xml: <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/NCT05981469</url>
    </required_header>
    <id_info>
      <org_study_id>UoL001713</org_study_id>
      <nct_id>NCT05981469</nct_id>
    </id_info>
    <brief_title>Can Cervical Stiffness Predict Successful Vaginal Delivery After Induction of Labour?</brief_title>
    <acronym>CASPAR</acronym>
    <official_title>Can Cervical Stiffness Predict Successful Vaginal Delivery After Induction of Labour?</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Liverpool</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Liverpool Women's NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Liverpool</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to determine if a new antenatal test of cervical stiffness can&#xD;
        be used to predict which patients will have a successful vaginal delivery following an&#xD;
        induction of labour.&#xD;
  &#xD;
        A licensed, CE-marked, vacuum-aspiration device called the Pregnolia system has been&#xD;
        developed to give quantitative cervical stiffness index score during pregnancy. The CASPAR&#xD;
        study will compare cervical stiffness scores to bishop's scores prior to induction of labour&#xD;
        and correlate the results to the outcome of delivery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        CASPAR is a single site prospective, exploratory, cohort study of 100 women with singleton&#xD;
        pregnancy undergoing induction of labour at the Liverpool Women's Hospital (LWH).&#xD;
  &#xD;
        All eligible participants giving written informed consent will be asked to undergo a sterile&#xD;
        speculum examination for cervical stiffness assessment, prior to routine vaginal digital&#xD;
        examination for Bishop's score assessment. Participants will then proceed with their&#xD;
        induction of labour as per the unit policy.&#xD;
  &#xD;
        Once recruited the participants will remain in the study until after delivery and discharge&#xD;
        from hospital for the mother and baby, or 1 month after delivery, whichever comes first.&#xD;
        Outcomes will be collected from electronic records.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 25, 2023</start_date>
    <completion_date type="Anticipated">May 3, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 4, 2024</primary_completion_date>
    <study_type>Observational</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>
    <primary_outcome>
      <measure>Number of participants with Vaginal Delivery</measure>
      <time_frame>5 days (time of commencing induction of labour to outcome of delivery)</time_frame>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Induced Vaginal Delivery</condition>
    <arm_group>
      <arm_group_label>Induction of labour</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Cervical Stiffness Assessmenr</intervention_name>
      <description>The cervical stiffness is assessed by using the licensed, CE-marked Pregnolia System, during a sterile speculum examination. The single-use, sterile Pregnolia Probe is placed on the anterior lip of the cervix at 12 o'clock position and a recording of cervical stiffness is generated over maximum 60 seconds (typically ̴15 seconds) and displayed as Cervical Stiffness Index (CSI) in mbar. The measurement is repeated 3 consecutive times without any time lag.</description>
      <arm_group_label>Induction of labour</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Bishop's Score Assessment</intervention_name>
      <description>Sterile digital vaginal examination to illicit the Bishop's score (0-12).</description>
      <arm_group_label>Induction of labour</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Participants with singleton, term pregnancy, requiring induction of labour.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 18 years&#xD;
  &#xD;
            -  Being induced&#xD;
  &#xD;
            -  Singleton pregnancy&#xD;
  &#xD;
            -  Primiparous&#xD;
  &#xD;
            -  ≥37+0 weeks gestation&#xD;
  &#xD;
            -  Intact membranes&#xD;
  &#xD;
            -  Able to provide informed consent&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            -  Previous cervical surgery&#xD;
  &#xD;
            -  Any cervical pathology at 12 o'clock position on cervix&#xD;
  &#xD;
            -  Vaginal bleeding evident on examination&#xD;
  &#xD;
            -  Visible, symptomatic cervical or vaginal infections&#xD;
  &#xD;
            -  Known congenital uterine anomalies&#xD;
  &#xD;
            -  Known or suspected structural/chromosomal fetal abnormality&#xD;
  &#xD;
            -  Known HIV&#xD;
  &#xD;
            -  Cervical carcinoma&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Female of reproductive age with confirmed singleton pregnancy.</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Andrew Sharp</last_name>
      <role>Study Director</role>
      <affiliation>University of Liverpool</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Elizabeth Medford, MBChB, MRCOG</last_name>
      <phone>01517089988</phone>
      <email>elizabeth.medford1@lwh.nhs.uk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Angharad Care, MBBS, BSc, PhD</last_name>
      <phone>01517089988</phone>
      <email>acare84@liverpool.ac.uk</email>
    </overall_contact_backup>
    <link>
      <url>http://en.pregnolia.com/</url>
      <description>Cervical stiffness assessment device website Available IPD/Information:</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>cervical stiffness</keyword>
    <keyword>induction of labour</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05981469
  org study id: UoL001713
  nct id: NCT05981469
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to determine if a new antenatal test of cervical stiffness can
        be used to predict which patients will have a successful vaginal delivery following an
        induction of labour.
  
        A licensed, CE-marked, vacuum-aspiration device called the Pregnolia system has been
        developed to give quantitative cervical stiffness index score during pregnancy. The CASPAR
        study will compare cervical stiffness scores to bishop's scores prior to induction of labour
        and correlate the results to the outcome of delivery.
  CASPAR is a single site prospective, exploratory, cohort study of 100 women with singleton
        pregnancy undergoing induction of labour at the Liverpool Women's Hospital (LWH).
  
        All eligible participants giving written informed consent will be asked to undergo a sterile
        speculum examination for cervical stiffness assessment, prior to routine vaginal digital
        examination for Bishop's score assessment. Participants will then proceed with their
        induction of labour as per the unit policy.
  
        Once recruited the participants will remain in the study until after delivery and discharge
        from hospital for the mother and baby, or 1 month after delivery, whichever comes first.
        Outcomes will be collected from electronic records.
  observational model: Cohort
  time perspective: Prospective
  measure: Number of participants with Vaginal Delivery
  time frame: 5 days (time of commencing induction of labour to outcome of delivery)
  arm group label: Induction of labour
  intervention type: Device
  intervention name: Cervical Stiffness Assessmenr
  description: The cervical stiffness is assessed by using the licensed, CE-marked Pregnolia System, during a sterile speculum examination. The single-use, sterile Pregnolia Probe is placed on the anterior lip of the cervix at 12 o'clock position and a recording of cervical stiffness is generated over maximum 60 seconds (typically ̴15 seconds) and displayed as Cervical Stiffness Index (CSI) in mbar. The measurement is repeated 3 consecutive times without any time lag.
  arm group label: Induction of labour
  intervention type: Other
  intervention name: Bishop's Score Assessment
  description: Sterile digital vaginal examination to illicit the Bishop's score (0-12).
  arm group label: Induction of labour
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Female of reproductive age with confirmed singleton pregnancy.
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Andrew Sharp
  role: Study Director
  affiliation: University of Liverpool
  last name: Elizabeth Medford, MBChB, MRCOG
  phone: 01517089988
  email: elizabeth.medford1@lwh.nhs.uk
  last name: Angharad Care, MBBS, BSc, PhD
  phone: 01517089988
  email: acare84@liverpool.ac.uk
  url: http://en.pregnolia.com/
  description: Cervical stiffness assessment device website Available IPD/Information:
  responsible party type: Sponsor
  sharing ipd: No