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/NCT05996926</url>
    </required_header>
    <id_info>
      <org_study_id>FMASU MD25/2021</org_study_id>
      <nct_id>NCT05996926</nct_id>
    </id_info>
    <brief_title>Diagnostic Accuracy of Saline Sonohystrography vs. 3D Transvaginal Ultrasound for Cesarean Scar Defect Assessment</brief_title>
    <official_title>Diagnostic Correlation Between Saline Infused Sonohystrography and Three Dimensional Transvaginal Ultrasound in the Assessment of Cesarean Section Scar Defect. A Study of a Diagnostic Test Accuracy</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>No</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>
        To compare accuracy of three dimensional transvaginal ultrasound versus the &quot;gold standard&quot;&#xD;
        saline infused sonography for assessing the characteristics, frequency and appearance of&#xD;
        caesarean scar defects in symptomatic patients with a history of cesarean section.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Cesarean section (CS) is a frequently performed surgical procedure in obstetric practice.&#xD;
        With a significant number of women undergoing this procedure annually, studying its impact on&#xD;
        future reproductive capacity has become increasingly important.&#xD;
  &#xD;
        The prevalence of cesarean deliveries is rising and constitutes about one-third of all births&#xD;
        in both the USA and Italy. As the use of cesarean delivery increases, so do the associated&#xD;
        complications, including cesarean scar pregnancy, morbidly adherent placenta, and Cesarean&#xD;
        section scar dehiscence and rupture.&#xD;
  &#xD;
        Cesarean scar defects (CSD) are described using various terms (pouch, niche, or isthmocoele)&#xD;
        and are characterized by thinning of the myometrium or a uterine scar dehiscence, often&#xD;
        appearing as a triangular shape within the endometrial cavity.&#xD;
  &#xD;
        The exact prevalence of symptomatic Cesarean scar defects varies due to factors like&#xD;
        population differences and lack of standardized criteria. Clinical presentations of Cesarean&#xD;
        scar defects range from no symptoms to abnormal uterine bleeding, infertility, dyspareunia,&#xD;
        and pelvic pain.&#xD;
  &#xD;
        Women with a history of Cesarean section are considered high-risk during pregnancy and&#xD;
        require specialized assessments to ensure scar integrity. Saline-infused sonography&#xD;
        (Sonohystrography) is effective for demonstrating caesarean niches, although transvaginal&#xD;
        ultrasound (TVS) is more accessible and commonly used.&#xD;
  &#xD;
        Experts generally agree that a niche should be defined by an indentation at the CS scar site&#xD;
        with a depth of at least 2 mm, and it can be classified as simple, simple with one branch, or&#xD;
        complex with multiple branches. Additional measurements, such as the distances between the&#xD;
        niche and the vesicovaginal fold, are useful for surgical planning.&#xD;
  &#xD;
        Given the increasing frequency of cesarean deliveries, healthcare providers will encounter&#xD;
        related complications more frequently. Cesarean scar defects are common yet often go&#xD;
        undiagnosed. Encouraging vaginal birth after cesarean (VBAC) can help reduce cesarean rates&#xD;
        and raise questions about future obstetric practices, especially in developing countries.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 30, 2023</start_date>
    <completion_date type="Anticipated">August 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Diagnostic Accuracy of Cesarean Scar Defect Assessment Using 3D TVS</measure>
      <time_frame>Intraoperatively</time_frame>
      <description>This outcome measure aims to evaluate the diagnostic accuracy of three-dimensional transvaginal ultrasound (3D TVS) as measurement tools in assessing Cesarean Scar Defects (CSD) and associated complications among symptomatic patients with a history of cesarean section. The assessment will involve identifying, classifying, and measuring Cesarean Scar Defects (CSD) characteristics using these specific measurement techniques.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Diagnostic Accuracy of Cesarean Scar Defect Assessment Using Saline-Infused Sonography</measure>
      <time_frame>Intraoperatively</time_frame>
      <description>This outcome measure aims to evaluate the diagnostic accuracy of saline-infused sonography (Sonohystrography) as measurement tools in assessing Cesarean Scar Defects (CSD) and associated complications among symptomatic patients with a history of cesarean section. The assessment will involve identifying, classifying, and measuring Cesarean Scar Defects (CSD) characteristics using these specific measurement techniques.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">72</enrollment>
    <condition>Cesarean Scar Defects</condition>
    <condition>Cesarean Section Complications</condition>
    <condition>Uterine Scar Dehiscence</condition>
    <condition>Vaginal Birth After Cesarean</condition>
    <condition>Abnormal Uterine Bleeding</condition>
    <arm_group>
      <arm_group_label>Three-Dimensional Transvaginal Ultrasound (3D TVS)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In this study, Three-Dimensional Transvaginal Ultrasound will be employed as one of the interventions to evaluate Cesarean Scar Defects (CSD) and associated complications in symptomatic patients with a history of cesarean section.&#xD;
  A specialized ultrasound machine (Samsung WS80A) equipped with a transvaginal 2-11 MHz probe will be used for the Three-Dimensional Transvaginal Ultrasound examination. The examination will be conducted in the 1st half of the menstrual cycle. The ultrasound probe will be introduced into the posterior fornix of the vagina to capture three-dimensional images of the uterus and scar area. The examiner will identify and measure the characteristics of the Cesarean Scar Defects (CSD), including length, depth, width, volume, residual myometrial thickness, adjacent myometrial thickness, and presence of any branches.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Saline-Infused Sonography (Sonohystrography)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The Sonohystrography will be performed using a Toshiba ECCO CEE SSA-340A ultrasound equipment with a 7.5 MHz transvaginal probe. A sterile vaginal speculum will be inserted, the cervix cleansed with an antiseptic solution, and a thin Foley's catheter inserted into the cervical os. Sterile saline solution will be infused into the uterus through the catheter to distend the uterine cavity. The examiner will use the ultrasound probe to visualize and assess the uterine cavity, focusing on identifying and measuring Cesarean Scar Defects (CSD) characteristics, including depth, width, volume, and myometrial thickness.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Three-Dimensional Transvaginal Ultrasound (3D TVS)</intervention_name>
      <description>In this study, Three-Dimensional Transvaginal Ultrasound will be employed as one of the interventions to evaluate Cesarean Scar Defects (CSD) and associated complications in symptomatic patients with a history of cesarean section.&#xD;
  Procedure: A specialized ultrasound machine (Samsung WS80A) equipped with a transvaginal 2-11 MHz probe will be used for the Three-Dimensional Transvaginal Ultrasound examination. The examination will be conducted in the 1st half of the menstrual cycle. The ultrasound probe will be introduced into the posterior fornix of the vagina to capture three-dimensional images of the uterus and scar area. The examiner will identify and measure the characteristics of the Cesarean Scar Defects (CSD), including length, depth, width, volume, residual myometrial thickness, adjacent myometrial thickness, and presence of any branches.</description>
      <arm_group_label>Three-Dimensional Transvaginal Ultrasound (3D TVS)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Saline-Infused Sonography (Sonohystrography)</intervention_name>
      <description>The Sonohystrography will be performed using a Toshiba ECCO CEE SSA-340A ultrasound equipment with a 7.5 MHz transvaginal probe. A sterile vaginal speculum will be inserted, the cervix cleansed with an antiseptic solution, and a thin Foley's catheter inserted into the cervical os. Sterile saline solution will be infused into the uterus through the catheter to distend the uterine cavity. The examiner will use the ultrasound probe to visualize and assess the uterine cavity, focusing on identifying and measuring Cesarean Scar Defects (CSD) characteristics, including depth, width, volume, and myometrial thickness.</description>
      <arm_group_label>Saline-Infused Sonography (Sonohystrography)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age between 20 and 45 years&#xD;
  &#xD;
            -  Previous 1-3 cesarean sections&#xD;
  &#xD;
            -  The duration from the last cesarean section ranging from 6 months to 5 years.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnancy (Positive pregnancy test)&#xD;
  &#xD;
            -  Recent pelvic infection.&#xD;
  &#xD;
            -  Active pelvic infection.&#xD;
  &#xD;
            -  Recent surgery on the tubes or the uterus.&#xD;
  &#xD;
            -  Active vaginal bleeding.&#xD;
  &#xD;
            -  Menstruation.&#xD;
  &#xD;
            -  Suspected malignancy.&#xD;
  &#xD;
            -  Intrauterine device in situ.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Women aged between 20 and 45 years with a history of 1 to 3 previous cesarean sections (CS) and a duration of time since the last CS ranging from 6 months to 5 years will be eligible for enrollment in this study.</gender_description>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Israa Sherif, MBBCH</last_name>
      <phone>01020277037</phone>
      <phone_ext>+2</phone_ext>
      <email>israa.bahaa@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Ain Shams University</name>
        <address>
          <city>Cairo</city>
          <country>Egypt</country>
        </address>
      </facility>
      <contact>
        <last_name>Israa Sherif, M.B.B.CH</last_name>
        <phone>01020277037</phone>
        <phone_ext>+2</phone_ext>
        <email>israa.bahaa@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Israa Bahaa Hassan Sherif</investigator_full_name>
      <investigator_title>Resident of Obstetrics and Gynecology, Nile specialized Hospital, Egypt</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Uterine Hemorrhage</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The study protocol will be available upon a reasonable request.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>One you after the end of the study</ipd_time_frame>
    </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/NCT05996926
  org study id: FMASU MD25/2021
  nct id: NCT05996926
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  To compare accuracy of three dimensional transvaginal ultrasound versus the "gold standard"
        saline infused sonography for assessing the characteristics, frequency and appearance of
        caesarean scar defects in symptomatic patients with a history of cesarean section.
  Cesarean section (CS) is a frequently performed surgical procedure in obstetric practice.
        With a significant number of women undergoing this procedure annually, studying its impact on
        future reproductive capacity has become increasingly important.
  
        The prevalence of cesarean deliveries is rising and constitutes about one-third of all births
        in both the USA and Italy. As the use of cesarean delivery increases, so do the associated
        complications, including cesarean scar pregnancy, morbidly adherent placenta, and Cesarean
        section scar dehiscence and rupture.
  
        Cesarean scar defects (CSD) are described using various terms (pouch, niche, or isthmocoele)
        and are characterized by thinning of the myometrium or a uterine scar dehiscence, often
        appearing as a triangular shape within the endometrial cavity.
  
        The exact prevalence of symptomatic Cesarean scar defects varies due to factors like
        population differences and lack of standardized criteria. Clinical presentations of Cesarean
        scar defects range from no symptoms to abnormal uterine bleeding, infertility, dyspareunia,
        and pelvic pain.
  
        Women with a history of Cesarean section are considered high-risk during pregnancy and
        require specialized assessments to ensure scar integrity. Saline-infused sonography
        (Sonohystrography) is effective for demonstrating caesarean niches, although transvaginal
        ultrasound (TVS) is more accessible and commonly used.
  
        Experts generally agree that a niche should be defined by an indentation at the CS scar site
        with a depth of at least 2 mm, and it can be classified as simple, simple with one branch, or
        complex with multiple branches. Additional measurements, such as the distances between the
        niche and the vesicovaginal fold, are useful for surgical planning.
  
        Given the increasing frequency of cesarean deliveries, healthcare providers will encounter
        related complications more frequently. Cesarean scar defects are common yet often go
        undiagnosed. Encouraging vaginal birth after cesarean (VBAC) can help reduce cesarean rates
        and raise questions about future obstetric practices, especially in developing countries.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Diagnostic
  masking: Double (Participant, Investigator)
  measure: Diagnostic Accuracy of Cesarean Scar Defect Assessment Using 3D TVS
  time frame: Intraoperatively
  description: This outcome measure aims to evaluate the diagnostic accuracy of three-dimensional transvaginal ultrasound (3D TVS) as measurement tools in assessing Cesarean Scar Defects (CSD) and associated complications among symptomatic patients with a history of cesarean section. The assessment will involve identifying, classifying, and measuring Cesarean Scar Defects (CSD) characteristics using these specific measurement techniques.
  measure: Diagnostic Accuracy of Cesarean Scar Defect Assessment Using Saline-Infused Sonography
  time frame: Intraoperatively
  description: This outcome measure aims to evaluate the diagnostic accuracy of saline-infused sonography (Sonohystrography) as measurement tools in assessing Cesarean Scar Defects (CSD) and associated complications among symptomatic patients with a history of cesarean section. The assessment will involve identifying, classifying, and measuring Cesarean Scar Defects (CSD) characteristics using these specific measurement techniques.
  arm group label: Three-Dimensional Transvaginal Ultrasound (3D TVS)
  arm group type: Experimental
  description: In this study, Three-Dimensional Transvaginal Ultrasound will be employed as one of the interventions to evaluate Cesarean Scar Defects (CSD) and associated complications in symptomatic patients with a history of cesarean section.
  A specialized ultrasound machine (Samsung WS80A) equipped with a transvaginal 2-11 MHz probe will be used for the Three-Dimensional Transvaginal Ultrasound examination. The examination will be conducted in the 1st half of the menstrual cycle. The ultrasound probe will be introduced into the posterior fornix of the vagina to capture three-dimensional images of the uterus and scar area. The examiner will identify and measure the characteristics of the Cesarean Scar Defects (CSD), including length, depth, width, volume, residual myometrial thickness, adjacent myometrial thickness, and presence of any branches.
  arm group label: Saline-Infused Sonography (Sonohystrography)
  arm group type: Experimental
  description: The Sonohystrography will be performed using a Toshiba ECCO CEE SSA-340A ultrasound equipment with a 7.5 MHz transvaginal probe. A sterile vaginal speculum will be inserted, the cervix cleansed with an antiseptic solution, and a thin Foley's catheter inserted into the cervical os. Sterile saline solution will be infused into the uterus through the catheter to distend the uterine cavity. The examiner will use the ultrasound probe to visualize and assess the uterine cavity, focusing on identifying and measuring Cesarean Scar Defects (CSD) characteristics, including depth, width, volume, and myometrial thickness.
  intervention type: Diagnostic Test
  intervention name: Three-Dimensional Transvaginal Ultrasound (3D TVS)
  description: In this study, Three-Dimensional Transvaginal Ultrasound will be employed as one of the interventions to evaluate Cesarean Scar Defects (CSD) and associated complications in symptomatic patients with a history of cesarean section.
  Procedure: A specialized ultrasound machine (Samsung WS80A) equipped with a transvaginal 2-11 MHz probe will be used for the Three-Dimensional Transvaginal Ultrasound examination. The examination will be conducted in the 1st half of the menstrual cycle. The ultrasound probe will be introduced into the posterior fornix of the vagina to capture three-dimensional images of the uterus and scar area. The examiner will identify and measure the characteristics of the Cesarean Scar Defects (CSD), including length, depth, width, volume, residual myometrial thickness, adjacent myometrial thickness, and presence of any branches.
  arm group label: Three-Dimensional Transvaginal Ultrasound (3D TVS)
  intervention type: Diagnostic Test
  intervention name: Saline-Infused Sonography (Sonohystrography)
  description: The Sonohystrography will be performed using a Toshiba ECCO CEE SSA-340A ultrasound equipment with a 7.5 MHz transvaginal probe. A sterile vaginal speculum will be inserted, the cervix cleansed with an antiseptic solution, and a thin Foley's catheter inserted into the cervical os. Sterile saline solution will be infused into the uterus through the catheter to distend the uterine cavity. The examiner will use the ultrasound probe to visualize and assess the uterine cavity, focusing on identifying and measuring Cesarean Scar Defects (CSD) characteristics, including depth, width, volume, and myometrial thickness.
  arm group label: Saline-Infused Sonography (Sonohystrography)
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Women aged between 20 and 45 years with a history of 1 to 3 previous cesarean sections (CS) and a duration of time since the last CS ranging from 6 months to 5 years will be eligible for enrollment in this study.
  minimum age: 20 Years
  maximum age: 45 Years
  healthy volunteers: No
  last name: Israa Sherif, MBBCH
  phone: 01020277037
  phone ext: +2
  email: israa.bahaa@gmail.com
  facility: 
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Israa Bahaa Hassan Sherif
  investigator title: Resident of Obstetrics and Gynecology, Nile specialized Hospital, Egypt
  mesh term: Uterine Hemorrhage
  sharing ipd: Yes
  ipd description: The study protocol will be available upon a reasonable request.
  ipd info type: Study Protocol
  ipd time frame: One you after the end of the study