<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/NCT03286998</url>
  </required_header>
  <id_info>
    <org_study_id>110149</org_study_id>
    <nct_id>NCT03286998</nct_id>
  </id_info>
  <brief_title>Ultrasound in Prediction of Operative Findings in Cesarean Section Among Placenta Accreta Cases</brief_title>
  <official_title>The Efficacy of Ultrasound in Predicting Operative Findings and Co-morbidities in Cesarean Section Among Cases of Placenta Accreta</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      A total of 60 women pregnant more than 28 weeks gestation will be recruited from obstetric&#xD;
      outpatient clinic (faculty of medicine -Cairo University Hospital) after being diagnosed of&#xD;
      having placenta previa or low lying placenta by grey scale ultrasound. Placenta will be&#xD;
      reexamined by grey scale ultrasound &amp; color Doppler. Sonographic parameters evaluated will&#xD;
      include placental location, loss of retro-placental clear zone, irregularity and thickness of&#xD;
      the uterine-placental interface, the smallest myometrial thickness in sagittal and transverse&#xD;
      planes, presence of lacunar spaces and bridging vessels &amp; the presence of abnormal&#xD;
      vasculature. The sonographic findings will be compared with intraoperative ones. Hysterectomy&#xD;
      specimen (if any was done) will be evaluated histo-pathologically to assess the degree of&#xD;
      placental invasion &amp; to confirm the accreta status. The aim of the study is to determine the&#xD;
      efficacy of ultrasound in predicting operative findings and associated co-morbidties among&#xD;
      cases of placenta accreta.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      60 pregnant women with singleton living healthy fetus diagnosed as having placenta previa by&#xD;
      grey scale ultrasound and candidate for repeated elective cesarean section (CS) or elective&#xD;
      cesarean hysterectomy (if the diagnosis of placenta accreta is confirmed) will be included in&#xD;
      the study. Inclusion criteria include: maternal age between 20 &amp; 40 years old, gestational&#xD;
      age more than 28 weeks (confirmed by a reliable date for the last menstrual period and 1st&#xD;
      trimester ultrasound scan), one or more cesarean section scar &amp; the presence of placenta&#xD;
      previa with high possibility of being placenta accreta when scanned by grey scale ultrasound.&#xD;
      Women who had chronic or pregnancy induced diseases or any emergency or unplanned CS will be&#xD;
      excluded. Informed consents will be obtained from all patients after explanation of the aim&#xD;
      of the study &amp; the potential risks. For all patients, full history will be taken followed by&#xD;
      complete physical examination &amp; routine obstetric ultrasound (to confirm the presence of&#xD;
      placenta previa i.e. placental tissue covers the internal cervical os or within 2 cm from&#xD;
      it). For all Participants, the placentae will be reexamined in systematic manner by&#xD;
      gray-scale &amp; color Doppler ultrasound via transabdominal and/or transvaginal approach using&#xD;
      Volusion Pro-V ultrasonography machine (GE Healthcare Austria GmbH, Seoul, Korea). All exams&#xD;
      will be done by expert sonographer &amp; the possibility of concomitant placenta accreta will be&#xD;
      checked. The placenta will be scanned with adequate bladder volume to visualize the bladder-&#xD;
      uterine serosal interface correctly &amp; the angle of insonation will kept as low as possible.&#xD;
      The presence of one or more of the following features in grey scale ultrasound will be&#xD;
      indicative of placenta accreta (presence of abnormal placental lacunae / complete loss of&#xD;
      retroplacental sonolucent zone / myometrial thinning / disruption of the uterine&#xD;
      serosa-bladder interface / presence of mass invading the urinary bladder). Similarly,&#xD;
      placenta accreta will be diagnosed by the presence of at least one of the following features&#xD;
      in color Doppler scan: diffuse or focal lacunar flow - sonolucent vascular lakes -&#xD;
      hypervascularity of the utero-vesical interface with bridging vessels connecting the placenta&#xD;
      to the bladder). The sonographic provisional diagnosis (i.e placenta previa, focal accreta,&#xD;
      accreta , increta or percreta) with the concomitant invasion of adjacent structures (e.g.,&#xD;
      the urinary bladder) will be documented. For all participants, termination of pregnancy will&#xD;
      be by elective CS or elective cesarean hysterectomy. Furthermore, operative findings as&#xD;
      regard the placenta and the invasion of adjacent structures will be documented. All operative&#xD;
      procedures will be done by senior staff obstetrician with special interest in placenta&#xD;
      accreta. For hysterectomy specimens, histopathological examination will be done to assess the&#xD;
      degree of myometrial invasion &amp; to confirm the diagnosis of placenta accreta. Maternal&#xD;
      morbidities (i.e. massive bleeding with the need of blood transfusion, pelvic organ injury or&#xD;
      ICU admission) or mortalities will be documented. Neonatal morbidities (i.e. prematurity or&#xD;
      NICU admission) or mortalities will be documented. The ultrasonographic findings will be&#xD;
      compared to operative details and histopathological reports. The aim of the study is to&#xD;
      evaluate the efficacy of ultrasound in predicting operative findings and associated&#xD;
      co-morbidities among cases of placenta accreta.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 20, 2017</start_date>
  <completion_date type="Anticipated">February 2021</completion_date>
  <primary_completion_date type="Anticipated">January 2021</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>the accuracy of ultrasound in predicting operative finding in cases of placenta accreta</measure>
    <time_frame>during cesarean section or elective cesarean hysterectomy</time_frame>
    <description>compare ultrasound report findings with the operative details report in hospital records</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Placenta Accreta</condition>
  <condition>Placenta Previa</condition>
  <arm_group>
    <arm_group_label>placenta previa</arm_group_label>
    <description>pregnant women with singleton living healthy fetus diagnosed as having placenta previa by grey scale ultrasound (placental tissue covers the internal cervical os or within 2 cm from it)</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        A total of 60 women pregnant more than 28 weeks gestation will be recruited from obstetric&#xD;
        outpatient clinic (faculty of medicine -Cairo University Hospital) after being diagnosed of&#xD;
        having placenta previa or low lying placenta by grey scale ultrasound.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Maternal age between 20 &amp; 40 years old&#xD;
&#xD;
          -  Singleton living healthy fetus.&#xD;
&#xD;
          -  Having placenta previa by grey scale ultrasound with high possibility of being&#xD;
             placenta accreta when scanned by grey scale ultrasound&#xD;
&#xD;
          -  Gestational age more than 28 weeks (confirmed by a reliable date for the last&#xD;
             menstrual period and 1st trimester ultrasound scan).&#xD;
&#xD;
          -  One or more cesarean section scar&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who had chronic or pregnancy induced diseases&#xD;
&#xD;
          -  Emergency or unplanned CS will be performed.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Moutaz Elsherbini, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistant professor of obstetrics and gynecology - Cairo university</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Moutaz Elsherbini, M.D.</last_name>
    <phone>(+2)01001588300</phone>
    <email>mizosherbini@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Marwa Eid, M.D</last_name>
    <phone>(+2)01001225079</phone>
    <email>marwaeid2014@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kasr Elainy Hospital (Cairo University)</name>
      <address>
        <city>Cairo</city>
        <zip>115431</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>moutaz elsherbini, M.D.</last_name>
      <phone>(+2)01001588300</phone>
      <email>mizosherbini@yahoo.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Faculty of medicine- Cairo university</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Moutaz Sherbini, MD</last_name>
      <phone>01001588300</phone>
      <email>mizosherbini@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>December 16, 2020</last_update_submitted>
  <last_update_submitted_qc>December 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Moutaz Sherbini</investigator_full_name>
    <investigator_title>assistant professor of obstetrics and gynecology</investigator_title>
  </responsible_party>
  <keyword>placenta previa</keyword>
  <keyword>color doppler</keyword>
  <keyword>placenta accreta</keyword>
  <keyword>ultrasonography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Placenta Accreta</mesh_term>
    <mesh_term>Placenta Previa</mesh_term>
  </condition_browse>
  <!-- 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/NCT03286998
org study id: 110149
nct id: NCT03286998
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A total of 60 women pregnant more than 28 weeks gestation will be recruited from obstetric
      outpatient clinic (faculty of medicine -Cairo University Hospital) after being diagnosed of
      having placenta previa or low lying placenta by grey scale ultrasound. Placenta will be
      reexamined by grey scale ultrasound & color Doppler. Sonographic parameters evaluated will
      include placental location, loss of retro-placental clear zone, irregularity and thickness of
      the uterine-placental interface, the smallest myometrial thickness in sagittal and transverse
      planes, presence of lacunar spaces and bridging vessels & the presence of abnormal
      vasculature. The sonographic findings will be compared with intraoperative ones. Hysterectomy
      specimen (if any was done) will be evaluated histo-pathologically to assess the degree of
      placental invasion & to confirm the accreta status. The aim of the study is to determine the
      efficacy of ultrasound in predicting operative findings and associated co-morbidties among
      cases of placenta accreta.
60 pregnant women with singleton living healthy fetus diagnosed as having placenta previa by
      grey scale ultrasound and candidate for repeated elective cesarean section (CS) or elective
      cesarean hysterectomy (if the diagnosis of placenta accreta is confirmed) will be included in
      the study. Inclusion criteria include: maternal age between 20 & 40 years old, gestational
      age more than 28 weeks (confirmed by a reliable date for the last menstrual period and 1st
      trimester ultrasound scan), one or more cesarean section scar & the presence of placenta
      previa with high possibility of being placenta accreta when scanned by grey scale ultrasound.
      Women who had chronic or pregnancy induced diseases or any emergency or unplanned CS will be
      excluded. Informed consents will be obtained from all patients after explanation of the aim
      of the study & the potential risks. For all patients, full history will be taken followed by
      complete physical examination & routine obstetric ultrasound (to confirm the presence of
      placenta previa i.e. placental tissue covers the internal cervical os or within 2 cm from
      it). For all Participants, the placentae will be reexamined in systematic manner by
      gray-scale & color Doppler ultrasound via transabdominal and/or transvaginal approach using
      Volusion Pro-V ultrasonography machine (GE Healthcare Austria GmbH, Seoul, Korea). All exams
      will be done by expert sonographer & the possibility of concomitant placenta accreta will be
      checked. The placenta will be scanned with adequate bladder volume to visualize the bladder-
      uterine serosal interface correctly & the angle of insonation will kept as low as possible.
      The presence of one or more of the following features in grey scale ultrasound will be
      indicative of placenta accreta (presence of abnormal placental lacunae / complete loss of
      retroplacental sonolucent zone / myometrial thinning / disruption of the uterine
      serosa-bladder interface / presence of mass invading the urinary bladder). Similarly,
      placenta accreta will be diagnosed by the presence of at least one of the following features
      in color Doppler scan: diffuse or focal lacunar flow - sonolucent vascular lakes -
      hypervascularity of the utero-vesical interface with bridging vessels connecting the placenta
      to the bladder). The sonographic provisional diagnosis (i.e placenta previa, focal accreta,
      accreta , increta or percreta) with the concomitant invasion of adjacent structures (e.g.,
      the urinary bladder) will be documented. For all participants, termination of pregnancy will
      be by elective CS or elective cesarean hysterectomy. Furthermore, operative findings as
      regard the placenta and the invasion of adjacent structures will be documented. All operative
      procedures will be done by senior staff obstetrician with special interest in placenta
      accreta. For hysterectomy specimens, histopathological examination will be done to assess the
      degree of myometrial invasion & to confirm the diagnosis of placenta accreta. Maternal
      morbidities (i.e. massive bleeding with the need of blood transfusion, pelvic organ injury or
      ICU admission) or mortalities will be documented. Neonatal morbidities (i.e. prematurity or
      NICU admission) or mortalities will be documented. The ultrasonographic findings will be
      compared to operative details and histopathological reports. The aim of the study is to
      evaluate the efficacy of ultrasound in predicting operative findings and associated
      co-morbidities among cases of placenta accreta.
observational model: Cohort
time perspective: Prospective
measure: the accuracy of ultrasound in predicting operative finding in cases of placenta accreta
time frame: during cesarean section or elective cesarean hysterectomy
description: compare ultrasound report findings with the operative details report in hospital records
arm group label: placenta previa
description: pregnant women with singleton living healthy fetus diagnosed as having placenta previa by grey scale ultrasound (placental tissue covers the internal cervical os or within 2 cm from it)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Moutaz Elsherbini, M.D
role: Principal Investigator
affiliation: Assistant professor of obstetrics and gynecology - Cairo university
last name: Moutaz Elsherbini, M.D.
phone: (+2)01001588300
email: mizosherbini@yahoo.com
last name: Marwa Eid, M.D
phone: (+2)01001225079
email: marwaeid2014@gmail.com
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Moutaz Sherbini
investigator title: assistant professor of obstetrics and gynecology
mesh term: Placenta Accreta
mesh term: Placenta Previa