<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/NCT03802149</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-48756</org_study_id>
    <nct_id>NCT03802149</nct_id>
  </id_info>
  <brief_title>Ulipristal Acetate for Cervical Preparation</brief_title>
  <acronym>U-Prep</acronym>
  <official_title>Cervical Preparation Using Ulipristal Acetate for Second Trimester Surgical Abortion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective cohort study exploring a broadened use of ulipristal acetate as a&#xD;
      cervical preparation agent for second trimester surgical abortion. Specifically, this pilot&#xD;
      study will test the feasibility of using ulipristal as a pharmacologic cervical preparation&#xD;
      with adjunct misoprostol prior to surgical abortion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Second trimester abortion comprises &lt;10% of all induced abortions in the United States but&#xD;
      there is still an important need to provide this service to women. Prior to dilation and&#xD;
      evacuation (D&amp;E), adequate preparation of the uterine cervix is an important part of&#xD;
      preventing complications of the procedure. Commonly, this is done using osmotic dilators that&#xD;
      are placed into the uterine cervix but cervical preparation can also be achieved using&#xD;
      medications alone. Mifepristone is commonly used for this purpose but its use is regulated&#xD;
      and often restricted due to the REMS (Risk Evaluation and Mitigation Strategy) program. The&#xD;
      objective of this pilot study is to test the feasibility of using ulipristal, an oral&#xD;
      medication similar to Mifepristone, as a medical form of cervical preparation prior to&#xD;
      surgical abortion.This is a prospective cohort study investigating the use of ulipristal&#xD;
      acetate (UPA) for pharmacologic cervical preparation with adjunct misoprostol prior to second&#xD;
      trimester surgical abortion among women who are 16 to 18 6/7 weeks gestational age. Due the&#xD;
      mechanism of action of UPA as a selective progesterone receptor modulator (SPRM) being&#xD;
      similar to that of mifepristone, a medication known to be effective for cervical preparation,&#xD;
      the investigators seek to describe the use of another SPRM for this same purpose. The&#xD;
      investigators will conduct a pilot study assessing the feasibility of using UPA for cervical&#xD;
      priming and report descriptive measures of its use. Per clinic protocols, patients over&#xD;
      16-weeks gestation attend a consult and cervical preparation appointment the day prior to&#xD;
      their procedure. Eligible patients will be offered enrollment. Subjects will receive UPA 90mg&#xD;
      one day prior to their procedure and no osmotic dilators. All subjects will receive&#xD;
      pre-procedure misoprostol (600mcg 90 minutes prior to procedure). The investigators will&#xD;
      observe patients through their planned procedure and report descriptive measures of its use.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 16, 2019</start_date>
  <completion_date type="Actual">April 2, 2020</completion_date>
  <primary_completion_date type="Actual">April 2, 2020</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adequacy of cervical dilation</measure>
    <time_frame>Intraoperative</time_frame>
    <description>Ease of dilation, measured by visual analog score (0-100mm, 0 being &quot;very easy&quot; and 100 being &quot;very difficult&quot;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Need for additional mechanical dilation</measure>
    <time_frame>Intraoperative: start of dilation to completion of dilation</time_frame>
    <description>Number of dilator increments in French required to dilate the internal os</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total procedure time</measure>
    <time_frame>Intraoperative: from speculum placement to speculum removal</time_frame>
    <description>Minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total operative time</measure>
    <time_frame>Intraoperative: insertion of the first instrument to removal of the last instrument from the uterus</time_frame>
    <description>Minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>Intraoperative and postoperative through 8-weeks</time_frame>
    <description>Number of cervical lacerations, uterine perforation, hemorrhage and need for transfer to high level of care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Pain Experienced</measure>
    <time_frame>20-minutes postoperative</time_frame>
    <description>0-100mm on visual analog scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of procedures completed as scheduled</measure>
    <time_frame>Time from enrollment to completion of procedure</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Termination of Pregnancy</condition>
  <arm_group>
    <arm_group_label>Ulipristal Acetate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be administered a one time dose of 90mg ulipristal acetate 18-24-hours prior to dilation and evacuation (surgical abortion) for cervical preparation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ulipristal Acetate</intervention_name>
    <description>90mg Ulipristal Acetate 18-24-hours prior to dilation and evacuation</description>
    <arm_group_label>Ulipristal Acetate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female, aged 18 years or older&#xD;
&#xD;
          -  Singleton, viable intrauterine pregnancy between 16 to 18 6/7 weeks of gestation (by&#xD;
             ultrasound dating performed prior to or same day of enrollment visit)&#xD;
&#xD;
          -  Consented for an induced, elective abortion&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
          -  Able to consent for research project&#xD;
&#xD;
          -  Willingness to comply with study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to give informed consent&#xD;
&#xD;
          -  Contraindications to surgical abortion under moderate sedation&#xD;
&#xD;
          -  Allergy or previous unacceptable side effect from study medications&#xD;
&#xD;
          -  Multiple gestation&#xD;
&#xD;
          -  Intrauterine fetal demise or spontaneous abortion&#xD;
&#xD;
          -  Rupture of membranes&#xD;
&#xD;
          -  Current cervical insufficiency&#xD;
&#xD;
          -  History of liver disease&#xD;
&#xD;
          -  Taken a CYP3A4 inhibitor within 5 elimination half-lives of the drug from the&#xD;
             procedure&#xD;
&#xD;
          -  Pre-dosing abnormal liver function tests&#xD;
&#xD;
          -  Patients at increased risk of hepatitis based on a history of any of the following:&#xD;
&#xD;
          -  Any history of underlying liver disorder, including hepatitis&#xD;
&#xD;
          -  A family history of hepatitis or currently living with a person who has been given a&#xD;
             diagnosis of hepatitis&#xD;
&#xD;
          -  A history of or currently working as a sex worker&#xD;
&#xD;
          -  A history of or currently using IV drugs&#xD;
&#xD;
          -  A self-reported history of alcoholic dependency or abuse&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Principal Investigator, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford Health Care</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>June 30, 2020</last_update_submitted>
  <last_update_submitted_qc>June 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ulipristal Acetate</keyword>
  <keyword>Abortion</keyword>
  <keyword>Cervical Preparation</keyword>
  <keyword>Dilation and Evacuation</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ulipristal acetate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Will assess IPD sharing upon request.</ipd_description>
  </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/NCT03802149
org study id: IRB-48756
nct id: NCT03802149
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This is a prospective cohort study exploring a broadened use of ulipristal acetate as a
      cervical preparation agent for second trimester surgical abortion. Specifically, this pilot
      study will test the feasibility of using ulipristal as a pharmacologic cervical preparation
      with adjunct misoprostol prior to surgical abortion.
Second trimester abortion comprises <10% of all induced abortions in the United States but
      there is still an important need to provide this service to women. Prior to dilation and
      evacuation (D&E), adequate preparation of the uterine cervix is an important part of
      preventing complications of the procedure. Commonly, this is done using osmotic dilators that
      are placed into the uterine cervix but cervical preparation can also be achieved using
      medications alone. Mifepristone is commonly used for this purpose but its use is regulated
      and often restricted due to the REMS (Risk Evaluation and Mitigation Strategy) program. The
      objective of this pilot study is to test the feasibility of using ulipristal, an oral
      medication similar to Mifepristone, as a medical form of cervical preparation prior to
      surgical abortion.This is a prospective cohort study investigating the use of ulipristal
      acetate (UPA) for pharmacologic cervical preparation with adjunct misoprostol prior to second
      trimester surgical abortion among women who are 16 to 18 6/7 weeks gestational age. Due the
      mechanism of action of UPA as a selective progesterone receptor modulator (SPRM) being
      similar to that of mifepristone, a medication known to be effective for cervical preparation,
      the investigators seek to describe the use of another SPRM for this same purpose. The
      investigators will conduct a pilot study assessing the feasibility of using UPA for cervical
      priming and report descriptive measures of its use. Per clinic protocols, patients over
      16-weeks gestation attend a consult and cervical preparation appointment the day prior to
      their procedure. Eligible patients will be offered enrollment. Subjects will receive UPA 90mg
      one day prior to their procedure and no osmotic dilators. All subjects will receive
      pre-procedure misoprostol (600mcg 90 minutes prior to procedure). The investigators will
      observe patients through their planned procedure and report descriptive measures of its use.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Adequacy of cervical dilation
time frame: Intraoperative
description: Ease of dilation, measured by visual analog score (0-100mm, 0 being "very easy" and 100 being "very difficult"
measure: Need for additional mechanical dilation
time frame: Intraoperative: start of dilation to completion of dilation
description: Number of dilator increments in French required to dilate the internal os
measure: Total procedure time
time frame: Intraoperative: from speculum placement to speculum removal
description: Minutes
measure: Total operative time
time frame: Intraoperative: insertion of the first instrument to removal of the last instrument from the uterus
description: Minutes
measure: Complications
time frame: Intraoperative and postoperative through 8-weeks
description: Number of cervical lacerations, uterine perforation, hemorrhage and need for transfer to high level of care
measure: Overall Pain Experienced
time frame: 20-minutes postoperative
description: 0-100mm on visual analog scale
measure: Number of procedures completed as scheduled
time frame: Time from enrollment to completion of procedure
arm group label: Ulipristal Acetate
arm group type: Experimental
description: Participants will be administered a one time dose of 90mg ulipristal acetate 18-24-hours prior to dilation and evacuation (surgical abortion) for cervical preparation.
intervention type: Drug
intervention name: Ulipristal Acetate
description: 90mg Ulipristal Acetate 18-24-hours prior to dilation and evacuation
arm group label: Ulipristal Acetate
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Principal Investigator, MD
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Ulipristal acetate
sharing ipd: No
ipd description: Will assess IPD sharing upon request.