<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/NCT01678703</url>
  </required_header>
  <id_info>
    <org_study_id>2trimabort.CTIL</org_study_id>
    <nct_id>NCT01678703</nct_id>
  </id_info>
  <brief_title>Comparison of Laminaria and Misoprostol for Cervical Preparation Before Second Trimester Surgical Abortion</brief_title>
  <official_title>Randomized Controlled Study: Comparison of Laminaria and Misoprostol for Cervical Preparation Before Second Trimester Surgical Abortion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wolfson Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wolfson Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study compares the effectiveness of cervical preparation before second trimester&#xD;
      abortion using laminaria versus vaginal Misoprostol.&#xD;
&#xD;
      The investigators hypothesize that medical preparation of the cervix with vaginal Misoprostol&#xD;
      is superior to mechanical preparation using laminaria.&#xD;
&#xD;
      The investigators believe that medical preparation makes the procedure easier to perform,&#xD;
      equally safe, without addition of pain or discomfort.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective randomized study.&#xD;
&#xD;
      The aim of the study is to compare preparation of the cervix before surgical abortion with&#xD;
      laminaria and misoprostol.&#xD;
&#xD;
      Primary outcome measures will include:&#xD;
&#xD;
      Initial cervical opening and the need for further dilatation at the procedure Procedure&#xD;
      duration&#xD;
&#xD;
      Difficulty score performing the abortion&#xD;
&#xD;
      Complications during and after the procedure&#xD;
&#xD;
      Assessment of pain, using VAS scale, and the need for analgesia before and after the&#xD;
      procedure&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2007</start_date>
  <completion_date type="Actual">June 2010</completion_date>
  <primary_completion_date type="Actual">June 2010</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Initial cervical opening and the need for further dilatation at the start of the procedure</measure>
    <time_frame>8-12 hours after insersion of laminaria or Misoprostol</time_frame>
    <description>The surgical abortion will be performed 8-12 hours after the insertion of laminaria, or after vaginal application of Misoprostol</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>pain score during cervical preparation and after the procedure</measure>
    <time_frame>at the time of the insertion, immediately before the abortion and immediately upon recovery from anesthesia</time_frame>
    <description>The pain score will be accessed immediately after the insertion of the laminaria or the vaginal Misoprostol.&#xD;
Pain score will be recorded again right before performing the abortion and will address the 8-12 hours elapsed from the insertion.&#xD;
Another assessment of pain will be recorded immediately after the abortion following recovery from general anesthesia</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The degree of difficulty to accomplish the abortion</measure>
    <time_frame>at the time of performing the surgical abortion</time_frame>
    <description>The difficulty score will be recorded by the surgeon at the operating room immediately upon completion of the procedure.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">84</enrollment>
  <condition>Induced; Abortion, Nonmedical</condition>
  <arm_group>
    <arm_group_label>Laminaria group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this group will have cervical preparation with laminaria MedGyn Products, Inc. USA overnight the day before the abortion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Misoprostol group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this group will have cervical preparation with vaginal Misoprostol 600 mcg overnight the day before the abortion</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Laminaria, MedGyn Products, Inc. USA.</intervention_name>
    <description>Insertion of Hygroscopic laminarias into the cervical canal for preparation prior to late surgical abortion. The number of laminarias is according to the cervical compliance.</description>
    <arm_group_label>Laminaria group</arm_group_label>
    <other_name>laminaria tents</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Misoprostol</intervention_name>
    <description>Cervical preparation with vaginal Misoprostol 600 mcg overnight the day before the abortion</description>
    <arm_group_label>Misoprostol group</arm_group_label>
    <other_name>Cytotec</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant patients with a viable singleton&#xD;
&#xD;
          -  Pregnancy 14-20 weeks of gestation&#xD;
&#xD;
          -  Admitted for termination of pregnancy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication for administration of Misoprostol&#xD;
&#xD;
          -  Patients with more than one previous cesarean section scar&#xD;
&#xD;
          -  Patients with impaired coagulation&#xD;
&#xD;
          -  Significant pulmonary or cardiac disease&#xD;
&#xD;
          -  Non viable pregnancy&#xD;
&#xD;
          -  Placenta accreta or previa by ultrasound&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ron Sagiv, MD</last_name>
    <role>Study Director</role>
    <affiliation>Tel Aviv University, Sackler Medical School, Israel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Edith Wolfson Medical Center</name>
      <address>
        <city>Holon</city>
        <zip>58100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>July 2012</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <last_update_submitted>August 30, 2012</last_update_submitted>
  <last_update_submitted_qc>August 30, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 5, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>late abortion</keyword>
  <keyword>laminaria</keyword>
  <keyword>Misoprostol</keyword>
  <keyword>Cervical preparation</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Misoprostol</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01678703
org study id: 2trimabort.CTIL
nct id: NCT01678703
lead sponsor: 
has dmc: Yes
This study compares the effectiveness of cervical preparation before second trimester
      abortion using laminaria versus vaginal Misoprostol.

      The investigators hypothesize that medical preparation of the cervix with vaginal Misoprostol
      is superior to mechanical preparation using laminaria.

      The investigators believe that medical preparation makes the procedure easier to perform,
      equally safe, without addition of pain or discomfort.
This is a prospective randomized study.

      The aim of the study is to compare preparation of the cervix before surgical abortion with
      laminaria and misoprostol.

      Primary outcome measures will include:

      Initial cervical opening and the need for further dilatation at the procedure Procedure
      duration

      Difficulty score performing the abortion

      Complications during and after the procedure

      Assessment of pain, using VAS scale, and the need for analgesia before and after the
      procedure
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Initial cervical opening and the need for further dilatation at the start of the procedure
time frame: 8-12 hours after insersion of laminaria or Misoprostol
description: The surgical abortion will be performed 8-12 hours after the insertion of laminaria, or after vaginal application of Misoprostol
measure: pain score during cervical preparation and after the procedure
time frame: at the time of the insertion, immediately before the abortion and immediately upon recovery from anesthesia
description: The pain score will be accessed immediately after the insertion of the laminaria or the vaginal Misoprostol.
Pain score will be recorded again right before performing the abortion and will address the 8-12 hours elapsed from the insertion.
Another assessment of pain will be recorded immediately after the abortion following recovery from general anesthesia
measure: The degree of difficulty to accomplish the abortion
time frame: at the time of performing the surgical abortion
description: The difficulty score will be recorded by the surgeon at the operating room immediately upon completion of the procedure.
arm group label: Laminaria group
arm group type: Active Comparator
description: Patients in this group will have cervical preparation with laminaria MedGyn Products, Inc. USA overnight the day before the abortion
arm group label: Misoprostol group
arm group type: Active Comparator
description: Patients in this group will have cervical preparation with vaginal Misoprostol 600 mcg overnight the day before the abortion
intervention type: Device
intervention name: Laminaria, MedGyn Products, Inc. USA.
description: Insertion of Hygroscopic laminarias into the cervical canal for preparation prior to late surgical abortion. The number of laminarias is according to the cervical compliance.
arm group label: Laminaria group
other name: laminaria tents
intervention type: Drug
intervention name: Misoprostol
description: Cervical preparation with vaginal Misoprostol 600 mcg overnight the day before the abortion
arm group label: Misoprostol group
other name: Cytotec
criteria: 
gender: Female
minimum age: 15 Years
maximum age: 45 Years
healthy volunteers: No
last name: Ron Sagiv, MD
role: Study Director
affiliation: Tel Aviv University, Sackler Medical School, Israel
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Misoprostol