<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/NCT02242214</url>
  </required_header>
  <id_info>
    <org_study_id>000188</org_study_id>
    <nct_id>NCT02242214</nct_id>
  </id_info>
  <brief_title>REgistry of MisOprostol 200 µg Vaginal dElivery System</brief_title>
  <acronym>REMOVE</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>Ferring Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ferring Pharmaceuticals</source>
  <brief_summary>
    <textblock>
      The design of the study is post-marketing, observational, multi-centre and open-label. The&#xD;
      study does not provide treatment; only patients to whom misoprostol 200 µg vaginal delivery&#xD;
      system (VDS) is prescribed may be included. All directions for medication usage and patient&#xD;
      monitoring are solely at the discretion of the investigator in accordance with their usual&#xD;
      practice and must be consistent with the Dutch prescribing information of misoprostol 200 µg&#xD;
      VDS. No other (invasive) study-related interventions or measurements are done, other than the&#xD;
      procedures routinely performed during induction of labour. No effort is expected from the&#xD;
      study subjects. 150 patients from 20 Dutch centres will be included.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Days</target_duration>
  <primary_outcome>
    <measure>Time to vaginal delivery of the neonate in hours</measure>
    <time_frame>From insertion until vaginal delivery</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">106</enrollment>
  <condition>Induction of Labour</condition>
  <arm_group>
    <arm_group_label>Misoprostol 200 µg VDS</arm_group_label>
    <description>At the discretion of the investigator in accordance with their usual practice and consistent with the Dutch prescribing information.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Misoprostol</intervention_name>
    <arm_group_label>Misoprostol 200 µg VDS</arm_group_label>
    <other_name>Misodel®</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Academic and peripheral hospitals in the Netherlands&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of induction of labour in women with an unfavourable cervix, from 36 weeks&#xD;
             gestation, in whom induction is clinically indicated&#xD;
&#xD;
          -  Decision made to prescribe misoprostol 200 µg VDS according to Summary of Product&#xD;
             Characteristics (SmPC)&#xD;
&#xD;
          -  Willingness and ability to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Misoprostol 200 µg VDS is contraindicated according to the SmPC&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Development Support</last_name>
    <role>Study Director</role>
    <affiliation>Ferring Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Isala Klinieken (there may be other sites in this country)</name>
      <address>
        <city>Zwolle</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>September 12, 2014</study_first_submitted>
  <study_first_submitted_qc>September 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <last_update_submitted>September 15, 2015</last_update_submitted>
  <last_update_submitted_qc>September 15, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 16, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT02242214
org study id: 000188
nct id: NCT02242214
lead sponsor: 
The design of the study is post-marketing, observational, multi-centre and open-label. The
      study does not provide treatment; only patients to whom misoprostol 200 µg vaginal delivery
      system (VDS) is prescribed may be included. All directions for medication usage and patient
      monitoring are solely at the discretion of the investigator in accordance with their usual
      practice and must be consistent with the Dutch prescribing information of misoprostol 200 µg
      VDS. No other (invasive) study-related interventions or measurements are done, other than the
      procedures routinely performed during induction of labour. No effort is expected from the
      study subjects. 150 patients from 20 Dutch centres will be included.
observational model: Cohort
time perspective: Prospective
measure: Time to vaginal delivery of the neonate in hours
time frame: From insertion until vaginal delivery
arm group label: Misoprostol 200 µg VDS
description: At the discretion of the investigator in accordance with their usual practice and consistent with the Dutch prescribing information.
intervention type: Drug
intervention name: Misoprostol
arm group label: Misoprostol 200 µg VDS
other name: Misodel®
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Clinical Development Support
role: Study Director
affiliation: Ferring Pharmaceuticals
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Misoprostol