<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/NCT03016208</url>
  </required_header>
  <id_info>
    <org_study_id>Miso2017</org_study_id>
    <nct_id>NCT03016208</nct_id>
  </id_info>
  <brief_title>The Misoprostol Vaginal Insert for Labour Induction</brief_title>
  <official_title>The Misoprostol Vaginal Insert Used in Standard Compared With Adjusted Criteria for Labour Induction in Term Pregnancies: a Non-interventional Case Control Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asklepios Kliniken Hamburg GmbH</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Asklepios Kliniken Hamburg GmbH</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objective: To compare the efficacy and safety of the misoprostol vaginal insert (MVI) for&#xD;
      labour induction using standard (MVI-24) and adjusted (MVI-10) criteria.&#xD;
&#xD;
      Design: Non-interventional observational case control study.&#xD;
&#xD;
      Setting: Tertiary-care academic centre in Germany.&#xD;
&#xD;
      Population: A cohort of 138 pregnant women ≥ 37/0 weeks undergoing labour induction.&#xD;
&#xD;
      Methods: Induction of labour with MVI in a consecutive series of women using standard&#xD;
      (MVI-24, n = 69) or adjusted (MVI-10, n = 69) criteria.&#xD;
&#xD;
      Main outcome measures: The primary outcomes were the time from induction to delivery and the&#xD;
      caesarean section rate. The secondary outcomes included the need for additional measures to&#xD;
      induce labour, uterine tachysystole, tocolysis, fetal scalp blood testing, meconium-stained&#xD;
      amniotic fluid, umbilical arterial pH, and Apgar score.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2015</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
  </study_design_info>
  <primary_outcome>
    <measure>Time from induction to delivery in minutes</measure>
    <time_frame>August 2016</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of participants receiving a caesarean section compared to all participants being induced</measure>
    <time_frame>August 2016</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with treatment-related tachysystole as assessed by cardiotocography</measure>
    <time_frame>August 2016</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with treatment-related adverse events following tocolysis with Partusisten</measure>
    <time_frame>August 2016</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with fetal compromise assessed by the APGAR-Score and the postpartum fetal pH-value</measure>
    <time_frame>August 2016</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">138</enrollment>
  <condition>Labour Induction</condition>
  <arm_group>
    <arm_group_label>Misoprostol vaginal insert for max. 24hrs</arm_group_label>
    <description>69 patients matching the inclusion criteria and received MVI for labour induction for a maximum of 24 hours</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Misoprostol vaginal insert for max. 10hrs</arm_group_label>
    <description>69 patients matching the inclusion criteria and received MVI for labour induction for a maximum of 10 hours</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Misoprostol vaginal insert</intervention_name>
    <arm_group_label>Misoprostol vaginal insert for max. 10hrs</arm_group_label>
    <arm_group_label>Misoprostol vaginal insert for max. 24hrs</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A cohort of 138 pregnant women ≥ 37/0 weeks undergoing labour induction.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  gynecologist's indication for induction&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
          -  ≥ 37 weeks of gestation&#xD;
&#xD;
          -  singleton pregnancies&#xD;
&#xD;
          -  cephalic presentation&#xD;
&#xD;
          -  cervical Bishop score of &lt; 5 before priming reassuring fetal heart rate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known hypersensitivity to prostaglandins&#xD;
&#xD;
          -  uterine scar&#xD;
&#xD;
          -  parity &gt; 5&#xD;
&#xD;
          -  any contraindication for vaginal delivery&#xD;
&#xD;
          -  cephalopelvic disproportion&#xD;
&#xD;
          -  placenta praevia&#xD;
&#xD;
          -  chorioamnionitis&#xD;
&#xD;
          -  antepartum bleeding of unknown etiology&#xD;
&#xD;
          -  cardiopulmonary, renal, hepatic maternal disease&#xD;
&#xD;
          -  glaucoma&#xD;
&#xD;
          -  fetal congenital abnormalities&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 8, 2017</study_first_submitted>
  <study_first_submitted_qc>January 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>January 9, 2017</last_update_submitted>
  <last_update_submitted_qc>January 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Asklepios Kliniken Hamburg GmbH</investigator_affiliation>
    <investigator_full_name>Peter Schwaerzler</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Misoprostol</mesh_term>
  </intervention_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/NCT03016208
org study id: Miso2017
nct id: NCT03016208
lead sponsor: 
has dmc: No
Objective: To compare the efficacy and safety of the misoprostol vaginal insert (MVI) for
      labour induction using standard (MVI-24) and adjusted (MVI-10) criteria.

      Design: Non-interventional observational case control study.

      Setting: Tertiary-care academic centre in Germany.

      Population: A cohort of 138 pregnant women ≥ 37/0 weeks undergoing labour induction.

      Methods: Induction of labour with MVI in a consecutive series of women using standard
      (MVI-24, n = 69) or adjusted (MVI-10, n = 69) criteria.

      Main outcome measures: The primary outcomes were the time from induction to delivery and the
      caesarean section rate. The secondary outcomes included the need for additional measures to
      induce labour, uterine tachysystole, tocolysis, fetal scalp blood testing, meconium-stained
      amniotic fluid, umbilical arterial pH, and Apgar score.
observational model: Cohort
measure: Time from induction to delivery in minutes
time frame: August 2016
measure: Rate of participants receiving a caesarean section compared to all participants being induced
time frame: August 2016
measure: Number of participants with treatment-related tachysystole as assessed by cardiotocography
time frame: August 2016
measure: Number of participants with treatment-related adverse events following tocolysis with Partusisten
time frame: August 2016
measure: Number of participants with fetal compromise assessed by the APGAR-Score and the postpartum fetal pH-value
time frame: August 2016
arm group label: Misoprostol vaginal insert for max. 24hrs
description: 69 patients matching the inclusion criteria and received MVI for labour induction for a maximum of 24 hours
arm group label: Misoprostol vaginal insert for max. 10hrs
description: 69 patients matching the inclusion criteria and received MVI for labour induction for a maximum of 10 hours
intervention type: Drug
intervention name: Misoprostol vaginal insert
arm group label: Misoprostol vaginal insert for max. 10hrs
arm group label: Misoprostol vaginal insert for max. 24hrs
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Asklepios Kliniken Hamburg GmbH
investigator full name: Peter Schwaerzler
investigator title: Principal investigator
mesh term: Misoprostol
sharing ipd: No