<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/NCT02967445</url>
  </required_header>
  <id_info>
    <org_study_id>2156/15</org_study_id>
    <nct_id>NCT02967445</nct_id>
  </id_info>
  <brief_title>Physical Examination-Indicated Pessary</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federico II University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federico II University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cervical insufficiency, previously referred to as cervical incompetence, has classically been&#xD;
      defined as painless dilation of the cervix in the absence of contractions or bleeding in the&#xD;
      second trimester resulting in recurrent pregnancy losses. Painless mid-trimester cervical&#xD;
      dilation is an uncommon finding in the general population occurring in less than 1% of&#xD;
      pregnancies. Cerclage for the prevention pregnancy loss in cases with both prior preterm&#xD;
      births and/or second trimester losses, as well as second trimester cervical dilatation in the&#xD;
      index pregnancy, was first reported in the 1950's. Cerclage placement in this setting has&#xD;
      been variably referred to as &quot;physical exam-indicated cerclage&quot;, &quot;rescue cerclage&quot;, and&#xD;
      &quot;emergency cerclage&quot;. To date, the benefits of cerclage for this indication are not entirely&#xD;
      clear.&#xD;
&#xD;
      A recent meta-analysis showed that physical exam-indicated cerclage is associated with a&#xD;
      reduction in perinatal mortality and prolongation of pregnancy when compared to no such&#xD;
      cerclage.&#xD;
&#xD;
      Recently, several RCTs have shown that cervical pessary could decrease the incidence of PTB&#xD;
      in several populations.&#xD;
&#xD;
      Thus, the aim of our trial as noninferiority trial is to evaluate the efficacy of pessary&#xD;
      compared to cervical cerclage in prevention of PTB in women in the setting of mid-trimester&#xD;
      cervical dilation&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    never started&#xD;
  </why_stopped>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Anticipated">March 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>Phase 3</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>Neonatal survival</measure>
    <time_frame>From delivery to 28 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Preterm birth</measure>
    <time_frame>time of delivery</time_frame>
    <description>&lt;24, &lt;28, &lt;30 weeks. both spontaneous and indicated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Latency</measure>
    <time_frame>time of delivery</time_frame>
    <description>Time from randomization to delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Birth weight</measure>
    <time_frame>time of delivery</time_frame>
    <description>in grams</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>gestational age at delivery</measure>
    <time_frame>time of delivery</time_frame>
    <description>mean of delivery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>PreTerm Birth</condition>
  <arm_group>
    <arm_group_label>Cervical pessary</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arabin Pessary</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cervical cerclage</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>McDonald Cerclage</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Arabin Pessary</intervention_name>
    <description>Arabin silicon pessary</description>
    <arm_group_label>Cervical pessary</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cervical cerclage</intervention_name>
    <arm_group_label>Cervical cerclage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Singleton pregnancies&#xD;
&#xD;
          -  Cervical dilation between 1 to 5 cm and/or visible membranes by pelvic exam or&#xD;
             speculum exam between at 16-23 6/7 weeks gestation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pessary or cerclage already in situ&#xD;
&#xD;
          -  active vaginal bleeding&#xD;
&#xD;
          -  Placenta previa/accreta&#xD;
&#xD;
          -  Multiple gestations&#xD;
&#xD;
          -  Amniotic membranes prolapsed beyond external os into the vagina, unable to visualize&#xD;
             cervical tissue&#xD;
&#xD;
          -  Ruptured amniotic membranes at the time of diagnosis of dilated cervix&#xD;
&#xD;
          -  Cervical dilation more than 5 cm&#xD;
&#xD;
          -  Labor (progressing cervical dilation) or painful regular uterine contractions&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Gabriele Saccone</name>
      <address>
        <city>Napoli</city>
        <zip>80129</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 11, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>November 15, 2018</last_update_submitted>
  <last_update_submitted_qc>November 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federico II University</investigator_affiliation>
    <investigator_full_name>Gabriele Saccone</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
  </condition_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/NCT02967445
org study id: 2156/15
nct id: NCT02967445
lead sponsor: 
has dmc: No
Cervical insufficiency, previously referred to as cervical incompetence, has classically been
      defined as painless dilation of the cervix in the absence of contractions or bleeding in the
      second trimester resulting in recurrent pregnancy losses. Painless mid-trimester cervical
      dilation is an uncommon finding in the general population occurring in less than 1% of
      pregnancies. Cerclage for the prevention pregnancy loss in cases with both prior preterm
      births and/or second trimester losses, as well as second trimester cervical dilatation in the
      index pregnancy, was first reported in the 1950's. Cerclage placement in this setting has
      been variably referred to as "physical exam-indicated cerclage", "rescue cerclage", and
      "emergency cerclage". To date, the benefits of cerclage for this indication are not entirely
      clear.

      A recent meta-analysis showed that physical exam-indicated cerclage is associated with a
      reduction in perinatal mortality and prolongation of pregnancy when compared to no such
      cerclage.

      Recently, several RCTs have shown that cervical pessary could decrease the incidence of PTB
      in several populations.

      Thus, the aim of our trial as noninferiority trial is to evaluate the efficacy of pessary
      compared to cervical cerclage in prevention of PTB in women in the setting of mid-trimester
      cervical dilation
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Neonatal survival
time frame: From delivery to 28 days
measure: Preterm birth
time frame: time of delivery
description: <24, <28, <30 weeks. both spontaneous and indicated
measure: Latency
time frame: time of delivery
description: Time from randomization to delivery
measure: Birth weight
time frame: time of delivery
description: in grams
measure: gestational age at delivery
time frame: time of delivery
description: mean of delivery
arm group label: Cervical pessary
arm group type: Experimental
description: Arabin Pessary
arm group label: Cervical cerclage
arm group type: Active Comparator
description: McDonald Cerclage
intervention type: Device
intervention name: Arabin Pessary
description: Arabin silicon pessary
arm group label: Cervical pessary
intervention type: Device
intervention name: Cervical cerclage
arm group label: Cervical cerclage
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Federico II University
investigator full name: Gabriele Saccone
investigator title: MD
mesh term: Premature Birth