<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/NCT04444206</url>
  </required_header>
  <id_info>
    <org_study_id>8451</org_study_id>
    <nct_id>NCT04444206</nct_id>
  </id_info>
  <brief_title>Prevention of Preterm Birth by Screening of the Consistency Index and Length of the Uterine Cervix in Women With a Single Pregnancy</brief_title>
  <acronym>PreBirthCerv</acronym>
  <official_title>Prevention of Preterm Birth by Universal Screening With Ultrasound Measurement of the Consistency Index and Length of the Uterine Cervix in Women With a Single</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Campania &quot;Luigi Vanvitelli&quot;</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Campania &quot;Luigi Vanvitelli&quot;</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Preterm birth (PTB) is the major cause of perinatal morbidity and mortality. Worldwide, about&#xD;
      15 million babies are born too soon every year, causing 1.1 million deaths, as well as short-&#xD;
      and long-term disability in countless survivors. Few prognostic tests are available to&#xD;
      predict PTB. A short transvaginal ultrasound cervical length (TVU CL) has been shown to be a&#xD;
      good predictor of PTB.&#xD;
&#xD;
      Other strategies have been adopted for prevention of PTB. The evidence supports the use of&#xD;
      vaginal progesterone in singleton pregnancies with short cervix.&#xD;
&#xD;
      However, the predictive value of the research has recently been questioned, as the threat&#xD;
      rate from preterms in the low-risk population has not decreased over time. Numerous clinical&#xD;
      studies have been conducted to improve and identify effective prevention strategies in the&#xD;
      threat of preterm birth. Among the parameters studied, in addition to the measurement of the&#xD;
      uterine cervix and its complaints during the three trimesters of pregnancy, an evaluation of&#xD;
      the cervical consistency index (CCI) was also proposed, i.e. an ultrasound evaluation of&#xD;
      cervical softness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Numerous clinical studies have been conducted to improve and identify effective prevention&#xD;
      strategies in the threat of preterm birth. Among the parameters studied, in addition to the&#xD;
      measurement of the uterine cervix and its changes during the three trimesters of pregnancy,&#xD;
      the evaluation of the cervical consistency index (CCI), or an ultrasound evaluation of&#xD;
      cervical softness, was also proposed.&#xD;
&#xD;
      Reduced CCI values correspond to greater compressibility and cervical softness. Studies&#xD;
      conducted to study cervical remodeling on animal models suggest an early increase in cervical&#xD;
      softness that begins immediately after conception followed by shortening and dilation in the&#xD;
      terminal stages of pregnancy so that minimal changes in cervicometry correspond to a&#xD;
      significant increase in cervical softness . Therefore the study of the early stages of&#xD;
      cervical remodeling, such as cervical softness through the ICC, could allow to identify in a&#xD;
      timely manner women with an increased risk of preterm birth.&#xD;
&#xD;
      The purpose of this study is to define and standardize the transvaginal technique to&#xD;
      determine the CCI, its reference range and establish its potential predictive use in the&#xD;
      threat of preterm birth before 32, 34 and 37 weeks.&#xD;
&#xD;
      The purpose of this study is to verify the hypothesis that the introduction of a universal&#xD;
      screening program with TVU CL and CCI measurement, in the three trimesters of pregnancy, may&#xD;
      be associated with a predictive ability to deliver preterm higher than current protocols.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 25, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">October 30, 2021</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>
    <intervention_model_description>This is a prospective, non-pharmacological, non-profit interventional study on women with single pregnancy without a history of previous preterm spontaneous birth. Cervical lenght (CL) and Consistence Cervical Index (CCI) will be assessed by transvaginal ultrasound. CL and CCI measurements will be performed in the first trimester, between 11 and 13 weeks + 6 days, in the second trimester, between 19 and 22 weeks and in the third trimester between 29 and 32 weeks during routine ultrasound examinations for monitoring of pregnancy, in accordance with current national guidelines.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Preterm delivery</measure>
    <time_frame>Less than 37 weeks gestation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gestational age at delivery</measure>
    <time_frame>Time of delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preterm birth rates</measure>
    <time_frame>Less than 24, 28, 34 weeks gestation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Birth weight</measure>
    <time_frame>Time of delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Low birth weight</measure>
    <time_frame>Time of delivery</time_frame>
    <description>Birth weight &lt;2500g</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal death</measure>
    <time_frame>Between birth and 28 days of age</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composite adverse neonatal outcome</measure>
    <time_frame>Between birth and 28 days of age</time_frame>
    <description>Includes necrotizing enterocolitis, intraventricular hemorrhage (grade 3 or higher), respiratory distress syndrome, bronchopulmonary dysplasia (BPD), retinopathy, blood-culture proven sepsis and neonatal death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Admission to neonatal intensive care unit</measure>
    <time_frame>Between birth and 28 days of age</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Pregnancy, High Risk</condition>
  <condition>Preterm Birth</condition>
  <condition>Cervix; Pregnancy</condition>
  <condition>Obstetric Labor, Premature</condition>
  <condition>Obstetric Labor Complications</condition>
  <condition>Pregnancy Complications</condition>
  <arm_group>
    <arm_group_label>CL and CCI screening</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Cervical lenght (CL) and the Consistence Cervix Index (CCI) will be evaluated by transvaginal ultrasound. CL and CCI measurements will be expected in the first trimester, between 11 and 13 weeks + 6 days, in the second trimester, between 19 and 22 weeks and in the third trimester between 29 and 32 weeks during the ultrasound examinations required by the monitoring routine of pregnancy, in accordance with current national guidelines.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No CL and CCI screening</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The investigators collect data of these pregnant women without any additional ultrasound examination</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Transvaginal ultrasound cervical length screening</intervention_name>
    <description>Cervical lenght and Consistence Cervical Index measurements performed, between 11 and 13 weeks + 6 days, in the , between 19 and 22 weeks and i between 29 and 32 weeks during the ultrasound examinations required by the monitoring routine of pregnancy.</description>
    <arm_group_label>CL and CCI screening</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Singleton gestations 18-50 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Multiple gestation Ruptured membranes or fetal structural or chromosomal abnormality at the&#xD;
        time of randomization Labor or cerclage in situ at the time of randomization Women with&#xD;
        altered state of consciousness, seriously ill, with mental handicaps;&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fabiana Savoia, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Campania &quot;Luigi Vanvitelli&quot;</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Maddalena Morlando, MD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Campania &quot;Luigi Vanvitelli&quot;</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pasquale De Franciscis, Prof</last_name>
    <phone>0039 0815665606</phone>
    <email>pasquale.defranciscis@unicampania.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Antonio Schiattarella, MD</last_name>
    <email>aschiattarella@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Campania &quot;Luigi Vanvitelli&quot;</name>
      <address>
        <city>Naples</city>
        <zip>80138</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pasquale De Franciscis, Prof</last_name>
      <phone>0039 0815665606</phone>
      <email>pasquale.defranciscis@unicampania.it</email>
    </contact>
    <contact_backup>
      <last_name>Antonio Schiattarella, MD</last_name>
      <email>aschiattarella@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>June 20, 2020</study_first_submitted>
  <study_first_submitted_qc>June 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>October 17, 2020</last_update_submitted>
  <last_update_submitted_qc>October 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Campania &quot;Luigi Vanvitelli&quot;</investigator_affiliation>
    <investigator_full_name>Prof. Pasquale De Franciscis</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>ultrasound</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
    <mesh_term>Pregnancy Complications</mesh_term>
    <mesh_term>Obstetric Labor Complications</mesh_term>
    <mesh_term>Obstetric Labor, Premature</mesh_term>
  </condition_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/NCT04444206
org study id: 8451
nct id: NCT04444206
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Preterm birth (PTB) is the major cause of perinatal morbidity and mortality. Worldwide, about
      15 million babies are born too soon every year, causing 1.1 million deaths, as well as short-
      and long-term disability in countless survivors. Few prognostic tests are available to
      predict PTB. A short transvaginal ultrasound cervical length (TVU CL) has been shown to be a
      good predictor of PTB.

      Other strategies have been adopted for prevention of PTB. The evidence supports the use of
      vaginal progesterone in singleton pregnancies with short cervix.

      However, the predictive value of the research has recently been questioned, as the threat
      rate from preterms in the low-risk population has not decreased over time. Numerous clinical
      studies have been conducted to improve and identify effective prevention strategies in the
      threat of preterm birth. Among the parameters studied, in addition to the measurement of the
      uterine cervix and its complaints during the three trimesters of pregnancy, an evaluation of
      the cervical consistency index (CCI) was also proposed, i.e. an ultrasound evaluation of
      cervical softness.
Numerous clinical studies have been conducted to improve and identify effective prevention
      strategies in the threat of preterm birth. Among the parameters studied, in addition to the
      measurement of the uterine cervix and its changes during the three trimesters of pregnancy,
      the evaluation of the cervical consistency index (CCI), or an ultrasound evaluation of
      cervical softness, was also proposed.

      Reduced CCI values correspond to greater compressibility and cervical softness. Studies
      conducted to study cervical remodeling on animal models suggest an early increase in cervical
      softness that begins immediately after conception followed by shortening and dilation in the
      terminal stages of pregnancy so that minimal changes in cervicometry correspond to a
      significant increase in cervical softness . Therefore the study of the early stages of
      cervical remodeling, such as cervical softness through the ICC, could allow to identify in a
      timely manner women with an increased risk of preterm birth.

      The purpose of this study is to define and standardize the transvaginal technique to
      determine the CCI, its reference range and establish its potential predictive use in the
      threat of preterm birth before 32, 34 and 37 weeks.

      The purpose of this study is to verify the hypothesis that the introduction of a universal
      screening program with TVU CL and CCI measurement, in the three trimesters of pregnancy, may
      be associated with a predictive ability to deliver preterm higher than current protocols.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a prospective, non-pharmacological, non-profit interventional study on women with single pregnancy without a history of previous preterm spontaneous birth. Cervical lenght (CL) and Consistence Cervical Index (CCI) will be assessed by transvaginal ultrasound. CL and CCI measurements will be performed in the first trimester, between 11 and 13 weeks + 6 days, in the second trimester, between 19 and 22 weeks and in the third trimester between 29 and 32 weeks during routine ultrasound examinations for monitoring of pregnancy, in accordance with current national guidelines.
primary purpose: Diagnostic
masking: Single (Participant)
measure: Preterm delivery
time frame: Less than 37 weeks gestation
measure: Gestational age at delivery
time frame: Time of delivery
measure: Preterm birth rates
time frame: Less than 24, 28, 34 weeks gestation
measure: Birth weight
time frame: Time of delivery
measure: Low birth weight
time frame: Time of delivery
description: Birth weight <2500g
measure: Neonatal death
time frame: Between birth and 28 days of age
measure: Composite adverse neonatal outcome
time frame: Between birth and 28 days of age
description: Includes necrotizing enterocolitis, intraventricular hemorrhage (grade 3 or higher), respiratory distress syndrome, bronchopulmonary dysplasia (BPD), retinopathy, blood-culture proven sepsis and neonatal death
measure: Admission to neonatal intensive care unit
time frame: Between birth and 28 days of age
arm group label: CL and CCI screening
arm group type: Experimental
description: The Cervical lenght (CL) and the Consistence Cervix Index (CCI) will be evaluated by transvaginal ultrasound. CL and CCI measurements will be expected in the first trimester, between 11 and 13 weeks + 6 days, in the second trimester, between 19 and 22 weeks and in the third trimester between 29 and 32 weeks during the ultrasound examinations required by the monitoring routine of pregnancy, in accordance with current national guidelines.
arm group label: No CL and CCI screening
arm group type: No Intervention
description: The investigators collect data of these pregnant women without any additional ultrasound examination
intervention type: Procedure
intervention name: Transvaginal ultrasound cervical length screening
description: Cervical lenght and Consistence Cervical Index measurements performed, between 11 and 13 weeks + 6 days, in the , between 19 and 22 weeks and i between 29 and 32 weeks during the ultrasound examinations required by the monitoring routine of pregnancy.
arm group label: CL and CCI screening
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Fabiana Savoia, MD
role: Principal Investigator
affiliation: University of Campania "Luigi Vanvitelli"
last name: Maddalena Morlando, MD
role: Study Chair
affiliation: University of Campania "Luigi Vanvitelli"
last name: Pasquale De Franciscis, Prof
phone: 0039 0815665606
email: pasquale.defranciscis@unicampania.it
last name: Antonio Schiattarella, MD
email: aschiattarella@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Campania "Luigi Vanvitelli"
investigator full name: Prof. Pasquale De Franciscis
investigator title: Associate Professor
mesh term: Premature Birth
mesh term: Pregnancy Complications
mesh term: Obstetric Labor Complications
mesh term: Obstetric Labor, Premature
sharing ipd: No