<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/NCT03761888</url>
  </required_header>
  <id_info>
    <org_study_id>2018-A00689-46</org_study_id>
    <nct_id>NCT03761888</nct_id>
  </id_info>
  <brief_title>Nicardipine and Labetalol Effects on Cerebral Hemodynamics in Preeclampsia</brief_title>
  <acronym>PREMODYM</acronym>
  <official_title>How Nicardipine and Labetalol Affect Cerebral Hemodynamics in Severe Preeclamptic Patients: A Pilot Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hopital Antoine Beclere</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hopital Antoine Beclere</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Realization of transcranial doppler and optic nerve sheath in severe preeclamptic patients to&#xD;
      evaluate the impact of nicardipine and labetalol on cerebral hemodynamics.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 29, 2018</start_date>
  <completion_date type="Anticipated">May 2019</completion_date>
  <primary_completion_date type="Anticipated">May 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Change of values obtained by ultrasonography optic nerve sheath measurement from baseline to 2 hours post starting infusion of nicardipine or labetalol.</measure>
    <time_frame>just before treatment and 2 hours after</time_frame>
    <description>Variation of values will be studied during a 2 hour time period, starting just before administration of either labetalol or nicardipine by i.v. route</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>variation of diastolic and systolic velocities in middle cerebral artery before and after administration of either labetalol or nicardipine by i.v. route</measure>
    <time_frame>just before treatment and at 30 minutes to 60 minutes, 2 hours to 3 hours and 6 hours to 8 hours</time_frame>
    <description>values are obtained by transcranial doppler</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>variation of PI in middle cerebral artery before and after administration of either labetalol or nicardipine by i.v. route</measure>
    <time_frame>just before treatment and at 30 minutes to 60 minutes, 2 hours to 3 hours and 6 hours to 8 hours</time_frame>
    <description>values are obtained by transcranial doppler</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>proportion of pathologic PI in middle cerebral artery in each group</measure>
    <time_frame>just before treatment and at 30 minutes to 60 minutes, 2 hours to 3 hours and 6 hours to 8 hours</time_frame>
    <description>values are obtained by transcranial doppler</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>proportion of optic nerve sheath up to 5.8 mm in each group</measure>
    <time_frame>just before treatment and at 30 minutes to 60 minutes, 2 hours to 3 hours and 6 hours to 8 hours</time_frame>
    <description>values are obtained by ultrasonography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>values of optic nerve sheath diameter in each group</measure>
    <time_frame>At 30 minutes to 60 minutes and 6 hours to 8 hours</time_frame>
    <description>values are obtained by ultrasonography</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Preeclampsia Severe</condition>
  <arm_group>
    <arm_group_label>Labetalol</arm_group_label>
    <description>Patients who will receive labetalol in IV route in first intention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nicardipine</arm_group_label>
    <description>Patients who will receive nicardipine in IV route in first intention</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>optic nerve sheath measurement and transcranial doppler</intervention_name>
    <description>evaluation of cerebral hemodynamics through measurement of systolic and diastolic velocities and PI in middle cerebral artery. Intracranial pressure will be appreciate by optic nerve sheath value</description>
    <arm_group_label>Labetalol</arm_group_label>
    <arm_group_label>Nicardipine</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        women with severe preeclampsia and antihypertensive drug administrated by i.v. route&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged up to 18 years&#xD;
&#xD;
          -  patient with severe preeclampsia defined by Systolic blood pressure ≥ 140 mmHg and/or&#xD;
             diastolic blood pressure ≥ 90 mmHg after 20 weeks of amenorrhea, associated with&#xD;
             neurologic troubles, eclampsia of epigastric pain.&#xD;
&#xD;
          -  Decision by clinician to introduce an antihypertensive therapy by oral route : either&#xD;
             labetalol or nicardipine&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of intracranial expansive processus, surgery or vascular disease&#xD;
&#xD;
          -  infectious state on probe placement&#xD;
&#xD;
          -  unilateral anophthalmia&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mickaël SOUED</last_name>
    <phone>+33145374273</phone>
    <email>mickael.soued@aphp.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hôpital Béclère</name>
      <address>
        <city>Clamart</city>
        <zip>92140</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mickaël SOUED</last_name>
      <phone>+33145374273</phone>
      <email>mickael.soued@aphp.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>November 30, 2018</last_update_submitted>
  <last_update_submitted_qc>November 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hopital Antoine Beclere</investigator_affiliation>
    <investigator_full_name>Dr Mickaël Soued</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pre-Eclampsia</mesh_term>
  </condition_browse>
  <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/NCT03761888
org study id: 2018-A00689-46
nct id: NCT03761888
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Realization of transcranial doppler and optic nerve sheath in severe preeclamptic patients to
      evaluate the impact of nicardipine and labetalol on cerebral hemodynamics.
observational model: Other
time perspective: Prospective
measure: Change of values obtained by ultrasonography optic nerve sheath measurement from baseline to 2 hours post starting infusion of nicardipine or labetalol.
time frame: just before treatment and 2 hours after
description: Variation of values will be studied during a 2 hour time period, starting just before administration of either labetalol or nicardipine by i.v. route
measure: variation of diastolic and systolic velocities in middle cerebral artery before and after administration of either labetalol or nicardipine by i.v. route
time frame: just before treatment and at 30 minutes to 60 minutes, 2 hours to 3 hours and 6 hours to 8 hours
description: values are obtained by transcranial doppler
measure: variation of PI in middle cerebral artery before and after administration of either labetalol or nicardipine by i.v. route
time frame: just before treatment and at 30 minutes to 60 minutes, 2 hours to 3 hours and 6 hours to 8 hours
description: values are obtained by transcranial doppler
measure: proportion of pathologic PI in middle cerebral artery in each group
time frame: just before treatment and at 30 minutes to 60 minutes, 2 hours to 3 hours and 6 hours to 8 hours
description: values are obtained by transcranial doppler
measure: proportion of optic nerve sheath up to 5.8 mm in each group
time frame: just before treatment and at 30 minutes to 60 minutes, 2 hours to 3 hours and 6 hours to 8 hours
description: values are obtained by ultrasonography
measure: values of optic nerve sheath diameter in each group
time frame: At 30 minutes to 60 minutes and 6 hours to 8 hours
description: values are obtained by ultrasonography
arm group label: Labetalol
description: Patients who will receive labetalol in IV route in first intention
arm group label: Nicardipine
description: Patients who will receive nicardipine in IV route in first intention
intervention type: Diagnostic Test
intervention name: optic nerve sheath measurement and transcranial doppler
description: evaluation of cerebral hemodynamics through measurement of systolic and diastolic velocities and PI in middle cerebral artery. Intracranial pressure will be appreciate by optic nerve sheath value
arm group label: Labetalol
arm group label: Nicardipine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mickaël SOUED
phone: +33145374273
email: mickael.soued@aphp.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Hopital Antoine Beclere
investigator full name: Dr Mickaël Soued
investigator title: Principal Investigator
mesh term: Pre-Eclampsia
sharing ipd: No