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/NCT06029985</url>
    </required_header>
    <id_info>
      <org_study_id>Hysteroscopic Follow-Up</org_study_id>
      <nct_id>NCT06029985</nct_id>
    </id_info>
    <brief_title>Hysteroscopic Follow-up Following Conservative Stepwise Surgical Approach for Management of Placenta Previa Accreta</brief_title>
    <official_title>Hysteroscopic Follow up Following Conservative Stepwise Surgical Approach for Management of Placenta Previa Accreta</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>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>
        Conservative management of placenta accreta spectrum can preserve future fertility but should&#xD;
        only be done in hospitals with enough experience as it carries a high risk of maternal&#xD;
        complications.&#xD;
  &#xD;
        Follow up after conservative management is crucial to detect complications early.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Placenta accreta is defined histopathologically as abnormal trophoblast invasion of part or&#xD;
        all of the placenta into the myometrium of the uterine wall.1 Depending on the depth of&#xD;
        villous tissue invasiveness, placenta accreta was subdivided by pathologists into &quot;creta&quot;,&#xD;
        &quot;increta&quot;, and &quot;percreta&quot;, in which the villi adhere superficially to the myometrium without&#xD;
        interposing decidua, penetrate deeply into the uterine myometrium, and perforate through the&#xD;
        entire uterine wall and may invade the surrounding pelvic organs, respectively.&#xD;
  &#xD;
        The term placenta accreta spectrum (PAS) will be used in this manuscript to include both the&#xD;
        abnormally adherent and the invasive forms of accreta placentation. Severe and sometimes&#xD;
        life-threatening hemorrhage, which often requires blood transfusion, increases maternal&#xD;
        morbidity and mortality.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 1, 2019</start_date>
    <completion_date type="Actual">December 31, 2020</completion_date>
    <primary_completion_date type="Actual">December 1, 2020</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Easiness of hysteroscopy introduction</measure>
      <time_frame>3-6 months</time_frame>
      <description>accessibility of hysteroscopic examination</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Adequacy of uterine cavity</measure>
      <time_frame>3-6 months</time_frame>
      <description>visualization of the uterus will be assessed using office hysteroscopy</description>
    </primary_outcome>
    <primary_outcome>
      <measure>intrauterine adhesions</measure>
      <time_frame>3-6 months</time_frame>
      <description>visualization of the intrauterine adhesions will be assessed using office hysteroscopy</description>
    </primary_outcome>
    <primary_outcome>
      <measure>cesarean scar niche</measure>
      <time_frame>3-6 months</time_frame>
      <description>presence of a pouch, that forms on the wall of your uterus.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Menstrual pattern</measure>
      <time_frame>3-6 months</time_frame>
      <description>menstrual irregularities by history regarding Regular and normal volume or Regular and scanty or presence of Intermenstrual bleeding</description>
    </primary_outcome>
    <enrollment type="Actual">50</enrollment>
    <condition>Placenta Accreta</condition>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Hysteroscopic Follow Up</intervention_name>
      <description>Office hysteroscopy was carried out to detect the scar site, performed with a 4-mm, continuous-flow operative hysteroscope by vaginoscopic approach, without analgesia or anesthesia. Distension of the uterus was obtained using a normal solution as distension medium, dispensed by an electronic suction/irrigation pump. This can maintain a constant intrauterine pressure of around 30-40 mmHg, balancing an irrigation flow of 200 mL/min with a vacuum of 0.2 bars, necessary to avoid overdistension of the muscle fibers and patient discomfort. The use of this distension medium allows blood or mucus to be washed out from the pouch if necessary.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Women with one or more previous cesarean deliveries who were diagnosed with placenta previa&#xD;
          accreta and underwent Conservative stepwise surgical approach for management in Ain shams&#xD;
          maternity hospital&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Pregnant women with one or more previous cesarean deliveries&#xD;
  &#xD;
            2. Women diagnosed with placenta previa accreta and underwent Conservative stepwise&#xD;
               surgical approach for management.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. women who refused to participate in the study.&#xD;
  &#xD;
            2. Associated other medical conditions as pregnancy-induced hypertension, heart diseases,&#xD;
               and rheumatological diseases apart from iron deficiency anemia.&#xD;
  &#xD;
            3. Presence of uterine anomalies&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Mohamed Samy, MD</last_name>
      <role>Study Director</role>
      <affiliation>Ain Shams Maternity Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Ain Shams University Maternity Hospital</name>
        <address>
          <city>Cairo</city>
          <zip>11865</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 26, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 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 8, 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 Mohamed Ghaleb</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <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>
    <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/NCT06029985
  org study id: Hysteroscopic Follow-Up
  nct id: NCT06029985
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Conservative management of placenta accreta spectrum can preserve future fertility but should
        only be done in hospitals with enough experience as it carries a high risk of maternal
        complications.
  
        Follow up after conservative management is crucial to detect complications early.
  Placenta accreta is defined histopathologically as abnormal trophoblast invasion of part or
        all of the placenta into the myometrium of the uterine wall.1 Depending on the depth of
        villous tissue invasiveness, placenta accreta was subdivided by pathologists into "creta",
        "increta", and "percreta", in which the villi adhere superficially to the myometrium without
        interposing decidua, penetrate deeply into the uterine myometrium, and perforate through the
        entire uterine wall and may invade the surrounding pelvic organs, respectively.
  
        The term placenta accreta spectrum (PAS) will be used in this manuscript to include both the
        abnormally adherent and the invasive forms of accreta placentation. Severe and sometimes
        life-threatening hemorrhage, which often requires blood transfusion, increases maternal
        morbidity and mortality.
  observational model: Case-Only
  time perspective: Prospective
  measure: Easiness of hysteroscopy introduction
  time frame: 3-6 months
  description: accessibility of hysteroscopic examination
  measure: Adequacy of uterine cavity
  time frame: 3-6 months
  description: visualization of the uterus will be assessed using office hysteroscopy
  measure: intrauterine adhesions
  time frame: 3-6 months
  description: visualization of the intrauterine adhesions will be assessed using office hysteroscopy
  measure: cesarean scar niche
  time frame: 3-6 months
  description: presence of a pouch, that forms on the wall of your uterus.
  measure: Menstrual pattern
  time frame: 3-6 months
  description: menstrual irregularities by history regarding Regular and normal volume or Regular and scanty or presence of Intermenstrual bleeding
  intervention type: Diagnostic Test
  intervention name: Hysteroscopic Follow Up
  description: Office hysteroscopy was carried out to detect the scar site, performed with a 4-mm, continuous-flow operative hysteroscope by vaginoscopic approach, without analgesia or anesthesia. Distension of the uterus was obtained using a normal solution as distension medium, dispensed by an electronic suction/irrigation pump. This can maintain a constant intrauterine pressure of around 30-40 mmHg, balancing an irrigation flow of 200 mL/min with a vacuum of 0.2 bars, necessary to avoid overdistension of the muscle fibers and patient discomfort. The use of this distension medium allows blood or mucus to be washed out from the pouch if necessary.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 45 Years
  last name: Mohamed Samy, MD
  role: Study Director
  affiliation: Ain Shams Maternity Hospital
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Ain Shams Maternity Hospital
  investigator full name: Mahmoud Mohamed Ghaleb
  investigator title: Professor
  mesh term: Placenta Accreta
  mesh term: Placenta Previa
  sharing ipd: No