<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/NCT03251729</url>
  </required_header>
  <id_info>
    <org_study_id>17D.164</org_study_id>
    <nct_id>NCT03251729</nct_id>
  </id_info>
  <brief_title>Cerclage On LOw Risk Singletons: Cervical Cerclage for Prevention of Spontaneous Preterm Birth in Low Risk Singleton Pregnancies With Short Cervix</brief_title>
  <acronym>COLORS</acronym>
  <official_title>Cervical Cerclage for Preventing Spontaneous Preterm Birth in Singleton Pregnancies Without Prior Spontaneous Preterm Birth and With Short Transvaginal Ultrasound Cervical Length: a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Thomas Jefferson University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Thomas Jefferson University</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>
      The aim of this study is to evaluate the efficacy of cervical cerclage in prevention of&#xD;
      spontaneous preterm birth in singleton pregnancies with a short transvaginal cervical length&#xD;
      (&lt;=25mm) and without prior spontaneous preterm birth&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Singleton pregnancies between 18 0/7 to 23 6/7 weeks without a prior spontaneous preterm&#xD;
      birth found to have a short transvaginal ultrasound cervical length (&lt;=25mm) and meeting all&#xD;
      other eligibility criteria will be randomized to either cervical cerclage or control (no&#xD;
      cerclage). Aside from cerclage placement, management of included women will be the same&#xD;
      including recommendation for daily vaginal progesterone 200mg suppository or 90mg gel from&#xD;
      randomization until 36 6/7 weeks. The primary outcome will be the incidence of spontaneous&#xD;
      preterm birth &lt;35 weeks&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 22, 2017</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">June 2025</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>Randomized trial of cerclage versus no cerclage in singleton pregnancies without prior spontaneous preterm birth and with a short transvaginal ultrasound cervical length</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Preterm birth &lt;35 weeks</measure>
    <time_frame>At delivery</time_frame>
    <description>Incidence of spontaneous preterm birth less than 35 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Preterm birth &lt;37 weeks, &lt;34 weeks, &lt;32 weeks, &lt;28 weeks, &lt;24 weeks</measure>
    <time_frame>At delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean gestational age at delivery</measure>
    <time_frame>At delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Histologically proven clinical chorioamnionitis</measure>
    <time_frame>At delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal outcomes: birth weight</measure>
    <time_frame>At delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal outcomes: low birth weight (&lt;2500g),</measure>
    <time_frame>At delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal outcomes: admission to intensive care nursery</measure>
    <time_frame>At delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal outcomes: length of neonatal hospital admission</measure>
    <time_frame>at least 30 days after delivery, up to 6 months after delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal outcomes: respiratory distress syndrome</measure>
    <time_frame>at least 30 days after delivery, up to 6 months after delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal outcomes: IVH grade 3 or 4</measure>
    <time_frame>at least 30 days after delivery, up to 6 months after delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal outcomes: retinopathy of prematurity</measure>
    <time_frame>at least 30 days after delivery, up to 6 months after delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal outcomes: bronchopulmonary dysplasia</measure>
    <time_frame>at least 30 days after delivery, up to 6 months after delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal outcomes: neonatal mortality</measure>
    <time_frame>28 days after delivery</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">206</enrollment>
  <condition>Premature Birth</condition>
  <arm_group>
    <arm_group_label>Cerclage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cervical cerclage placement along with vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cervical cerclage</intervention_name>
    <description>Transvaginal cervical cerclage placed between 18 0/7 - 23 6/7 weeks</description>
    <arm_group_label>Cerclage</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vaginal progesterone</intervention_name>
    <description>Vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks</description>
    <arm_group_label>Cerclage</arm_group_label>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 year old or older&#xD;
&#xD;
          -  Singleton pregnancy&#xD;
&#xD;
          -  No prior SPTB or second trimester losses between 160 and 366 weeks&#xD;
&#xD;
          -  TVU CL ≤25mm between 180 and 236 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multiple pregnancy&#xD;
&#xD;
          -  Prior SPTB or second trimester losses between 160 and 366 weeks&#xD;
&#xD;
          -  Cerclage in situ&#xD;
&#xD;
          -  Painful regular uterine contraction and/or preterm labor&#xD;
&#xD;
          -  Rupture membranes&#xD;
&#xD;
          -  Major fetal anomaly or aneuploidy&#xD;
&#xD;
          -  Active vaginal bleeding&#xD;
&#xD;
          -  Placenta previa and/or accreta&#xD;
&#xD;
          -  Cervical dilation &gt;1.0 cm and/or visible membranes by pelvic exam&#xD;
&#xD;
          -  Suspicion of chorioamnionitis&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Patients must be pregnant to be enrolled. Self-represented gender identity is NOT a basis of eligibility</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Vincenzo Berghella, MD</last_name>
    <phone>215-955-9200</phone>
    <email>vincenzo.berghella@jefferson.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rupsa C Boelig, MD</last_name>
    <phone>215-955-9196</phone>
    <email>rupsa.boelig@jefferson.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Thomas Jefferson University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rupsa C Boelig, MD</last_name>
      <email>rupsa.boelig@jefferson.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Naples Federico II</name>
      <address>
        <city>Naples</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gabriele Saccone, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Cattolica del S. Cuore</name>
      <address>
        <city>Rome</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicoletta Di Simone</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Berghella V, Ciardulli A, Rust OA, To M, Otsuki K, Althuisius S, Nicolaides KH, Roman A, Saccone G. Cerclage for sonographic short cervix in singleton gestations without prior spontaneous preterm birth: systematic review and meta-analysis of randomized controlled trials using individual patient-level data. Ultrasound Obstet Gynecol. 2017 Nov;50(5):569-577. doi: 10.1002/uog.17457. Epub 2017 Oct 5.</citation>
    <PMID>28295722</PMID>
  </reference>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>June 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>February 4, 2022</last_update_submitted>
  <last_update_submitted_qc>February 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cerclage, preterm birth, short cervix</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Progesterone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03251729
org study id: 17D.164
nct id: NCT03251729
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate the efficacy of cervical cerclage in prevention of
      spontaneous preterm birth in singleton pregnancies with a short transvaginal cervical length
      (<=25mm) and without prior spontaneous preterm birth
Singleton pregnancies between 18 0/7 to 23 6/7 weeks without a prior spontaneous preterm
      birth found to have a short transvaginal ultrasound cervical length (<=25mm) and meeting all
      other eligibility criteria will be randomized to either cervical cerclage or control (no
      cerclage). Aside from cerclage placement, management of included women will be the same
      including recommendation for daily vaginal progesterone 200mg suppository or 90mg gel from
      randomization until 36 6/7 weeks. The primary outcome will be the incidence of spontaneous
      preterm birth <35 weeks
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized trial of cerclage versus no cerclage in singleton pregnancies without prior spontaneous preterm birth and with a short transvaginal ultrasound cervical length
primary purpose: Treatment
masking: None (Open Label)
measure: Preterm birth <35 weeks
time frame: At delivery
description: Incidence of spontaneous preterm birth less than 35 weeks
measure: Preterm birth <37 weeks, <34 weeks, <32 weeks, <28 weeks, <24 weeks
time frame: At delivery
measure: Mean gestational age at delivery
time frame: At delivery
measure: Histologically proven clinical chorioamnionitis
time frame: At delivery
measure: Neonatal outcomes: birth weight
time frame: At delivery
measure: Neonatal outcomes: low birth weight (<2500g),
time frame: At delivery
measure: Neonatal outcomes: admission to intensive care nursery
time frame: At delivery
measure: Neonatal outcomes: length of neonatal hospital admission
time frame: at least 30 days after delivery, up to 6 months after delivery
measure: Neonatal outcomes: respiratory distress syndrome
time frame: at least 30 days after delivery, up to 6 months after delivery
measure: Neonatal outcomes: IVH grade 3 or 4
time frame: at least 30 days after delivery, up to 6 months after delivery
measure: Neonatal outcomes: retinopathy of prematurity
time frame: at least 30 days after delivery, up to 6 months after delivery
measure: Neonatal outcomes: bronchopulmonary dysplasia
time frame: at least 30 days after delivery, up to 6 months after delivery
measure: Neonatal outcomes: neonatal mortality
time frame: 28 days after delivery
arm group label: Cerclage
arm group type: Experimental
description: Cervical cerclage placement along with vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks.
arm group label: Control
arm group type: Other
description: Vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks.
intervention type: Procedure
intervention name: Cervical cerclage
description: Transvaginal cervical cerclage placed between 18 0/7 - 23 6/7 weeks
arm group label: Cerclage
intervention type: Drug
intervention name: Vaginal progesterone
description: Vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks
arm group label: Cerclage
arm group label: Control
criteria: 
gender: Female
gender based: Yes
gender description: Patients must be pregnant to be enrolled. Self-represented gender identity is NOT a basis of eligibility
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Vincenzo Berghella, MD
phone: 215-955-9200
email: vincenzo.berghella@jefferson.edu
last name: Rupsa C Boelig, MD
phone: 215-955-9196
email: rupsa.boelig@jefferson.edu
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Italy
country: United States
citation: Berghella V, Ciardulli A, Rust OA, To M, Otsuki K, Althuisius S, Nicolaides KH, Roman A, Saccone G. Cerclage for sonographic short cervix in singleton gestations without prior spontaneous preterm birth: systematic review and meta-analysis of randomized controlled trials using individual patient-level data. Ultrasound Obstet Gynecol. 2017 Nov;50(5):569-577. doi: 10.1002/uog.17457. Epub 2017 Oct 5.
PMID: 28295722
responsible party type: Sponsor
mesh term: Premature Birth
mesh term: Progesterone
sharing ipd: Undecided