<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/NCT02235181</url>
  </required_header>
  <id_info>
    <org_study_id>STOPPIT-2</org_study_id>
    <nct_id>NCT02235181</nct_id>
  </id_info>
  <brief_title>An Open Randomised Trial of the Arabin Pessary to Prevent Pre-term Birth in Twin Pregnancy</brief_title>
  <acronym>STOPPIT-2</acronym>
  <official_title>An Open Randomised Trial of the Arabin Pessary to Prevent Pre-term Birth in Twin Pregnancy in Woman With a Short Cervix (STOPPIT-2)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Edinburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>NHS Lothian</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Edinburgh</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to determine whether the Arabin cervical pessary prevents preterm birth in&#xD;
      women with a twin pregnancy and a short cervix.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      STOPPIT-2 is a multicentre open label randomised controlled trial of the Arabin pessary (CE&#xD;
      marked Device) versus Standard treatment in women with twin pregnancy. The study is in two&#xD;
      phases - a SCREENING phase, in which women with a short cervix (cervical length of ( less or&#xD;
      equal to 35mm) will be identified, and a TREATMENT phase, in which women with a short cervix&#xD;
      will be randomised to treatment with Arabin pessary or Standard treatment. Women will be seen&#xD;
      in the antenatal clinic setting.&#xD;
&#xD;
      An internal pilot phase will take place, with ten interviews being conducted with pregnant&#xD;
      women to explore the acceptability of proposed methods of recruitment, their information&#xD;
      requirements, their views of the consent and randomisation processes, and the delivery of the&#xD;
      intervention, including the screening component. The interviews will also explore their&#xD;
      understanding and expectations of trial participation. The findings of this pilot phase will&#xD;
      feed into the next phase of the trial and support the design of the interview guides for the&#xD;
      main nested qualitative study.&#xD;
&#xD;
      This pilot phase is separate from the main study. Later on we will ask both women and&#xD;
      healthcare professionals about their experiences of the study, via questionnaires and&#xD;
      face-to-face interviews.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2014</start_date>
  <completion_date type="Actual">October 31, 2019</completion_date>
  <primary_completion_date type="Actual">July 31, 2019</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Arabin cervical pessary reduces spontaneous preterm labour leading to preterm birth</measure>
    <time_frame>Delivery of the babies</time_frame>
    <description>Gestation at delivery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neonatal Outcomes</measure>
    <time_frame>within 4 weeks after expected date of delivery</time_frame>
    <description>The investigators will collect a number of measures to ascertain neonatal well being.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The profile of cervical length measurements in women with twin pregnancy in the UK</measure>
    <time_frame>18-20 weeks gestation</time_frame>
    <description>Cervical length</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant Satisfaction</measure>
    <time_frame>36 weeks gestation</time_frame>
    <description>Acceptability questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health economics</measure>
    <time_frame>18-20 weeks gestation until 4 weeks postnatal</time_frame>
    <description>cumulative hospital costs</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2228</enrollment>
  <condition>Twin Pregnancy With Antenatal Problem</condition>
  <arm_group>
    <arm_group_label>Standard Treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Women will be allocated to standard treatment, currently this is no treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arabin pessary</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Arabin cervical pessary will be inserted between 18 and 20+6 days gestation and removed between 35 and 36+6 weeks gestation unless Labour occurs sooner.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Arabin Cervical Pessary</intervention_name>
    <description>The Arabin pessary is CE-certified for preventing Spontaneous Preterm Birth (SPB) (CE 0482 / EN ISO 13485: 2003 annex III of the council directive 93/42 EEC) and is being used in this study as per the CE certification and manufacturer's guidance.</description>
    <arm_group_label>Arabin pessary</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women presenting with twin pregnancy (monochorionic or dichorionic)&#xD;
&#xD;
          -  Women with gestation established by scan at ≤16 weeks according to NICE guidelines.&#xD;
&#xD;
          -  Women aged 16 years or older&#xD;
&#xD;
          -  Women wishing to participate in both the SCREENING and RANDOMISATION phase of the&#xD;
             study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women unable to give written informed consent&#xD;
&#xD;
          -  Women with known significant congenital structural or chromosomal fetal anomaly at the&#xD;
             time of inclusion&#xD;
&#xD;
          -  Women with existing or planned cervical cerclage in the current pregnancy&#xD;
&#xD;
          -  Women who with existing or planned (prior to 20+6 weeks gestation) treatment for twin&#xD;
             to twin transfusion syndrome in the current pregnancy&#xD;
&#xD;
          -  Women with suspected or proven rupture of the fetal membranes at the time of&#xD;
             recruitment&#xD;
&#xD;
          -  Women with singleton pregnancy or higher order multiple pregnancies&#xD;
&#xD;
          -  Women with known sensitivity, contraindication or intolerance to silicone&#xD;
&#xD;
          -  Women involved in a clinical trial of an investigational medicinal product (CTIMP)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jane E Norman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Edinburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Countess of Chester</name>
      <address>
        <city>Chester</city>
        <state>Cheshire</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Mary's Hospital</name>
      <address>
        <city>Manchester</city>
        <state>Cheshire</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chesterfield Royal Hospital</name>
      <address>
        <city>Chesterfield</city>
        <state>Derbyshire</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Derriford Hospital</name>
      <address>
        <city>Plymouth</city>
        <state>Devon</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Poole Hospital</name>
      <address>
        <city>Poole</city>
        <state>Dorset</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Basildon hospital</name>
      <address>
        <city>Basildon</city>
        <state>Essex</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hillingdon Hospital</name>
      <address>
        <city>Uxbridge</city>
        <state>Greater London</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Bolton Hospital</name>
      <address>
        <city>Bolton</city>
        <state>Lancashire</state>
        <zip>BL4 0JR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Preston Hospital</name>
      <address>
        <city>Preston</city>
        <state>Lancashire</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Croydon hospital</name>
      <address>
        <city>Croydon</city>
        <state>London</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Simpson Centre for Reproductive Health, Royal Infirmary Hospital, Edinburgh</name>
      <address>
        <city>Edinburgh</city>
        <state>Lothian</state>
        <zip>EH16 4SA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pinderfields Hospital</name>
      <address>
        <city>Wakefield</city>
        <state>Mid Yorkshire</state>
        <zip>WF1 4DG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Victoria Hospital</name>
      <address>
        <city>Newcastle Upon Tyne</city>
        <state>North East</state>
        <zip>NE1 4LP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wansbeck General Hospital</name>
      <address>
        <city>Ashington</city>
        <state>Northumbria</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Tyneside General Hospital</name>
      <address>
        <city>North Shields</city>
        <state>Northumbria</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Helier Hospital</name>
      <address>
        <city>Carshalton</city>
        <state>Surrey</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Epsom Hospital</name>
      <address>
        <city>Epsom</city>
        <state>Surrey</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>George Eliot</name>
      <address>
        <city>Nuneaton</city>
        <state>Warwickshire</state>
        <zip>CV10 7DJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Birmingham Womens Hospital</name>
      <address>
        <city>Birmingham</city>
        <state>West Midlands</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Russells Hall Hospital</name>
      <address>
        <city>Dudley</city>
        <state>West Midlands</state>
        <zip>DY1 2HQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bradford Royal Infirmary</name>
      <address>
        <city>Bradford</city>
        <state>Yorkshire</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leeds University Hospital Trust</name>
      <address>
        <city>Leeds</city>
        <state>Yorkshire</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aberdeen Maternity Hospital</name>
      <address>
        <city>Aberdeen</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Birmingham Heartlands Hospital</name>
      <address>
        <city>Birmingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lancashire Women's and Newborn Centre</name>
      <address>
        <city>Burnley</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rosie Maternity Hospital</name>
      <address>
        <city>Cambridge</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leighton Hospital</name>
      <address>
        <city>Crewe</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Devon &amp; Exeter</name>
      <address>
        <city>Exeter</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth Hospital</name>
      <address>
        <city>Gateshead</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Royal Maternity Hospital</name>
      <address>
        <city>Glasgow</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth University Hospital</name>
      <address>
        <city>Glasgow</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arrowe Park Hospital, Wirral</name>
      <address>
        <city>Liverpool</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liverpool Women's Hospital</name>
      <address>
        <city>Liverpool</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Whiston Hospital</name>
      <address>
        <city>Liverpool</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Johns Hospital</name>
      <address>
        <city>Livingston</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Homerton University Hospital NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Newham Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Charlottes' Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal London Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Georges Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Thomas Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Mary's</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University College Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Whipps Cross Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>James Cook Hospital</name>
      <address>
        <city>Middlesborough</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Norfolk and Norwich Hospital</name>
      <address>
        <city>Norwich</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Hospital NUH NHS Trust</name>
      <address>
        <city>Nottingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queens Medical Centre, NUH NHS Trust</name>
      <address>
        <city>Nottingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Salisbury District Hospital</name>
      <address>
        <city>Salisbury</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jessop Wing, Sheffield Teaching Hospitals NHS FT</name>
      <address>
        <city>Sheffield</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Anne Hospital</name>
      <address>
        <city>Southampton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Stoke University Hospital University Hospitals of North Midlands</name>
      <address>
        <city>Stoke</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunderland Royal Hospital</name>
      <address>
        <city>Sunderland</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Cornwall</name>
      <address>
        <city>Truro</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Cross Hospital</name>
      <address>
        <city>Wolverhampton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wrexham Maelor</name>
      <address>
        <city>Wrexham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://w3.abdn.ac.uk/hsru/STOPPIT2/</url>
    <description>STOPPIT2 Study page</description>
  </link>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>March 24, 2020</last_update_submitted>
  <last_update_submitted_qc>March 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Twin Pregnancy</keyword>
  <keyword>Prevention of Preterm birth</keyword>
  <keyword>Short Cervix</keyword>
  <keyword>Arabin cervical pessary</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>to be confirmed</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/NCT02235181
org study id: STOPPIT-2
nct id: NCT02235181
lead sponsor: 
collaborator: 
has dmc: Yes
This study aims to determine whether the Arabin cervical pessary prevents preterm birth in
      women with a twin pregnancy and a short cervix.
STOPPIT-2 is a multicentre open label randomised controlled trial of the Arabin pessary (CE
      marked Device) versus Standard treatment in women with twin pregnancy. The study is in two
      phases - a SCREENING phase, in which women with a short cervix (cervical length of ( less or
      equal to 35mm) will be identified, and a TREATMENT phase, in which women with a short cervix
      will be randomised to treatment with Arabin pessary or Standard treatment. Women will be seen
      in the antenatal clinic setting.

      An internal pilot phase will take place, with ten interviews being conducted with pregnant
      women to explore the acceptability of proposed methods of recruitment, their information
      requirements, their views of the consent and randomisation processes, and the delivery of the
      intervention, including the screening component. The interviews will also explore their
      understanding and expectations of trial participation. The findings of this pilot phase will
      feed into the next phase of the trial and support the design of the interview guides for the
      main nested qualitative study.

      This pilot phase is separate from the main study. Later on we will ask both women and
      healthcare professionals about their experiences of the study, via questionnaires and
      face-to-face interviews.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: The Arabin cervical pessary reduces spontaneous preterm labour leading to preterm birth
time frame: Delivery of the babies
description: Gestation at delivery
measure: Neonatal Outcomes
time frame: within 4 weeks after expected date of delivery
description: The investigators will collect a number of measures to ascertain neonatal well being.
measure: The profile of cervical length measurements in women with twin pregnancy in the UK
time frame: 18-20 weeks gestation
description: Cervical length
measure: Participant Satisfaction
time frame: 36 weeks gestation
description: Acceptability questionnaire
measure: Health economics
time frame: 18-20 weeks gestation until 4 weeks postnatal
description: cumulative hospital costs
arm group label: Standard Treatment
arm group type: No Intervention
description: Women will be allocated to standard treatment, currently this is no treatment.
arm group label: Arabin pessary
arm group type: Active Comparator
description: The Arabin cervical pessary will be inserted between 18 and 20+6 days gestation and removed between 35 and 36+6 weeks gestation unless Labour occurs sooner.
intervention type: Device
intervention name: Arabin Cervical Pessary
description: The Arabin pessary is CE-certified for preventing Spontaneous Preterm Birth (SPB) (CE 0482 / EN ISO 13485: 2003 annex III of the council directive 93/42 EEC) and is being used in this study as per the CE certification and manufacturer's guidance.
arm group label: Arabin pessary
criteria: 
gender: Female
minimum age: 16 Years
maximum age: 60 Years
healthy volunteers: No
last name: Jane E Norman, MD
role: Principal Investigator
affiliation: University of Edinburgh
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country: Belgium
country: United Kingdom
url: https://w3.abdn.ac.uk/hsru/STOPPIT2/
description: STOPPIT2 Study page
responsible party type: Sponsor
mesh term: Premature Birth
sharing ipd: Yes
ipd description: to be confirmed