<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/NCT03022591</url>
  </required_header>
  <id_info>
    <org_study_id>27027</org_study_id>
    <nct_id>NCT03022591</nct_id>
  </id_info>
  <brief_title>Short Cervix - Twins</brief_title>
  <official_title>Management of Twins With Short Cervix at a Single Institution: A Retrospective Review</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Louis University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Louis University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a retrospective chart review. The purpose of this study will be to look at the&#xD;
      outcomes of twin pregnancies diagnosed with short cervix along with the intervention&#xD;
      (treatment) that these patients received.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In 2010, the incidence of preterm birth in twin gestations was 23% before 34 weeks and 58%&#xD;
      before 37 weeks, while the overall incidence of PTB in all pregnancies was only 3.41% and&#xD;
      11.5%, respectively. Twin gestations are also at increased risk of being low birth weight&#xD;
      infants.&#xD;
&#xD;
      Goldenberg et al demonstrated in 1996 that a cervical length less than 25 mm at 24 weeks&#xD;
      gestation in twin pregnancies was the best predictor of preterm birth at &lt;32 weeks, &lt;35&#xD;
      weeks, and &lt; 37 weeks. In 1999, Souka et al reported that in twin pregnancies with a cervical&#xD;
      length less than 15 mm at 23 weeks gestation, the preterm birth rate &lt;32 weeks was&#xD;
      approximately 66%.&#xD;
&#xD;
      A Cochrane Review from 2014 concluded that placing a cerclage is not associated with a&#xD;
      significant difference regarding perinatal deaths or neonatal morbidity, but this analysis&#xD;
      was for all forms of cerclage in multiple gestations (physical examination-indicated,&#xD;
      history-indicated, and ultrasound-indicated). It did also state &quot;ultrasound-indicated&#xD;
      cerclage appears to be associated with an increased risk for the composite adverse neonatal&#xD;
      outcome, including respiratory distress syndrome, low and very low birthweight, given there&#xD;
      is no evidence of a consistent subgroup effect, the observed results can most likely be&#xD;
      attributed to chance.&quot;&#xD;
&#xD;
      In a 2015 retrospective cohort study of twin pregnancies with asymptomatic short cervix,&#xD;
      Amanda Roman et al demonstrate similar results to those of the Cochrane Review for patients&#xD;
      with CL &lt;25 mm. However, they did show a trend towards prolonged pregnancy, decreased&#xD;
      spontaneous PTB &lt;34 weeks, and fewer NICU admissions for a subset of patients with CL &lt; 15 mm&#xD;
      that received a cerclage compared to control.&#xD;
&#xD;
      In February 2016, Goya et al investigated the role of the pessary for women with twin&#xD;
      gestations and short cervix diagnosed via ultrasound. A significant reduction in the rate of&#xD;
      preterm birth prior to 34 weeks was found in the pessary group (16.2% vs 39.4%), with no&#xD;
      significant differences in neonatal morbidity or mortality.&#xD;
&#xD;
      Chart review will collect information documented on the data collection sheet, including&#xD;
      medical and OB history, current pregnancy course, treatment for short cervix and information&#xD;
      on hospitalization including labor and delivery, postpartum course and neonatal birth&#xD;
      information.&#xD;
&#xD;
      The investigators will analyses and compare this group of women using short cervix diagnosis,&#xD;
      management decisions and outcomes during the antepartum period, labor, delivery and post&#xD;
      partum course for possible signs and symptoms of those at risk for Pre Term Birth and&#xD;
      outcomes of their infants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">February 2018</completion_date>
  <primary_completion_date type="Actual">January 2018</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Short cervix</measure>
    <time_frame>1 year</time_frame>
    <description>management decisions and outcomes of twin pregnancies diagnosed with short cervix.</description>
  </primary_outcome>
  <enrollment type="Actual">6</enrollment>
  <condition>Short Cervix</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Management</intervention_name>
    <description>management of twin pregnancies with a short cervix diagnosed between 16 0/7 WGA to 27 6/7 WGA.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        14-55yrs of age Female all ethnic backgrounds&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Charts of all women who had twins and a short cervix will be reviewed,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  singleton&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laure Vricella, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Louis University</affiliation>
  </overall_official>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>February 8, 2018</last_update_submitted>
  <last_update_submitted_qc>February 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Louis University</investigator_affiliation>
    <investigator_full_name>Laura Vricella, MD</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <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/NCT03022591
org study id: 27027
nct id: NCT03022591
lead sponsor: 
has dmc: No
This is a retrospective chart review. The purpose of this study will be to look at the
      outcomes of twin pregnancies diagnosed with short cervix along with the intervention
      (treatment) that these patients received.
In 2010, the incidence of preterm birth in twin gestations was 23% before 34 weeks and 58%
      before 37 weeks, while the overall incidence of PTB in all pregnancies was only 3.41% and
      11.5%, respectively. Twin gestations are also at increased risk of being low birth weight
      infants.

      Goldenberg et al demonstrated in 1996 that a cervical length less than 25 mm at 24 weeks
      gestation in twin pregnancies was the best predictor of preterm birth at <32 weeks, <35
      weeks, and < 37 weeks. In 1999, Souka et al reported that in twin pregnancies with a cervical
      length less than 15 mm at 23 weeks gestation, the preterm birth rate <32 weeks was
      approximately 66%.

      A Cochrane Review from 2014 concluded that placing a cerclage is not associated with a
      significant difference regarding perinatal deaths or neonatal morbidity, but this analysis
      was for all forms of cerclage in multiple gestations (physical examination-indicated,
      history-indicated, and ultrasound-indicated). It did also state "ultrasound-indicated
      cerclage appears to be associated with an increased risk for the composite adverse neonatal
      outcome, including respiratory distress syndrome, low and very low birthweight, given there
      is no evidence of a consistent subgroup effect, the observed results can most likely be
      attributed to chance."

      In a 2015 retrospective cohort study of twin pregnancies with asymptomatic short cervix,
      Amanda Roman et al demonstrate similar results to those of the Cochrane Review for patients
      with CL <25 mm. However, they did show a trend towards prolonged pregnancy, decreased
      spontaneous PTB <34 weeks, and fewer NICU admissions for a subset of patients with CL < 15 mm
      that received a cerclage compared to control.

      In February 2016, Goya et al investigated the role of the pessary for women with twin
      gestations and short cervix diagnosed via ultrasound. A significant reduction in the rate of
      preterm birth prior to 34 weeks was found in the pessary group (16.2% vs 39.4%), with no
      significant differences in neonatal morbidity or mortality.

      Chart review will collect information documented on the data collection sheet, including
      medical and OB history, current pregnancy course, treatment for short cervix and information
      on hospitalization including labor and delivery, postpartum course and neonatal birth
      information.

      The investigators will analyses and compare this group of women using short cervix diagnosis,
      management decisions and outcomes during the antepartum period, labor, delivery and post
      partum course for possible signs and symptoms of those at risk for Pre Term Birth and
      outcomes of their infants.
observational model: Cohort
time perspective: Retrospective
measure: Short cervix
time frame: 1 year
description: management decisions and outcomes of twin pregnancies diagnosed with short cervix.
intervention type: Other
intervention name: Management
description: management of twin pregnancies with a short cervix diagnosed between 16 0/7 WGA to 27 6/7 WGA.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 14 Years
maximum age: 55 Years
healthy volunteers: No
last name: Laure Vricella, MD
role: Principal Investigator
affiliation: St. Louis University
responsible party type: Principal Investigator
investigator affiliation: St. Louis University
investigator full name: Laura Vricella, MD
investigator title: Principal investigator
sharing ipd: No