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/NCT06023381</url>
    </required_header>
    <id_info>
      <org_study_id>Sliding Sign</org_study_id>
      <nct_id>NCT06023381</nct_id>
    </id_info>
    <brief_title>Sliding Sign in Late Trimester Ultrasound Evaluation of Intra-abdominal Adhesions in Women Undergoing Repeat CS</brief_title>
    <official_title>Sliding Sign in Third-trimester Ultrasound Evaluation of Intra-abdominal Adhesions in Women Undergoing Repeat Cesarean Section</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ain Shams Maternity Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ain Shams Maternity Hospital</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>
        Predicting the presence of severe adhesions may also assist clinically in several ways:&#xD;
        first, it allows allocation of more complicated surgeries to experienced surgeons; second,&#xD;
        the surgeons can plan and prepare better for the surgery if they know in advance whether they&#xD;
        are going to operate a complicated surgery; third, a difficult surgery may be scheduled to be&#xD;
        performed in an experienced center, preparing cross match blood units, and alerting the&#xD;
        general surgeon and urologist of the potential risk for surgical complications, saving time&#xD;
        if intervention is required.&#xD;
  &#xD;
        This information can permit preoperative planning by a multidisciplinary team of surgeons and&#xD;
        allow the patient to be informed of the potentially high risk of complications.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The incidence of repeat cesarean delivery is on the rise worldwide, approximately 90% of&#xD;
        women with a prior cesarean delivery undergo a planned repeat cesarean delivery in their next&#xD;
        pregnancy.&#xD;
  &#xD;
        Post-cesarean adhesions are a major complication in subsequent surgeries, causing an&#xD;
        increased risk for bladder and bowel injury (0.1-0.3%), hemorrhage (0.1-1.4%), infection&#xD;
        (0.4-1.6%), and even hysterectomy (0.1-1.4%).&#xD;
  &#xD;
        In addition to the risk associated with the pelviabdominal surgical procedure itself,&#xD;
        adhesiolysis may result in injury to adjacent viscera, blood loss, and in case of emergency&#xD;
        cesarean delivery, to the perinatal adverse outcome associated with delayed delivery of the&#xD;
        neonate. This represents a considerable healthcare issue, as it has a significant impact both&#xD;
        on the patient, increasing morbidity and mortality, and on healthcare costs. It is therefore&#xD;
        important for surgeons to detect patients at high risk of having adhesions.&#xD;
  &#xD;
        Women suspected to have severe intra-abdominal adhesions may benefit from appropriate&#xD;
        preparation of blood products, better assignment of surgeons, request for preoperative&#xD;
        surgical assistance of other medical specialties, and possibly performance of a midline skin&#xD;
        incision to enter the peritoneal cavity. It is therefore important for surgeons to detect&#xD;
        patients at high risk of having adhesions.&#xD;
  &#xD;
        Various means have been proposed to predict adhesions prior to surgery, including analysis of&#xD;
        patient characteristics and appearance of the scar, as well as the intraoperative peritoneal&#xD;
        adhesion index.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">October 1, 2022</start_date>
    <completion_date type="Actual">July 1, 2023</completion_date>
    <primary_completion_date type="Actual">June 1, 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>The association between a negative sliding sign and severe adhesions</measure>
      <time_frame>24 hours</time_frame>
      <description>through transabdominal ultrasound</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The association between a negative sliding sign and operative time</measure>
      <time_frame>24 hours</time_frame>
      <description>time from skin incision to delivery of the baby</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>hemoglobin drop greater than 3 g/dL</measure>
      <time_frame>24 hours</time_frame>
      <description>calculated between preoperative and postoperative hemoglobin levels</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Urinary Bladder injury</measure>
      <time_frame>24 hours</time_frame>
      <description>intraoperative diagnosis or postoperatively</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intestinal injury</measure>
      <time_frame>24 hours</time_frame>
      <description>intraoperative diagnosis or postoperatively</description>
    </secondary_outcome>
    <enrollment type="Actual">200</enrollment>
    <condition>Cesarean Section Complications</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Sliding sign</intervention_name>
      <description>All women had Transabdominal Ultra-sonography using SAMSUNG WS80 &quot;elite&quot; ultrasound machine during the preoperative examination, using the real-time Transabdominal pelvic features (the relative motion between the maternal abdominal and uterine wall).&#xD;
  The patient was asked to breathe deeply, accentuating her respiratory movements and the sonographer recorded a video clip in a mid-sagittal plane lateral to umbilicus focus on the infra-umbilical space, to determine whether the structure glided freely in relation to adjacent structures. To be considered as sliding, the structures had to glide easily, one against the other (positive sliding sign); no motion of the structure in question signaled a negative sliding sign.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          All third trimester pregnant women with a history of previous cesarean section who were&#xD;
          admitted for elective caesarian section had Transabdominal Ultra-sound during the&#xD;
          preoperative examination, using the real-time Transabdominal ultrasound pelvic features&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. History of previous cesarean section.&#xD;
  &#xD;
            2. Gestational age: Full-Term.&#xD;
  &#xD;
            3. Scheduled to undergo elective cesarean section.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Body mass index more than 40 on admission.&#xD;
  &#xD;
            2. Abnormal placental invasion.&#xD;
  &#xD;
            3. Having known collagen disease.&#xD;
  &#xD;
            4. Unplanned or emergency repeated cesarean delivery.&#xD;
  &#xD;
            5. History of abdominal surgery.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Rania Gamal, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Ain Shams Maternity Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Faculty of Medicine, Ain shams University</name>
        <address>
          <city>Cairo</city>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ain Shams Maternity Hospital</investigator_affiliation>
      <investigator_full_name>Mahmoud Al Shirbiny Hamed Esmail</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>Tissue Adhesions</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT06023381
  org study id: Sliding Sign
  nct id: NCT06023381
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Predicting the presence of severe adhesions may also assist clinically in several ways:
        first, it allows allocation of more complicated surgeries to experienced surgeons; second,
        the surgeons can plan and prepare better for the surgery if they know in advance whether they
        are going to operate a complicated surgery; third, a difficult surgery may be scheduled to be
        performed in an experienced center, preparing cross match blood units, and alerting the
        general surgeon and urologist of the potential risk for surgical complications, saving time
        if intervention is required.
  
        This information can permit preoperative planning by a multidisciplinary team of surgeons and
        allow the patient to be informed of the potentially high risk of complications.
  The incidence of repeat cesarean delivery is on the rise worldwide, approximately 90% of
        women with a prior cesarean delivery undergo a planned repeat cesarean delivery in their next
        pregnancy.
  
        Post-cesarean adhesions are a major complication in subsequent surgeries, causing an
        increased risk for bladder and bowel injury (0.1-0.3%), hemorrhage (0.1-1.4%), infection
        (0.4-1.6%), and even hysterectomy (0.1-1.4%).
  
        In addition to the risk associated with the pelviabdominal surgical procedure itself,
        adhesiolysis may result in injury to adjacent viscera, blood loss, and in case of emergency
        cesarean delivery, to the perinatal adverse outcome associated with delayed delivery of the
        neonate. This represents a considerable healthcare issue, as it has a significant impact both
        on the patient, increasing morbidity and mortality, and on healthcare costs. It is therefore
        important for surgeons to detect patients at high risk of having adhesions.
  
        Women suspected to have severe intra-abdominal adhesions may benefit from appropriate
        preparation of blood products, better assignment of surgeons, request for preoperative
        surgical assistance of other medical specialties, and possibly performance of a midline skin
        incision to enter the peritoneal cavity. It is therefore important for surgeons to detect
        patients at high risk of having adhesions.
  
        Various means have been proposed to predict adhesions prior to surgery, including analysis of
        patient characteristics and appearance of the scar, as well as the intraoperative peritoneal
        adhesion index.
  observational model: Cohort
  time perspective: Prospective
  measure: The association between a negative sliding sign and severe adhesions
  time frame: 24 hours
  description: through transabdominal ultrasound
  measure: The association between a negative sliding sign and operative time
  time frame: 24 hours
  description: time from skin incision to delivery of the baby
  measure: hemoglobin drop greater than 3 g/dL
  time frame: 24 hours
  description: calculated between preoperative and postoperative hemoglobin levels
  measure: Urinary Bladder injury
  time frame: 24 hours
  description: intraoperative diagnosis or postoperatively
  measure: Intestinal injury
  time frame: 24 hours
  description: intraoperative diagnosis or postoperatively
  intervention type: Other
  intervention name: Sliding sign
  description: All women had Transabdominal Ultra-sonography using SAMSUNG WS80 "elite" ultrasound machine during the preoperative examination, using the real-time Transabdominal pelvic features (the relative motion between the maternal abdominal and uterine wall).
  The patient was asked to breathe deeply, accentuating her respiratory movements and the sonographer recorded a video clip in a mid-sagittal plane lateral to umbilicus focus on the infra-umbilical space, to determine whether the structure glided freely in relation to adjacent structures. To be considered as sliding, the structures had to glide easily, one against the other (positive sliding sign); no motion of the structure in question signaled a negative sliding sign.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Rania Gamal, MD
  role: Principal Investigator
  affiliation: Ain Shams Maternity Hospital
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Ain Shams Maternity Hospital
  investigator full name: Mahmoud Al Shirbiny Hamed Esmail
  investigator title: Principal Investigator
  mesh term: Tissue Adhesions
  sharing ipd: No