<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/NCT03813212</url>
  </required_header>
  <id_info>
    <org_study_id>MRI placenta accreta</org_study_id>
    <nct_id>NCT03813212</nct_id>
  </id_info>
  <brief_title>Magnetic Resonance Imaging (MRI ) Versus Ultrasound in Placenta Accreta Diagnosis</brief_title>
  <official_title>Gray-scale , Colour Doppler Ultrasound and Magnetic Resonance Imaging for Diagnosis of Placenta Accreta</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams 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>
      This study aim to assess the accuracy of magnetic resonance imaging (MRI) compared to&#xD;
      gray-scale and colour Doppler ultrasound (US) for the prenatal diagnosis of placenta accreta.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Placenta accreta occurs when the chorionic villi abnormally invade the myometrium. Based on&#xD;
      histopathology it is divided into three grades: placenta accreta (the chorionic villi are in&#xD;
      contact with the myometrium), placenta increta (the chorionic villi invade the myometrium),&#xD;
      and placenta percreta where the chorionic villi penetrate the uterine serosa. With increasing&#xD;
      rate of cesarean delivery, the incidence of both placenta praevia and placenta accreta is&#xD;
      steadily increasing in frequency.&#xD;
&#xD;
      Prenatal diagnosis of invasive placentation is associated with a reduced risk of maternal&#xD;
      complications as it allows a preplanned treatment of the condition . Gray-scale and colour&#xD;
      Doppler ultrasound (US) are valuable tools in the prenatal diagnosis of placenta accreta&#xD;
      .However, if the ultrasound ( US ) findings suggest possible percreta or are inconclusive or&#xD;
      negative in an at-risk woman, magnetic resonance imaging (MRI) can be useful.&#xD;
&#xD;
      Multiple sonographic findings are seen with placenta accreta such as decrease in myometrial&#xD;
      thickness, placenta previa, placental lacunae, abnormal pattern of color Doppler, loss of the&#xD;
      retroplacental clear zone and placenta percreta irregularities in wall of urinary bladder (&#xD;
      UB ) have been detected .&#xD;
&#xD;
      The most magnetic resonance imaging characteristic findings seen in placenta accreta are&#xD;
      nodular thickening in the dark zone of placenta-uterine interface together with extensions of&#xD;
      dark bands through the placenta, outer uterine bulge causing from the mass effect of the&#xD;
      placenta and heterogeneous signal intensity of placenta on the T2-weighted HASTE sequences&#xD;
      due to large placental lakes and vessels.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">January 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>Determination of degree of placental invasion</measure>
    <time_frame>Baseline</time_frame>
    <description>Determination of degree of placental invasion by comparing the results obtained by ultrasound , MRI with the final pathological examination after operation ( the excised part of myometrium with the attached placenta or hysterectomy specimen ).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change Maternal morbidity and mortality</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Placenta Accreta, Third Trimester</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MRI</intervention_name>
    <description>Magnetic resonance imaging. Trans-abdominal sonography (TAS) and transvaginal sonography (TVS) will be performed using a 3.5 or 5 MHz transabdominal convex transducer and a 7 MHz trans-vaginal transducer.</description>
    <other_name>Ultrasound</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Haemodynamically stable pregnant women, who attend the antenatal care clinic at Ain Shams&#xD;
        University Hospital or are referred from other hospitals for further evaluation. The&#xD;
        recruited patients have to fulfill the inclusion criteria,&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Haemodynamically stable pregnant women who have the following risk factors for&#xD;
             placenta accreta : persistent anterior placenta previa, prior uterine surgery (such as&#xD;
             a previous cesarean section, uterine curettage, or myomectomy).&#xD;
&#xD;
          -  Maternal age : 20-40 years old.&#xD;
&#xD;
          -  BMI : 18-29.9 kg/m2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria will be MRI contraindications, cardiac pacemaker, metal objects in&#xD;
             the body, and patient's refusal for MRI evaluation.&#xD;
&#xD;
          -  Haemodynamically unstable patients.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Safaa Thabet, M.B.B.,Ch</last_name>
    <phone>01067593438</phone>
    <email>Safaathabet63@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Malames Faisal, Lecturer</last_name>
    <phone>01098958995</phone>
    <email>misofaisal@yahoo.co.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Faculty of medicine ainshams university</name>
      <address>
        <city>Cairo</city>
        <zip>11865</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Safaa Thabet</last_name>
      <phone>01157514436</phone>
      <email>remystar763@yahoo.com</email>
    </contact>
    <contact_backup>
      <last_name>Malames Faisal</last_name>
      <phone>01098958995</phone>
      <email>Misofaisal@yahoo.co.uk</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Lopes ES, Feitosa FEL, Brazil AV, de Castro JDV, da Costa JIF, Araujo Junior E, Peixoto AB, Carvalho FHC. Assessment of Sensitivity and Specificity of Ultrasound and Magnetic Resonance Imaging in the Diagnosis of Placenta Accreta. Rev Bras Ginecol Obstet. 2019 Jan;41(1):17-23. doi: 10.1055/s-0038-1675803. Epub 2018 Nov 14.</citation>
    <PMID>30428490</PMID>
  </reference>
  <reference>
    <citation>Haunschild C, Yeaton-Massey A, Lyell DJ. Antenatal Management of Placenta Accreta. Clin Obstet Gynecol. 2018 Dec;61(4):766-773. doi: 10.1097/GRF.0000000000000394.</citation>
    <PMID>30204620</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>November 17, 2018</study_first_submitted>
  <study_first_submitted_qc>January 20, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>July 16, 2020</last_update_submitted>
  <last_update_submitted_qc>July 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Safaa thabet abd El Aziz Ahmed</investigator_full_name>
    <investigator_title>Principal investigator</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>
  <!-- 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/NCT03813212
org study id: MRI placenta accreta
nct id: NCT03813212
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study aim to assess the accuracy of magnetic resonance imaging (MRI) compared to
      gray-scale and colour Doppler ultrasound (US) for the prenatal diagnosis of placenta accreta.
Placenta accreta occurs when the chorionic villi abnormally invade the myometrium. Based on
      histopathology it is divided into three grades: placenta accreta (the chorionic villi are in
      contact with the myometrium), placenta increta (the chorionic villi invade the myometrium),
      and placenta percreta where the chorionic villi penetrate the uterine serosa. With increasing
      rate of cesarean delivery, the incidence of both placenta praevia and placenta accreta is
      steadily increasing in frequency.

      Prenatal diagnosis of invasive placentation is associated with a reduced risk of maternal
      complications as it allows a preplanned treatment of the condition . Gray-scale and colour
      Doppler ultrasound (US) are valuable tools in the prenatal diagnosis of placenta accreta
      .However, if the ultrasound ( US ) findings suggest possible percreta or are inconclusive or
      negative in an at-risk woman, magnetic resonance imaging (MRI) can be useful.

      Multiple sonographic findings are seen with placenta accreta such as decrease in myometrial
      thickness, placenta previa, placental lacunae, abnormal pattern of color Doppler, loss of the
      retroplacental clear zone and placenta percreta irregularities in wall of urinary bladder (
      UB ) have been detected .

      The most magnetic resonance imaging characteristic findings seen in placenta accreta are
      nodular thickening in the dark zone of placenta-uterine interface together with extensions of
      dark bands through the placenta, outer uterine bulge causing from the mass effect of the
      placenta and heterogeneous signal intensity of placenta on the T2-weighted HASTE sequences
      due to large placental lakes and vessels.
observational model: Cohort
time perspective: Prospective
measure: Determination of degree of placental invasion
time frame: Baseline
description: Determination of degree of placental invasion by comparing the results obtained by ultrasound , MRI with the final pathological examination after operation ( the excised part of myometrium with the attached placenta or hysterectomy specimen ).
measure: Change Maternal morbidity and mortality
time frame: Baseline
intervention type: Device
intervention name: MRI
description: Magnetic resonance imaging. Trans-abdominal sonography (TAS) and transvaginal sonography (TVS) will be performed using a 3.5 or 5 MHz transabdominal convex transducer and a 7 MHz trans-vaginal transducer.
other name: Ultrasound
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: 20 Years
maximum age: 40 Years
last name: Safaa Thabet, M.B.B.,Ch
phone: 01067593438
email: Safaathabet63@yahoo.com
last name: Malames Faisal, Lecturer
phone: 01098958995
email: misofaisal@yahoo.co.uk
facility: 
status: Recruiting
contact: 
contact backup: 
country: Egypt
citation: Lopes ES, Feitosa FEL, Brazil AV, de Castro JDV, da Costa JIF, Araujo Junior E, Peixoto AB, Carvalho FHC. Assessment of Sensitivity and Specificity of Ultrasound and Magnetic Resonance Imaging in the Diagnosis of Placenta Accreta. Rev Bras Ginecol Obstet. 2019 Jan;41(1):17-23. doi: 10.1055/s-0038-1675803. Epub 2018 Nov 14.
PMID: 30428490
citation: Haunschild C, Yeaton-Massey A, Lyell DJ. Antenatal Management of Placenta Accreta. Clin Obstet Gynecol. 2018 Dec;61(4):766-773. doi: 10.1097/GRF.0000000000000394.
PMID: 30204620
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Safaa thabet abd El Aziz Ahmed
investigator title: Principal investigator
mesh term: Placenta Accreta