<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/NCT03781466</url>
  </required_header>
  <id_info>
    <org_study_id>aswu/190/18</org_study_id>
    <nct_id>NCT03781466</nct_id>
  </id_info>
  <brief_title>Effect of Cervical Cerclage With Vaginal Progesterone in Asymptomatic Twin Pregnancies With a Sonographic Short Cervix</brief_title>
  <official_title>Effect of Cervical Cerclage With or Without Vaginal Progesterone Versus Vaginal Progesterone Alone for Prevention of Preterm Labor in Asymptomatic Twin Pregnancies With a Sonographic Short Cervix: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aswan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aswan University Hospital</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 objective of the present study is to evaluate the effectiveness of vaginal progesterone&#xD;
      and cervical cerclage each alone and in combination in improving gestational age in twin&#xD;
      pregnancy and its subsequent impact on perinatal outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is a lack of effective, evidence-based interventions for the prevention of preterm&#xD;
      birth in twin pregnancies. There is limited evidence for the use of vaginal progesterone and&#xD;
      cervical cerclage, and the cervical pessary is currently only used within a research setting.&#xD;
      There are no reported trials comparing the effectiveness of each of these interventions&#xD;
      against each other, whether in isolation or in combination. Research is needed to further&#xD;
      evaluate the benefit of the cervical pessary and the use of cervical cerclage in twins of&#xD;
      women with a short cervix. A recent article by Stock et al.concludes by advising clinicians&#xD;
      to share with women the uncertainty of methods to prevent PTB in multiple pregnancies, and&#xD;
      offer the opportunity to participate in clinical trials. So the objective of the present&#xD;
      study is to evaluate the effectiveness of vaginal progesterone and cervical cerclage each&#xD;
      alone and in combination in improving gestational age in twin pregnancy and its subsequent&#xD;
      impact on perinatal outcome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">March 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</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>A randomized clinical trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>A randomized clinical trial open label</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Preterm labor before 34 weeks</measure>
    <time_frame>Up to 34 weeks gestational age</time_frame>
    <description>Number of patients with preterm birth before 34 weeks gestations</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neonatal respiratory distress syndrome</measure>
    <time_frame>At birth</time_frame>
    <description>number of neonatal respiratory distress syndrome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Early neonatal death</measure>
    <time_frame>within one month postpartum</time_frame>
    <description>number babies died in the neonatal period</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Twin; Pregnancy, Affecting Fetus or Newborn</condition>
  <arm_group>
    <arm_group_label>Cervical cerclage</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cervical cerclage in twin pregnancy with transvaginal cervical length ≤25mm</description>
  </arm_group>
  <arm_group>
    <arm_group_label>vaginal progesterone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Daily vaginal progesterone 400mg from diagnosis of the short cervix to 36 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cervical cerclage plus vaginal progesterone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cervical cerclage in twin pregnancy with transvaginal cervical length ≤25mm plus Daily vaginal progesterone 400mg from diagnosis of the short cervix to 36 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cervical cerclage</intervention_name>
    <description>Cervical cerclage indicated by short cervix ≤25mm</description>
    <arm_group_label>Cervical cerclage</arm_group_label>
    <arm_group_label>Cervical cerclage plus vaginal progesterone</arm_group_label>
    <other_name>Active Comparator</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>vaginal progesterone</intervention_name>
    <description>Daily vaginal progesterone 400mg from diagnosis of short cervix to 36 weeks</description>
    <arm_group_label>Cervical cerclage plus vaginal progesterone</arm_group_label>
    <arm_group_label>vaginal progesterone</arm_group_label>
    <other_name>Active Comparator</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women pregnant in dichorionic twins.&#xD;
&#xD;
          -  Transvaginal sonographic cervical length is &lt;25 mm at 16-20 weeks gestational age.&#xD;
&#xD;
          -  No symptoms, signs or other risk factors for preterm labor&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years or &gt; 45 years.&#xD;
&#xD;
          -  Known allergy or contraindication (relative or absolute) to progesterone therapy.&#xD;
&#xD;
          -  Monochorionic twins.&#xD;
&#xD;
          -  Known major fetal structural or chromosomal abnormality.&#xD;
&#xD;
          -  Intrauterine death of one fetus or death of both fetuses.&#xD;
&#xD;
          -  Fetal reduction in the current pregnancy.&#xD;
&#xD;
          -  Medical conditions that may lead to preterm delivery.&#xD;
&#xD;
          -  Rupture of membranes.&#xD;
&#xD;
          -  Vaginal bleeding&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Women pregnant in dichorionic twins</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>hany f sallam, md</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aswan University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>hany f sallam, md</last_name>
    <phone>01022336052</phone>
    <phone_ext>002</phone_ext>
    <email>hany.farouk@aswu.edu.eg</email>
  </overall_contact>
  <location>
    <facility>
      <name>Aswan University</name>
      <address>
        <city>Aswan</city>
        <zip>81528</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>hany f sallam, md</last_name>
      <phone>01092440504</phone>
      <phone_ext>002</phone_ext>
      <email>nahla.elsayed@aswu.ed.eg</email>
    </contact>
    <contact_backup>
      <last_name>Nahla w Shady, md</last_name>
      <phone>1019240504</phone>
      <phone_ext>002</phone_ext>
      <email>nahla.elsayed@aswu.edu.eg</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>February 14, 2019</last_update_submitted>
  <last_update_submitted_qc>February 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aswan University Hospital</investigator_affiliation>
    <investigator_full_name>hany farouk</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Preterm birth</keyword>
  <keyword>Twin gestation</keyword>
  <keyword>Vaginal progesterone</keyword>
  <keyword>cervical cerclage</keyword>
  <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/NCT03781466
org study id: aswu/190/18
nct id: NCT03781466
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The objective of the present study is to evaluate the effectiveness of vaginal progesterone
      and cervical cerclage each alone and in combination in improving gestational age in twin
      pregnancy and its subsequent impact on perinatal outcome.
There is a lack of effective, evidence-based interventions for the prevention of preterm
      birth in twin pregnancies. There is limited evidence for the use of vaginal progesterone and
      cervical cerclage, and the cervical pessary is currently only used within a research setting.
      There are no reported trials comparing the effectiveness of each of these interventions
      against each other, whether in isolation or in combination. Research is needed to further
      evaluate the benefit of the cervical pessary and the use of cervical cerclage in twins of
      women with a short cervix. A recent article by Stock et al.concludes by advising clinicians
      to share with women the uncertainty of methods to prevent PTB in multiple pregnancies, and
      offer the opportunity to participate in clinical trials. So the objective of the present
      study is to evaluate the effectiveness of vaginal progesterone and cervical cerclage each
      alone and in combination in improving gestational age in twin pregnancy and its subsequent
      impact on perinatal outcome.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A randomized clinical trial
primary purpose: Prevention
masking: None (Open Label)
masking description: A randomized clinical trial open label
measure: Preterm labor before 34 weeks
time frame: Up to 34 weeks gestational age
description: Number of patients with preterm birth before 34 weeks gestations
measure: Neonatal respiratory distress syndrome
time frame: At birth
description: number of neonatal respiratory distress syndrome
measure: Early neonatal death
time frame: within one month postpartum
description: number babies died in the neonatal period
arm group label: Cervical cerclage
arm group type: Active Comparator
description: Cervical cerclage in twin pregnancy with transvaginal cervical length ≤25mm
arm group label: vaginal progesterone
arm group type: Active Comparator
description: Daily vaginal progesterone 400mg from diagnosis of the short cervix to 36 weeks
arm group label: Cervical cerclage plus vaginal progesterone
arm group type: Active Comparator
description: Cervical cerclage in twin pregnancy with transvaginal cervical length ≤25mm plus Daily vaginal progesterone 400mg from diagnosis of the short cervix to 36 weeks
intervention type: Procedure
intervention name: Cervical cerclage
description: Cervical cerclage indicated by short cervix ≤25mm
arm group label: Cervical cerclage
arm group label: Cervical cerclage plus vaginal progesterone
other name: Active Comparator
intervention type: Drug
intervention name: vaginal progesterone
description: Daily vaginal progesterone 400mg from diagnosis of short cervix to 36 weeks
arm group label: Cervical cerclage plus vaginal progesterone
arm group label: vaginal progesterone
other name: Active Comparator
criteria: 
gender: Female
gender based: Yes
gender description: Women pregnant in dichorionic twins
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: hany f sallam, md
role: Principal Investigator
affiliation: Aswan University Hospital
last name: hany f sallam, md
phone: 01022336052
phone ext: 002
email: hany.farouk@aswu.edu.eg
facility: 
status: Recruiting
contact: 
contact backup: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Aswan University Hospital
investigator full name: hany farouk
investigator title: Principal Investigator
mesh term: Progesterone
sharing ipd: Undecided