<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/NCT03032770</url>
  </required_header>
  <id_info>
    <org_study_id>USPA</org_study_id>
    <nct_id>NCT03032770</nct_id>
  </id_info>
  <brief_title>Early Prediction of Placenta Accreta by Ultrasound and Color Doppler</brief_title>
  <official_title>Early Prediction of Placenta Accreta by 2 Dimensional Transvaginal Ultrasound and Color Doppler</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Placenta accreta is a substantially life threatening condition and one of the causes of&#xD;
      maternal morbidity and mortality in the world. According to study done in United Kingdom, The&#xD;
      estimated incidence of placenta accreta/increta/percreta was 1.7 per 10,000 maternities&#xD;
      overall and 577 per 10,000 in women with both a previous cesarean delivery and placenta&#xD;
      previa. in a tertiary south Italian center, The incidence increased from 0.12% during the&#xD;
      1970s, to 0.31% during the 2000s.While in United States of America, the prevalence of&#xD;
      placenta accreta was 3.7 per 1000 deliveries.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">March 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Confirmation of occurrence of placenta accreta during delivery.</measure>
    <time_frame>duration of pregnancy</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">148</enrollment>
  <condition>Placenta Accreta</condition>
  <arm_group>
    <arm_group_label>placenta accreta</arm_group_label>
    <description>Having at least one sign suggestive of placenta accreta</description>
  </arm_group>
  <arm_group>
    <arm_group_label>normal placenta</arm_group_label>
    <description>Never having any of the signs suggestive of placenta accreta</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>two-dimensional ultrasound and color Doppler</intervention_name>
    <description>the eligible participants will be searched for signs suggestive of placenta accreta; low implantation of the gestational sac (&lt;4cm from the external os), presence of placental lakes, Disruption of placental-myometrial interface and trophoblast overlapping a uterine scar by 2 dimensional transvaginal ultrasound and Intraplacental dilated vessels, turbulent blood flows and greatly increased periplacental vascularity by Doppler ultrasound by level II sonographer and co-investigator under his supervision using ultrasound device.</description>
    <arm_group_label>normal placenta</arm_group_label>
    <arm_group_label>placenta accreta</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        first trimester pregnancy between 11 weeks and 13 weeks.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Low implantation of the gestational sac (&lt;4 cm from external os) by transvaginal&#xD;
             ultrasound&#xD;
&#xD;
          2. Presence of placental lakes by transvaginal ultrasound&#xD;
&#xD;
          3. Disruption of placental-myometrial interface by transvaginal ultrasound&#xD;
&#xD;
          4. Trophoblast overlapping a uterine scar (Cesarean section, myomectomy) by transvaginal&#xD;
             ultrasound&#xD;
&#xD;
          5. Intraplacental dilated vessels by Doppler ultrasound&#xD;
&#xD;
          6. Turbulent blood flows by Doppler ultrasound&#xD;
&#xD;
          7. Greatly increased periplacental vascularity by Doppler ultrasound&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        a) Cases far away from our hospital and expected to be lost to be followed. b) Pregnant&#xD;
        women who will refuse to Participate&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Assiut University</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>May 11, 2020</last_update_submitted>
  <last_update_submitted_qc>May 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Ahmed Mohamed Abbas</investigator_full_name>
    <investigator_title>clinical professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Placenta Accreta</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/NCT03032770
org study id: USPA
nct id: NCT03032770
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Placenta accreta is a substantially life threatening condition and one of the causes of
      maternal morbidity and mortality in the world. According to study done in United Kingdom, The
      estimated incidence of placenta accreta/increta/percreta was 1.7 per 10,000 maternities
      overall and 577 per 10,000 in women with both a previous cesarean delivery and placenta
      previa. in a tertiary south Italian center, The incidence increased from 0.12% during the
      1970s, to 0.31% during the 2000s.While in United States of America, the prevalence of
      placenta accreta was 3.7 per 1000 deliveries.
observational model: Cohort
time perspective: Prospective
measure: Confirmation of occurrence of placenta accreta during delivery.
time frame: duration of pregnancy
arm group label: placenta accreta
description: Having at least one sign suggestive of placenta accreta
arm group label: normal placenta
description: Never having any of the signs suggestive of placenta accreta
intervention type: Device
intervention name: two-dimensional ultrasound and color Doppler
description: the eligible participants will be searched for signs suggestive of placenta accreta; low implantation of the gestational sac (<4cm from the external os), presence of placental lakes, Disruption of placental-myometrial interface and trophoblast overlapping a uterine scar by 2 dimensional transvaginal ultrasound and Intraplacental dilated vessels, turbulent blood flows and greatly increased periplacental vascularity by Doppler ultrasound by level II sonographer and co-investigator under his supervision using ultrasound device.
arm group label: normal placenta
arm group label: placenta accreta
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Ahmed Mohamed Abbas
investigator title: clinical professor
mesh term: Placenta Accreta
sharing ipd: Undecided