xD;
&#xD;
          -  Allergy to Dilapan-S™ or misoprostol&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ila Dayananda</last_name>
    <role>Principal Investigator</role>
    <affiliation>Planned Parenthood of Greater New York</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Planned Parenthood of Greater New York</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>April 21, 2021</last_update_submitted>
  <last_update_submitted_qc>April 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dilatation, Pathologic</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/NCT03002441
org study id: Same Day CPrep
nct id: NCT03002441
lead sponsor: 
has dmc: No
The purpose of this randomized trial is to compare same-day cervical preparation using
      Dilapan-S™ plus buccal misoprostol to overnight cervical preparation using Dilapan-S™ before
      D&E at 16.0 to 20.0 weeks.

      Primary objective: To compare D&E operative time. We hypothesize that same-day Dilapan-S™
      plus buccal misoprostol is non-inferior to overnight Dilapan-S™ with respect to operative
      time.

      Secondary objectives: To compare treatment groups for the following: Pre-operative cervical
      dilation; need for mechanical dilation and ease of dilation if required; ability to complete
      D&E without further cervical preparation; ease of D&E; complications; pain; side effects;
      patient and provider satisfaction.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Operative time
time frame: From initiation of D&E procedure to completion of D&E procedure, Study Day 2
arm group label: Same-day Dilators
arm group type: Active Comparator
description: Participants will have Dilapan-S cervical dilators placed 4-6 hours prior to D&E and will receive 400 mcg buccal misoprostol pills 3 hours prior to D&E.
arm group label: Overnight dilators
arm group type: Active Comparator
description: Participants will have Dilapan-S cervical dilators placed the day prior to their D&E procedure and will receive buccal placebo pills (vitamin B12) 3 hours prior to D&E.
intervention type: Device
intervention name: Same-Day Dilapan-S
description: Dilapan-S cervical dilators placed the same day as the D&E procedure
arm group label: Same-day Dilators
intervention type: Device
intervention name: Overnight Dilapan-S
description: Dilapan-S cervical dilators placed the day prior to D&E procedure
arm group label: Overnight dilators
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ila Dayananda
role: Principal Investigator
affiliation: Planned Parenthood of Greater New York
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dilatation, Pathologic
sharing ipd: No