<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/NCT03772184</url>
  </required_header>
  <id_info>
    <org_study_id>Modified cervical inversion</org_study_id>
    <nct_id>NCT03772184</nct_id>
  </id_info>
  <brief_title>Modified Cervical Inversion During CS in Placenta Previa</brief_title>
  <official_title>Alalfy Modofied Cervical Inversion During CS in Placenta Previa</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aljazeera Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Suez Canal University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Aljazeera 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>
      There is an increasing rates of placenta previa nowadays&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      several techniques were described to control bleeding .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2019</start_date>
  <completion_date type="Actual">May 15, 2019</completion_date>
  <primary_completion_date type="Actual">May 12, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Using cervical inversion during cesarean section</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The number of women whose placental bed bleeding will be controlled by cervical inversion cervical inversion</measure>
    <time_frame>within an hour</time_frame>
    <description>how can the cervical inversion technique controls the placental bed bleeding</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">240</enrollment>
  <condition>Placenta Previa</condition>
  <arm_group>
    <arm_group_label>cervical inversion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>no cervical inversion</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cervical inversion</intervention_name>
    <description>inverting the cervical lip after delivery</description>
    <arm_group_label>cervical inversion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pregnant women 38 weeks or more with placenta previa&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant ladies with normally implanted placenta or placenta accreat , increta or&#xD;
             percreta&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>pregnant women with placenta previa</gender_description>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mahmoud Alalfy, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National research centre , Aljazeerah hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Algazeerah and helwan university</name>
      <address>
        <city>Giza</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>February 20, 2022</last_update_submitted>
  <last_update_submitted_qc>February 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aljazeera Hospital</investigator_affiliation>
    <investigator_full_name>Mahmoud Alalfy</investigator_full_name>
    <investigator_title>Lecturer Obstetrics and Gyneology , National Research Centre</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Placenta Previa</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/NCT03772184
org study id: Modified cervical inversion
nct id: NCT03772184
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
There is an increasing rates of placenta previa nowadays
several techniques were described to control bleeding .
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Using cervical inversion during cesarean section
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The number of women whose placental bed bleeding will be controlled by cervical inversion cervical inversion
time frame: within an hour
description: how can the cervical inversion technique controls the placental bed bleeding
arm group label: cervical inversion
arm group type: Active Comparator
arm group label: no cervical inversion
arm group type: No Intervention
intervention type: Procedure
intervention name: Cervical inversion
description: inverting the cervical lip after delivery
arm group label: cervical inversion
criteria: 
gender: Female
gender based: Yes
gender description: pregnant women with placenta previa
minimum age: 22 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mahmoud Alalfy, PhD
role: Principal Investigator
affiliation: National research centre , Aljazeerah hospital
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Aljazeera Hospital
investigator full name: Mahmoud Alalfy
investigator title: Lecturer Obstetrics and Gyneology , National Research Centre
mesh term: Placenta Previa