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/NCT06036446</url>
    </required_header>
    <id_info>
      <org_study_id>iRISID-2023-2321</org_study_id>
      <nct_id>NCT06036446</nct_id>
    </id_info>
    <brief_title>LATe Cerclage in High-risk Pregnancies</brief_title>
    <acronym>LATCH</acronym>
    <official_title>Cervical Cerclage for Short Cervix at 24-26 Weeks of Gestation: a Randomized Controlled 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 goal of this clinical trial is to determine whether cervical cerclage reduces the risk of&#xD;
        preterm birth in patients with a short transvaginal cervical length (≤25mm) between 24 0/7-26&#xD;
        6/7 weeks.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Singleton high-risk pregnancies &lt; 24 weeks of gestation will be screened for enrollment and&#xD;
        randomized, if a short transvaginal cervical length (≤25mm) is detected between 24 0/7 - 26&#xD;
        6/7 weeks, to either cervical cerclage or control (no cerclage). Aside from cerclage&#xD;
        placement, management of included women will be the same including recommendation for&#xD;
        continuing or initiating daily vaginal progesterone 200mg from randomization until 36 6/7&#xD;
        weeks. The primary outcome will be the incidence of preterm birth &lt;37 weeks.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">February 2027</completion_date>
    <primary_completion_date type="Anticipated">October 2026</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 high-risk pregnancies with a short transvaginal ultrasound cervical length at 24-26 weeks of gestation.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of preterm birth &lt;37 weeks</measure>
      <time_frame>At delivery</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Incidence of preterm birth &lt;34 weeks, &lt;32 weeks, and &lt;28 weeks</measure>
      <time_frame>At delivery</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gestational age at delivery</measure>
      <time_frame>At delivery</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time interval from randomization to delivery</measure>
      <time_frame>At delivery</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of preterm prelabor rupture of membranes (PPROM)</measure>
      <time_frame>At occurrence up to 36 weeks and 6 days of gestation</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of intraamniotic infection</measure>
      <time_frame>At the time of delivery at any gestational age</time_frame>
      <description>Defined by either presence of clinical criteria (i.e. includes maternal fever [temperature &gt; 100.4 on two occasions at least 30 minutes apart] and one or more of the following: maternal leukocytosis [WBC &gt; 15,000], purulent cervical drainage, or fetal tachycardia), laboratory testing (positive amniotic fluid test result [gram stain, glucose level [&lt;15], or culture results consistent with infection]), or placental pathology demonstrating histologic evidence of placental infection or inflammation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neonatal outcomes: incidence of low birthweight (&lt;2500g)</measure>
      <time_frame>At delivery</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neonatal outcomes: incidence of very low birthweight (&lt;1500g)</measure>
      <time_frame>At delivery</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neonatal outcomes: incidence of admission to neonatal intensive care unit</measure>
      <time_frame>At delivery</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neonatal outcomes: composite outcome of incidence of either respiratory distress syndrome, bronchopulmonary dysplasia, grade 3 or 4 intraventricular hemorrhage, necrotizing enterocolitis, culture confirmed sepsis, stillbirth, and neonatal mortality</measure>
      <time_frame>At least 30 days after delivery, up to 6 months after delivery for outcomes except neonatal mortality</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">329</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 with removal during the 36th week of gestation or earlier if clinically indicated.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Continuing or initiation of vaginal progesterone 200mg daily until 36 weeks of gestation.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Cervical cerclage</intervention_name>
      <description>Transvaginal cervical cerclage placed between 24 0/7 - 26 6/7 weeks of gestation.</description>
      <arm_group_label>Cerclage</arm_group_label>
      <other_name>Cerclage</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Vaginal Suppository Progesterone</intervention_name>
      <description>Continuing or initiation of vaginal progesterone 200mg daily until 36 weeks of gestation.</description>
      <arm_group_label>Cerclage</arm_group_label>
      <arm_group_label>Control</arm_group_label>
      <other_name>Vaginal progesterone</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18-50 years old, pregnant, assigned female at birth&#xD;
  &#xD;
            -  Singleton pregnancy&#xD;
  &#xD;
            -  TVU CL ≤25mm between 24 0/7 - 26 6/7 weeks of gestation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Initial multifetal gestation with subsequent multifetal pregnancy reduction, or&#xD;
               selective fetal termination performed &gt;14 weeks, or cotwin pregnancy loss diagnosed&#xD;
               &gt;14 weeks&#xD;
  &#xD;
            -  Cerclage in situ&#xD;
  &#xD;
            -  Preterm labor, defined as painful regular uterine contractions and change in cervical&#xD;
               dilation&#xD;
  &#xD;
            -  Preterm prelabor rupture of membranes (PPROM)&#xD;
  &#xD;
            -  Active vaginal bleeding&#xD;
  &#xD;
            -  Suspected intraamniotic infection&#xD;
  &#xD;
            -  Major fetal structural abnormality or chromosomal disorder&#xD;
  &#xD;
            -  Placenta previa or accreta&#xD;
  &#xD;
            -  Other contraindication to cerclage placement&#xD;
  &#xD;
            -  Participation in another clinical trial related to PTB prevention, cerclage, or&#xD;
               progesterone&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Moti Gulersen, MD, MSc</last_name>
      <role>Principal Investigator</role>
      <affiliation>Thomas Jefferson University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Moti Gulersen, MD, MSc</last_name>
      <phone>215-955-5000</phone>
      <email>moti.gulersen@jefferson.edu</email>
    </overall_contact>
    <reference>
      <citation>Gulersen M, Lenchner E, Nicolaides KH, Otsuki K, Rust OA, Althuisius S, Bornstein E, Berghella V. Cervical cerclage for short cervix at 24 to 26 weeks of gestation: systematic review and meta-analysis of randomized controlled trials using individual patient-level data. Am J Obstet Gynecol MFM. 2023 Jun;5(6):100930. doi: 10.1016/j.ajogmf.2023.100930. Epub 2023 Mar 15.</citation>
      <PMID>36924844</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Cervical length</keyword>
    <keyword>Short cervix</keyword>
    <keyword>Shortened cervix</keyword>
    <keyword>Prematurity</keyword>
    <keyword>Preterm birth</keyword>
    <keyword>Viability</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>
    <!-- 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/NCT06036446
  org study id: iRISID-2023-2321
  nct id: NCT06036446
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to determine whether cervical cerclage reduces the risk of
        preterm birth in patients with a short transvaginal cervical length (≤25mm) between 24 0/7-26
        6/7 weeks.
  Singleton high-risk pregnancies < 24 weeks of gestation will be screened for enrollment and
        randomized, if a short transvaginal cervical length (≤25mm) is detected between 24 0/7 - 26
        6/7 weeks, to either cervical cerclage or control (no cerclage). Aside from cerclage
        placement, management of included women will be the same including recommendation for
        continuing or initiating daily vaginal progesterone 200mg from randomization until 36 6/7
        weeks. The primary outcome will be the incidence of preterm birth <37 weeks.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized trial of cerclage versus no cerclage in singleton high-risk pregnancies with a short transvaginal ultrasound cervical length at 24-26 weeks of gestation.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Incidence of preterm birth <37 weeks
  time frame: At delivery
  measure: Incidence of preterm birth <34 weeks, <32 weeks, and <28 weeks
  time frame: At delivery
  measure: Gestational age at delivery
  time frame: At delivery
  measure: Time interval from randomization to delivery
  time frame: At delivery
  measure: Incidence of preterm prelabor rupture of membranes (PPROM)
  time frame: At occurrence up to 36 weeks and 6 days of gestation
  measure: Incidence of intraamniotic infection
  time frame: At the time of delivery at any gestational age
  description: Defined by either presence of clinical criteria (i.e. includes maternal fever [temperature > 100.4 on two occasions at least 30 minutes apart] and one or more of the following: maternal leukocytosis [WBC > 15,000], purulent cervical drainage, or fetal tachycardia), laboratory testing (positive amniotic fluid test result [gram stain, glucose level [<15], or culture results consistent with infection]), or placental pathology demonstrating histologic evidence of placental infection or inflammation.
  measure: Neonatal outcomes: incidence of low birthweight (<2500g)
  time frame: At delivery
  measure: Neonatal outcomes: incidence of very low birthweight (<1500g)
  time frame: At delivery
  measure: Neonatal outcomes: incidence of admission to neonatal intensive care unit
  time frame: At delivery
  measure: Neonatal outcomes: composite outcome of incidence of either respiratory distress syndrome, bronchopulmonary dysplasia, grade 3 or 4 intraventricular hemorrhage, necrotizing enterocolitis, culture confirmed sepsis, stillbirth, and neonatal mortality
  time frame: At least 30 days after delivery, up to 6 months after delivery for outcomes except neonatal mortality
  arm group label: Cerclage
  arm group type: Experimental
  description: Cervical cerclage placement with removal during the 36th week of gestation or earlier if clinically indicated.
  arm group label: Control
  arm group type: Other
  description: Continuing or initiation of vaginal progesterone 200mg daily until 36 weeks of gestation.
  intervention type: Procedure
  intervention name: Cervical cerclage
  description: Transvaginal cervical cerclage placed between 24 0/7 - 26 6/7 weeks of gestation.
  arm group label: Cerclage
  other name: Cerclage
  intervention type: Drug
  intervention name: Vaginal Suppository Progesterone
  description: Continuing or initiation of vaginal progesterone 200mg daily until 36 weeks of gestation.
  arm group label: Cerclage
  arm group label: Control
  other name: Vaginal progesterone
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Moti Gulersen, MD, MSc
  role: Principal Investigator
  affiliation: Thomas Jefferson University
  last name: Moti Gulersen, MD, MSc
  phone: 215-955-5000
  email: moti.gulersen@jefferson.edu
  citation: Gulersen M, Lenchner E, Nicolaides KH, Otsuki K, Rust OA, Althuisius S, Bornstein E, Berghella V. Cervical cerclage for short cervix at 24 to 26 weeks of gestation: systematic review and meta-analysis of randomized controlled trials using individual patient-level data. Am J Obstet Gynecol MFM. 2023 Jun;5(6):100930. doi: 10.1016/j.ajogmf.2023.100930. Epub 2023 Mar 15.
  PMID: 36924844
  responsible party type: Sponsor
  mesh term: Premature Birth
  mesh term: Progesterone