xml: <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/NCT05972915</url>
    </required_header>
    <id_info>
      <org_study_id>Separation sign</org_study_id>
      <nct_id>NCT05972915</nct_id>
    </id_info>
    <brief_title>Separation Sign: New Ultrasound Sign to Rule Out Placenta Accreta</brief_title>
    <official_title>Separation Sign: New Ultrasound Sign to Rule Out Diagnosis of Placenta Accreta</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Beni-Suef University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Beni-Suef University</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>
        To assess the 'separation sign' as a predictor of normal placental separation in a large&#xD;
        cohort of women at risk for placenta accrete spectrum and in a high-risk subgroup with&#xD;
        placenta previa or anterior low-lying placenta and have history of at least one previous&#xD;
        Cesarean delivery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A prospective Observational Cohort study The study population includes high-risk cohort of&#xD;
        women was defined as those who had placenta previa or an anterior low-lying placenta, in&#xD;
        addition to at least one previous Cesarean delivery. They will be asked to participate in the&#xD;
        study after been evaluated to ensure fulfilling inclusion and exclusion criteria.&#xD;
  &#xD;
        Women will be enrolled in the study after giving written informed consent&#xD;
  &#xD;
        The patients will be submitted to:&#xD;
  &#xD;
        **Full history taking including: Details of gestational age at the time of scanning, maternal&#xD;
        age and risk factors , history of dilatation and curettage, in-vitro fertilization and other&#xD;
        previous uterine surgery were assessed.&#xD;
  &#xD;
        ***Detailed trans-abdominal sonographic examination of the placenta was performed, assessing&#xD;
        standard ultrasound markers of PAS. Two experienced sonographic operators performed all&#xD;
        examinations using (Toshiba Xario 200) with 3D/4D curved-array trans-abdominal transducer&#xD;
        (4-8.5 MHz). All examinations were performed with a full bladder, defined as a volume between&#xD;
        250mL 500mL quantified using the inbuilt ellipsoid volume calculation.&#xD;
  &#xD;
        To assess for the separation sign, pressure was applied using an ultrasound probe so that the&#xD;
        hypoechoic retroplacental clear zone normally observed between the placenta and myometrium&#xD;
        disappeared. The pressure was then rapidly released in order to generate the force required&#xD;
        to see movement. On release, in cases with normal placentation, the non-elastic placenta&#xD;
        keeps moving away from the probe after the highly elastic myometrium has 'snapped' back into&#xD;
        place. This sometimes causes the placenta either to keep moving briefly or even to 'bounce'&#xD;
        and leads to the appearance or enhancement of the clear zone. With a negative separation&#xD;
        sign, no separate movement of the placenta from the myometrium can be seen. The separation&#xD;
        sign was recorded as positive if separation of the myometrium from the placenta was observed&#xD;
        in all areas of the placenta. The sign was recorded as negative if the myometrium and&#xD;
        placenta moved as one structure and no clear zone could be seen over any part of the placenta&#xD;
        after release, even if separation was noted at the margins of the placenta. Classification&#xD;
        into positive or negative separation sign was highly stringent and, in case of any doubt, the&#xD;
        result was recorded as uncertain. The latter occurred most often when the images obtained&#xD;
        were suboptimal, for example, owing to tissue attenuation, high body mass index (BMI) or&#xD;
        significant scarring. If women were scanned on multiple occasions, the separation sign result&#xD;
        obtained closest to 28 weeks' gestation was used in order to minimize differences in scanning&#xD;
        over the course of gestation.&#xD;
  &#xD;
        ***Based on histopathology results in cases in which hysterectomy was performed. A diagnosis&#xD;
        of PAS was excluded if the placenta separated spontaneously at delivery, was delivered by&#xD;
        controlled cord traction or was delivered by simple manual removal. Histopathological&#xD;
        analysis was carried out by a pathologist with expertise in PAS, with the specific sampling&#xD;
        site marked by the surgical team according to intrapartum findings. The pathologists were&#xD;
        blinded to the separation sign classification but not to surgical findings.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 30, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2023</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>separation sign</measure>
      <time_frame>1 month before delivery</time_frame>
      <description>The separation sign was recorded as positive if separation of the myometrium from the placenta was observed in all areas of the placenta. The sign was recorded as negative if the myometrium and placenta moved as one structure and no clear zone could be seen over any part of the placenta after release, even if separation was noted at the margins of the placenta.</description>
    </primary_outcome>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Accreta, Placenta</condition>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Separation sign</intervention_name>
      <description>The separation sign was recorded as positive if separation of the myometrium from the placenta was observed in all areas of the placenta. The sign was recorded as negative if the myometrium and placenta moved as one structure and no clear zone could be seen over any part of the placenta after release, even if separation was noted at the margins of the placenta.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The study population includes high-risk cohort of women was defined as those who had&#xD;
          placenta previa or an anterior low-lying placenta, in addition to at least one previous&#xD;
          Cesarean delivery.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  History of previous cesarean section or hysterotomy.&#xD;
  &#xD;
                 -  Placenta previa or low lying anterior placenta.&#xD;
  &#xD;
                 -  From 28 wks to Full term.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Multiple pregnancies.&#xD;
  &#xD;
            2. Medical disorder as diabetes mellitus, hypertension. 3. Obese patients. BMI &gt; 30 4.&#xD;
               Intrauterine growth retardation.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Beni-suef University</last_name>
      <phone>082 2318605</phone>
      <phone_ext>02</phone_ext>
      <email>fom@med.bsu.edu.eg</email>
    </overall_contact>
    <location>
      <facility>
        <name>Beni-suef university Hospital</name>
        <address>
          <city>Banī Suwayf</city>
          <state>Beni Suef</state>
          <zip>62521</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Beni-Suef University</investigator_affiliation>
      <investigator_full_name>Sara Abdallah Mohamed Salem</investigator_full_name>
      <investigator_title>principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University</investigator_title>
    </responsible_party>
    <keyword>placenta accreta</keyword>
    <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>
  
  
text: 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/NCT05972915
  org study id: Separation sign
  nct id: NCT05972915
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To assess the 'separation sign' as a predictor of normal placental separation in a large
        cohort of women at risk for placenta accrete spectrum and in a high-risk subgroup with
        placenta previa or anterior low-lying placenta and have history of at least one previous
        Cesarean delivery.
  A prospective Observational Cohort study The study population includes high-risk cohort of
        women was defined as those who had placenta previa or an anterior low-lying placenta, in
        addition to at least one previous Cesarean delivery. They will be asked to participate in the
        study after been evaluated to ensure fulfilling inclusion and exclusion criteria.
  
        Women will be enrolled in the study after giving written informed consent
  
        The patients will be submitted to:
  
        **Full history taking including: Details of gestational age at the time of scanning, maternal
        age and risk factors , history of dilatation and curettage, in-vitro fertilization and other
        previous uterine surgery were assessed.
  
        ***Detailed trans-abdominal sonographic examination of the placenta was performed, assessing
        standard ultrasound markers of PAS. Two experienced sonographic operators performed all
        examinations using (Toshiba Xario 200) with 3D/4D curved-array trans-abdominal transducer
        (4-8.5 MHz). All examinations were performed with a full bladder, defined as a volume between
        250mL 500mL quantified using the inbuilt ellipsoid volume calculation.
  
        To assess for the separation sign, pressure was applied using an ultrasound probe so that the
        hypoechoic retroplacental clear zone normally observed between the placenta and myometrium
        disappeared. The pressure was then rapidly released in order to generate the force required
        to see movement. On release, in cases with normal placentation, the non-elastic placenta
        keeps moving away from the probe after the highly elastic myometrium has 'snapped' back into
        place. This sometimes causes the placenta either to keep moving briefly or even to 'bounce'
        and leads to the appearance or enhancement of the clear zone. With a negative separation
        sign, no separate movement of the placenta from the myometrium can be seen. The separation
        sign was recorded as positive if separation of the myometrium from the placenta was observed
        in all areas of the placenta. The sign was recorded as negative if the myometrium and
        placenta moved as one structure and no clear zone could be seen over any part of the placenta
        after release, even if separation was noted at the margins of the placenta. Classification
        into positive or negative separation sign was highly stringent and, in case of any doubt, the
        result was recorded as uncertain. The latter occurred most often when the images obtained
        were suboptimal, for example, owing to tissue attenuation, high body mass index (BMI) or
        significant scarring. If women were scanned on multiple occasions, the separation sign result
        obtained closest to 28 weeks' gestation was used in order to minimize differences in scanning
        over the course of gestation.
  
        ***Based on histopathology results in cases in which hysterectomy was performed. A diagnosis
        of PAS was excluded if the placenta separated spontaneously at delivery, was delivered by
        controlled cord traction or was delivered by simple manual removal. Histopathological
        analysis was carried out by a pathologist with expertise in PAS, with the specific sampling
        site marked by the surgical team according to intrapartum findings. The pathologists were
        blinded to the separation sign classification but not to surgical findings.
  observational model: Cohort
  time perspective: Prospective
  measure: separation sign
  time frame: 1 month before delivery
  description: The separation sign was recorded as positive if separation of the myometrium from the placenta was observed in all areas of the placenta. The sign was recorded as negative if the myometrium and placenta moved as one structure and no clear zone could be seen over any part of the placenta after release, even if separation was noted at the margins of the placenta.
  intervention type: Diagnostic Test
  intervention name: Separation sign
  description: The separation sign was recorded as positive if separation of the myometrium from the placenta was observed in all areas of the placenta. The sign was recorded as negative if the myometrium and placenta moved as one structure and no clear zone could be seen over any part of the placenta after release, even if separation was noted at the margins of the placenta.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  minimum age: 20 Years
  maximum age: 40 Years
  last name: Beni-suef University
  phone: 082 2318605
  phone ext: 02
  email: fom@med.bsu.edu.eg
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Beni-Suef University
  investigator full name: Sara Abdallah Mohamed Salem
  investigator title: principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University
  mesh term: Placenta Accreta
  sharing ipd: Undecided