<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/NCT03781674</url>
  </required_header>
  <id_info>
    <org_study_id>aswu/194/18</org_study_id>
    <nct_id>NCT03781674</nct_id>
  </id_info>
  <brief_title>Role of 200 mg Versus 400mg Vaginal Progesterone in Prevention of Preterm Labor in Twin Gestation</brief_title>
  <official_title>Evaluation of the Role of 200 mg Versus 400mg Vaginal Progesterone in Prevention of Preterm Labor in Twin Gestation With Short Cervix: a Double-Blind Randomized Controlled 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>No</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 two doses of vaginal&#xD;
      progesterone(200mg versus400mg) and placebo in improving gestational age in twin pregnancy&#xD;
      and its subsequent impact on perinatal outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The use of progesterone in the prevention of preterm birth(PTB) in both singleton and&#xD;
      multiple pregnancies has been extensively investigated. Arguably, the use of progesterone is&#xD;
      biologically plausible given that uterine quiescence is maintained throughout pregnancy by&#xD;
      progesterone and progesterone receptor-mediated inhibition of inflammation, which causes&#xD;
      suppression of the contractile genes. There is no benefit of universal vaginal progesterone&#xD;
      to reduce PTB rates in multiple pregnancies. One meta-analysis showed a benefit in adverse&#xD;
      perinatal outcome in a subgroup of women with a short cervix ≤25 mm, suggesting it may be&#xD;
      useful in this group, but the numbers in the study were small and further research is needed.&#xD;
      There appears to be no long-term harm caused to infants exposed to progesterone in utero. So&#xD;
      the aim of the present study is to evaluate the effectiveness of two doses of vaginal&#xD;
      progesterone(200mg versus400mg) and placebo in improving gestational age in twin pregnancy&#xD;
      and its subsequent 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, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 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>a double-blind randomized controlled trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>a double-blind randomized controlled trial</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Preterm labor before 34 weeks gestations</measure>
    <time_frame>Up to 34 weeks gestational age</time_frame>
    <description>Number of patients delivered before 34 weeks gestations</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neonatal respiratory distress syndrome</measure>
    <time_frame>At birth</time_frame>
    <description>Number of neonates develop respiratory distress syndrome</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Early neonatal death</measure>
    <time_frame>One month after birth</time_frame>
    <description>number of neonates died within one month from birth</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Twin; Pregnancy, Affecting Fetus or Newborn</condition>
  <arm_group>
    <arm_group_label>progesterone 400mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Women received vaginal progesterone suppositories in a dose of 400 mg(4 tablets) daily beginning at 18-22 weeks gestational age</description>
  </arm_group>
  <arm_group>
    <arm_group_label>progesterone 200mg plus placebo to progesterone 200 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Women received vaginal progesterone suppositories in a dose of 200 mg(2 tablets) daily beginning at 18-22 weeks gestational age plus 2tablets placebo to vaginal progesterone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo to progesterone 400 mg</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Women received 4 tablets placebo to vaginal progesterone suppositories</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>progesterone 400mg</intervention_name>
    <description>Women received vaginal progesterone suppositories in a dose of 400 mg daily beginning at 18-22 weeks gestational age</description>
    <arm_group_label>progesterone 400mg</arm_group_label>
    <other_name>Active Comparator</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>progesterone 200mg</intervention_name>
    <description>Women received vaginal progesterone suppositories in a dose of 200 mg daily beginning at 18-22 weeks gestational age</description>
    <arm_group_label>progesterone 200mg plus placebo to progesterone 200 mg</arm_group_label>
    <other_name>Active Comparator</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo to progesterone 200mg</intervention_name>
    <description>Women received placebo to vaginal progesterone 200 mg suppositories in a dose of (2 tablets) daily beginning at 18-22 weeks gestational age</description>
    <arm_group_label>placebo to progesterone 400 mg</arm_group_label>
    <arm_group_label>progesterone 200mg plus placebo to progesterone 200 mg</arm_group_label>
    <other_name>Placebo comparator</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo to progesterone 400mg</intervention_name>
    <description>Women received placebo to vaginal progesterone 400 mg suppositories in a dose of (4 tablets) daily beginning at 18-22 weeks gestational age</description>
    <arm_group_label>placebo to progesterone 400 mg</arm_group_label>
    <other_name>placebo 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 18-22 weeks gestational age.&#xD;
&#xD;
          -  No symptoms, signs or other risk factors for preterm labor.&#xD;
&#xD;
        Exclusion Criteria:&#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;
          -  Cervical cerclage 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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obstetric Labor, Premature</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/NCT03781674
org study id: aswu/194/18
nct id: NCT03781674
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of the present study is to evaluate the effectiveness of two doses of vaginal
      progesterone(200mg versus400mg) and placebo in improving gestational age in twin pregnancy
      and its subsequent impact on perinatal outcome.
The use of progesterone in the prevention of preterm birth(PTB) in both singleton and
      multiple pregnancies has been extensively investigated. Arguably, the use of progesterone is
      biologically plausible given that uterine quiescence is maintained throughout pregnancy by
      progesterone and progesterone receptor-mediated inhibition of inflammation, which causes
      suppression of the contractile genes. There is no benefit of universal vaginal progesterone
      to reduce PTB rates in multiple pregnancies. One meta-analysis showed a benefit in adverse
      perinatal outcome in a subgroup of women with a short cervix ≤25 mm, suggesting it may be
      useful in this group, but the numbers in the study were small and further research is needed.
      There appears to be no long-term harm caused to infants exposed to progesterone in utero. So
      the aim of the present study is to evaluate the effectiveness of two doses of vaginal
      progesterone(200mg versus400mg) and placebo in improving gestational age in twin pregnancy
      and its subsequent impact on perinatal outcome
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: a double-blind randomized controlled trial
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: a double-blind randomized controlled trial
measure: Preterm labor before 34 weeks gestations
time frame: Up to 34 weeks gestational age
description: Number of patients delivered before 34 weeks gestations
measure: Neonatal respiratory distress syndrome
time frame: At birth
description: Number of neonates develop respiratory distress syndrome
measure: Early neonatal death
time frame: One month after birth
description: number of neonates died within one month from birth
arm group label: progesterone 400mg
arm group type: Active Comparator
description: Women received vaginal progesterone suppositories in a dose of 400 mg(4 tablets) daily beginning at 18-22 weeks gestational age
arm group label: progesterone 200mg plus placebo to progesterone 200 mg
arm group type: Active Comparator
description: Women received vaginal progesterone suppositories in a dose of 200 mg(2 tablets) daily beginning at 18-22 weeks gestational age plus 2tablets placebo to vaginal progesterone
arm group label: placebo to progesterone 400 mg
arm group type: Placebo Comparator
description: Women received 4 tablets placebo to vaginal progesterone suppositories
intervention type: Drug
intervention name: progesterone 400mg
description: Women received vaginal progesterone suppositories in a dose of 400 mg daily beginning at 18-22 weeks gestational age
arm group label: progesterone 400mg
other name: Active Comparator
intervention type: Drug
intervention name: progesterone 200mg
description: Women received vaginal progesterone suppositories in a dose of 200 mg daily beginning at 18-22 weeks gestational age
arm group label: progesterone 200mg plus placebo to progesterone 200 mg
other name: Active Comparator
intervention type: Drug
intervention name: placebo to progesterone 200mg
description: Women received placebo to vaginal progesterone 200 mg suppositories in a dose of (2 tablets) daily beginning at 18-22 weeks gestational age
arm group label: placebo to progesterone 400 mg
arm group label: progesterone 200mg plus placebo to progesterone 200 mg
other name: Placebo comparator
intervention type: Drug
intervention name: placebo to progesterone 400mg
description: Women received placebo to vaginal progesterone 400 mg suppositories in a dose of (4 tablets) daily beginning at 18-22 weeks gestational age
arm group label: placebo to progesterone 400 mg
other name: placebo 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: Obstetric Labor, Premature
mesh term: Progesterone
sharing ipd: Undecided