<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/NCT03838887</url>
  </required_header>
  <id_info>
    <org_study_id>placental vascular indices</org_study_id>
    <nct_id>NCT03838887</nct_id>
  </id_info>
  <brief_title>Comparison Between Uterine Artery Doppler and Placental Vascular Indices in Prediction of Preeclampsia</brief_title>
  <official_title>Comparison Between Uterine Artery Doppler and Placental Vascular Indices in Prediction of Preeclampsia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Research Centre, Egypt</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Research Centre, Egypt</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>
      • Preeclampsia is a multisystem disorder that can cause considerable maternal and fetal&#xD;
      morbidity and mortality. Late preeclampsia (with delivery &gt;34 weeks) is more frequent and&#xD;
      less serious than early preeclampsia (with delivery &lt;34 weeks). Poor early placentation has&#xD;
      been especially associated with early disease. Early identification of women at risk of&#xD;
      preeclampsia is currently a crucial aim of antenatal care since they may benefit from&#xD;
      prophylactic treatment and increased surveillance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  The introduction of three-dimensional (3D) ultrasound techniques, with the option of&#xD;
           calculating placental volume and measuring vascular indices, has created an excellent&#xD;
           opportunity to study early changes in the uteroplacental circulation space, which&#xD;
           includes the maternal spiral arteries and the intervillous space. This technology may&#xD;
           allow a more direct evaluation of the abnormal placentation process thought to herald&#xD;
           the development of preeclampsia.&#xD;
&#xD;
        -  The aim of this study was to assess the usefulness of placental volume and 3D vascular&#xD;
           indices as reliable predictors of early preeclampsia in comparison to uterine artery&#xD;
           Doppler&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2021</start_date>
  <completion_date type="Anticipated">January 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>placental vascular indices in prediction of preeclampsia</measure>
    <time_frame>one year</time_frame>
    <description>placental vascular indices in prediction of preeclampsia compared to uterine artery doppler in prediction of preeclampsia</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Pre-Eclampsia</condition>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <description>Pregnant women:&#xD;
Age between 18-35 years&#xD;
Parity: primigravidas and multiparas.&#xD;
Have no history of preeclampsia or eclampsia.&#xD;
Have no history of chronic hypertension.&#xD;
Not diabetic.&#xD;
Not have antiphospholipid syndrome.&#xD;
Not have autoimmune disease such as SLE</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High risk group</arm_group_label>
    <description>Pregnant women with:&#xD;
History of preeclampsia -Eclapmsia&#xD;
Chronic hypertension&#xD;
Diabetic&#xD;
Antiphospholipid syndrome.&#xD;
Autoimmune syndrome such as SLE.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ultrasound machine</intervention_name>
    <description>Ultrasound machine with a vocal software</description>
    <arm_group_label>High risk group</arm_group_label>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All pregnant women will be examined for antenatal care in the outpatient clinic and fetal&#xD;
        medicine unit of obstetrics and gynecology department then they will be divided into two&#xD;
        groups control and high risk&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A. Control group: Pregnant women:&#xD;
&#xD;
               1. Age between 18-35 years&#xD;
&#xD;
               2. Parity: primigravidas and multiparas.&#xD;
&#xD;
               3. Have no history of preeclampsia or eclampsia.&#xD;
&#xD;
               4. Have no history of chronic hypertension.&#xD;
&#xD;
               5. Not diabetic.&#xD;
&#xD;
               6. Not have antiphospholipid syndrome.&#xD;
&#xD;
               7. Not have autoimmune disease such as SLE.&#xD;
&#xD;
        B. High risk group: Pregnant women with:&#xD;
&#xD;
          1. History of preeclampsia -Eclapmsia&#xD;
&#xD;
          2. Chronic hypertension&#xD;
&#xD;
          3. Diabetic&#xD;
&#xD;
          4. Antiphospholipid syndrome.&#xD;
&#xD;
          5. Autoimmune syndrome such as SLE.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Smoking&#xD;
&#xD;
               -  Dichorionic placentae&#xD;
&#xD;
               -  Fetal anomaly&#xD;
&#xD;
               -  Uterine fibroid at the site of placental implantation&#xD;
&#xD;
               -  Subchorionic hematoma&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>examination of pregnant women</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>SHERIF MOHAMMED ELSIRGANY, DOCTOR</last_name>
    <phone>+201223607191</phone>
    <email>SHERIFELSIRGANY@YAHOO.COM</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Research Centre</name>
      <address>
        <city>Cairo</city>
        <zip>1234</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>SHERIF MOHAMMED ELSIRGANY, DOCTOR</last_name>
      <phone>+01223607191</phone>
      <email>SHERIFELSIRGANY@YAHOO.COM</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>February 3, 2019</study_first_submitted>
  <study_first_submitted_qc>February 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>August 11, 2021</last_update_submitted>
  <last_update_submitted_qc>August 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Research Centre, Egypt</investigator_affiliation>
    <investigator_full_name>Sherif Elsirgany</investigator_full_name>
    <investigator_title>Researcher ,Family Planning and Reproductive Health Department</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pre-Eclampsia</mesh_term>
    <mesh_term>Eclampsia</mesh_term>
  </condition_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/NCT03838887
org study id: placental vascular indices
nct id: NCT03838887
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
• Preeclampsia is a multisystem disorder that can cause considerable maternal and fetal
      morbidity and mortality. Late preeclampsia (with delivery >34 weeks) is more frequent and
      less serious than early preeclampsia (with delivery <34 weeks). Poor early placentation has
      been especially associated with early disease. Early identification of women at risk of
      preeclampsia is currently a crucial aim of antenatal care since they may benefit from
      prophylactic treatment and increased surveillance.
-  The introduction of three-dimensional (3D) ultrasound techniques, with the option of
           calculating placental volume and measuring vascular indices, has created an excellent
           opportunity to study early changes in the uteroplacental circulation space, which
           includes the maternal spiral arteries and the intervillous space. This technology may
           allow a more direct evaluation of the abnormal placentation process thought to herald
           the development of preeclampsia.

        -  The aim of this study was to assess the usefulness of placental volume and 3D vascular
           indices as reliable predictors of early preeclampsia in comparison to uterine artery
           Doppler
observational model: Case-Control
time perspective: Prospective
measure: placental vascular indices in prediction of preeclampsia
time frame: one year
description: placental vascular indices in prediction of preeclampsia compared to uterine artery doppler in prediction of preeclampsia
arm group label: control group
description: Pregnant women:
Age between 18-35 years
Parity: primigravidas and multiparas.
Have no history of preeclampsia or eclampsia.
Have no history of chronic hypertension.
Not diabetic.
Not have antiphospholipid syndrome.
Not have autoimmune disease such as SLE
arm group label: High risk group
description: Pregnant women with:
History of preeclampsia -Eclapmsia
Chronic hypertension
Diabetic
Antiphospholipid syndrome.
Autoimmune syndrome such as SLE.
intervention type: Device
intervention name: ultrasound machine
description: Ultrasound machine with a vocal software
arm group label: High risk group
arm group label: control group
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: examination of pregnant women
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: SHERIF MOHAMMED ELSIRGANY, DOCTOR
phone: +201223607191
email: SHERIFELSIRGANY@YAHOO.COM
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: National Research Centre, Egypt
investigator full name: Sherif Elsirgany
investigator title: Researcher ,Family Planning and Reproductive Health Department
mesh term: Pre-Eclampsia
mesh term: Eclampsia
sharing ipd: Undecided