<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/NCT03241849</url>
  </required_header>
  <id_info>
    <org_study_id>STPPGE</org_study_id>
    <nct_id>NCT03241849</nct_id>
  </id_info>
  <brief_title>Surgical Technique To Control Postpartum Hemorrhage</brief_title>
  <official_title>New Surgical Technique To Control Postpartum Hemorrhage Due To Placenta Accreta</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut 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>
      Placenta accreta is an obstetrical complication where the placenta becomes firmly adherent to&#xD;
      the uterine wall. Placenta accreta can lead to considerable maternal morbidity and mortality&#xD;
      due to hemorrhage, infection, or other surgical complications such as those resulting from&#xD;
      hysterectomy. Retained placenta accreta is usually a rare condition, but its prevalence is&#xD;
      increasing due to the rise in the rate of deliveries by Cesarean section.&#xD;
&#xD;
      Placenta accreta is a potentially life-threatening obstetric condition that requires a&#xD;
      multidisciplinary approach to management. The incidence of placenta accreta has increased and&#xD;
      seems to parallel the increasing cesarean delivery rate. Women at greatest risk of placenta&#xD;
      accreta are those who have myometrial damage caused by a previous cesarean delivery with&#xD;
      either an anterior or posterior placenta previa overlying the uterine scar. Diagnosis of&#xD;
      placenta accreta before delivery allows multidisciplinary planning in an attempt to minimize&#xD;
      potential maternal or neonatal morbidity and mortality.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">February 1, 2020</completion_date>
  <primary_completion_date type="Actual">January 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Amount of blood loss (mL)</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Post Partum Hemorrhage</condition>
  <arm_group>
    <arm_group_label>Modified surgical technique for placenta accreta</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Modified surgical technique for placenta accreta</intervention_name>
    <description>suturing of the myometrium splitted by the placenta in cases presented by placenta accreta</description>
    <arm_group_label>Modified surgical technique for placenta accreta</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Estimated gestational age between 34 -40 weeks .&#xD;
&#xD;
          2. Presence of total or focal parts of placenta accreta &quot;morbidly adherent placenta&quot; .&#xD;
&#xD;
          3. Cases with mild vaginal bleeding or not having any vaginal bleeding&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Severe attack of bleeding require an immediate intervention.&#xD;
&#xD;
          2. Associated with placental abruption&#xD;
&#xD;
          3. Patients with known bleeding disorders or on anticoagulant therapy.&#xD;
&#xD;
          4. Preoperative decision to do peripartum hysterectomy.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Women Health Hospital - Assiut university</name>
      <address>
        <city>Assiut</city>
        <zip>71111</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>June 20, 2020</last_update_submitted>
  <last_update_submitted_qc>June 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mohammed Khairy Ali</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postpartum Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03241849
org study id: STPPGE
nct id: NCT03241849
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Placenta accreta is an obstetrical complication where the placenta becomes firmly adherent to
      the uterine wall. Placenta accreta can lead to considerable maternal morbidity and mortality
      due to hemorrhage, infection, or other surgical complications such as those resulting from
      hysterectomy. Retained placenta accreta is usually a rare condition, but its prevalence is
      increasing due to the rise in the rate of deliveries by Cesarean section.

      Placenta accreta is a potentially life-threatening obstetric condition that requires a
      multidisciplinary approach to management. The incidence of placenta accreta has increased and
      seems to parallel the increasing cesarean delivery rate. Women at greatest risk of placenta
      accreta are those who have myometrial damage caused by a previous cesarean delivery with
      either an anterior or posterior placenta previa overlying the uterine scar. Diagnosis of
      placenta accreta before delivery allows multidisciplinary planning in an attempt to minimize
      potential maternal or neonatal morbidity and mortality.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Amount of blood loss (mL)
time frame: 24 hours
arm group label: Modified surgical technique for placenta accreta
arm group type: Other
intervention type: Procedure
intervention name: Modified surgical technique for placenta accreta
description: suturing of the myometrium splitted by the placenta in cases presented by placenta accreta
arm group label: Modified surgical technique for placenta accreta
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mohammed Khairy Ali
investigator title: Dr
mesh term: Postpartum Hemorrhage
mesh term: Hemorrhage
sharing ipd: Undecided