<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/NCT04456660</url>
  </required_header>
  <id_info>
    <org_study_id>sFlt-1 in Abortion</org_study_id>
    <nct_id>NCT04456660</nct_id>
  </id_info>
  <brief_title>Risk Assessment and Prevention of Spontaneous Abortion</brief_title>
  <acronym>RAPSA</acronym>
  <official_title>Risk Assessment and Prevention of Spontaneous Abortion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Orthogyn Medical Center, Bulgaria</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Orthogyn Medical Center, Bulgaria</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to determine the role of sFlt-1 and placental bloodflow evaluation in the&#xD;
      detection of high risk for spontaneous abortion&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 20, 2020</start_date>
  <completion_date type="Anticipated">September 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 20, 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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Occurence of spontaneous abortion</measure>
    <time_frame>from 6th to 28th week of gestation</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Spontaneous Abortion</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>sFlt-1 &amp; Doppler group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>sFlt-1 measurement &amp; placental Doppler</intervention_name>
    <description>Measurement of sFlt-1 levels in maternal blood as a potential inflammation indicator. Investigating the levels of placental circulation.</description>
    <arm_group_label>sFlt-1 &amp; Doppler group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  visualized fetal structures in utero &amp; heart pulsations until 8th week of gestation&#xD;
&#xD;
          -  normal THS/T4 levels&#xD;
&#xD;
          -  no uterine malformations&#xD;
&#xD;
          -  no submucous fibroids and/or endometrial polyps&#xD;
&#xD;
          -  BMI &lt; 27&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  fetal structures in utero &amp; heart pulsations not visualized until 8th week of&#xD;
             gestation&#xD;
&#xD;
          -  elevated THS/T4 levels&#xD;
&#xD;
          -  uterine malformations&#xD;
&#xD;
          -  submucous fibroids and/or endometrial polyps&#xD;
&#xD;
          -  BMI &gt; 27&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Petar N Ignatov, PhD</last_name>
    <phone>0035988896318</phone>
    <phone_ext>00359</phone_ext>
    <email>ignatov@orthogyn.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Orthogyn Medical and Dental Center</name>
      <address>
        <city>Sofia</city>
        <zip>1618</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Petar D Ignatov, PhD</last_name>
      <phone>00359888963189</phone>
      <phone_ext>00359</phone_ext>
      <email>ignatov@orthogyn.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Bulgaria</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>June 29, 2020</last_update_submitted>
  <last_update_submitted_qc>June 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Orthogyn Medical Center, Bulgaria</investigator_affiliation>
    <investigator_full_name>Petar Ignatov</investigator_full_name>
    <investigator_title>Assist. Prof. Petar Ignatov, MD, Ph.D.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abortion, Spontaneous</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/NCT04456660
org study id: sFlt-1 in Abortion
nct id: NCT04456660
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study aims to determine the role of sFlt-1 and placental bloodflow evaluation in the
      detection of high risk for spontaneous abortion
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Occurence of spontaneous abortion
time frame: from 6th to 28th week of gestation
arm group label: Control group
arm group type: No Intervention
arm group label: sFlt-1 & Doppler group
arm group type: Active Comparator
intervention type: Procedure
intervention name: sFlt-1 measurement & placental Doppler
description: Measurement of sFlt-1 levels in maternal blood as a potential inflammation indicator. Investigating the levels of placental circulation.
arm group label: sFlt-1 & Doppler group
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Petar N Ignatov, PhD
phone: 0035988896318
phone ext: 00359
email: ignatov@orthogyn.com
facility: 
status: Recruiting
contact: 
country: Bulgaria
responsible party type: Principal Investigator
investigator affiliation: Orthogyn Medical Center, Bulgaria
investigator full name: Petar Ignatov
investigator title: Assist. Prof. Petar Ignatov, MD, Ph.D.
mesh term: Abortion, Spontaneous
sharing ipd: Undecided