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/NCT06002256</url>
    </required_header>
    <id_info>
      <org_study_id>598</org_study_id>
      <nct_id>NCT06002256</nct_id>
    </id_info>
    <brief_title>Mostafa Maged Maneuver in Comparison With Bimanual Uterine Compression to Control Post-partum Hemorrhage</brief_title>
    <official_title>Mostafa Maged Maneuver in Comparison With Bimanual Uterine Compression to Control Post-partum Hemorrhage</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ministry of Health and Population, Egypt</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Al-Azhar University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Ministry of Health and Population, Egypt</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>
        The current study aimed to investigate the effectiveness of the Mostafa Maged maneuver&#xD;
        compared to Bimanual uterine compression in controlling postpartum hemorrhage during vaginal&#xD;
        delivery.&#xD;
  &#xD;
        The study subjects were categorized into two groups. The first group was managed by the&#xD;
        Mostafa Maged maneuver , whereas the second group was managed by routine bimanual uterine&#xD;
        compression.&#xD;
  &#xD;
        investigators attempted to determine the duration of each maneuver required until the&#xD;
        investigator became exhausted, as well as whether or not oxytocin was administered later in&#xD;
        each maneuver .&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">August 15, 2023</start_date>
    <completion_date type="Actual">September 1, 2023</completion_date>
    <primary_completion_date type="Actual">September 1, 2023</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Good hemostasis and achieving the uterus contracted</measure>
      <time_frame>first 3 hours</time_frame>
      <description>no post-partum hemorrhage , we assess this by the amount of bleeding going down and by the atonic status of the uterus at that time</description>
    </primary_outcome>
    <primary_outcome>
      <measure>obstetrician does not feel fatigued</measure>
      <time_frame>during applying the maneuver</time_frame>
      <description>no exhaustion for the obstetrician , and this outcome is told by the investigators themselves</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">50</enrollment>
    <condition>Post-partum Hemorrhage</condition>
    <arm_group>
      <arm_group_label>Group 1 : Mostafa Maged maneuver</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The first step in the Mostafa Maged maneuveur step is placing the right hand to the posterior fornix of vaginal canal trying to put pressure on the cervix and the lower part of uterus compressing the anterior and posterior walls of the lower uterine segment. The second point is placing the left hand over the fundus of the uterus and the posterior wall of the uterus from the abdominal part of the pregnant mother (the side of the abdominal skin). The third step is trying to grasp the whole uterus by the two hands abdominally and vaginally against the symphysis pubis as if the uterus is containing or surrounding the symphysis pubis bone, and in this way, getting the anterior and posterior walls of the uterus against each other (compression achieved)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2 : bimanual uterine compression</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Both maneuver s are performed immediately after the delivery of the placenta and foetus, with no uterotonics administered at the onset of these maneuver s. In the event of atony after hand release due to fatigue, 5 IU of oxytocin is administered intravenously as uterotonics.&#xD;
  the clinician places one hand on the abdomen and the other hand inside the vagina then compresses the uterus between the two hands.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Mostafa Maged maneuver</intervention_name>
      <description>While the patient is on the lithotomy position , The first step in the Mostafa Maged maneuveur step is placing the right hand to the posterior fornix of vaginal canal trying to put pressure on the cervix and the lower part of uterus compressing the anterior and posterior walls of the lower uterine segment. The second point is placing the left hand over the fundus of the uterus and the posterior wall of the uterus from the abdominal part of the pregnant mother (the side of the abdominal skin). The third step is trying to grasp the whole uterus by the two hands abdominally and vaginally against the symphysis pubis as if the uterus is containing or surrounding the symphysis pubis bone, and in this way, getting the anterior and posterior walls of the uterus against each other (compression achieved)</description>
      <arm_group_label>Group 1 : Mostafa Maged maneuver</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Bimanual uterine compression</intervention_name>
      <description>the clinician places one hand on the abdomen and the other hand inside the vagina then compresses the uterus between the two hands.</description>
      <arm_group_label>Group 2 : bimanual uterine compression</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          - female and pregnant&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  hematological diseases morbid obese smoking&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Female pregnant</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Fayoum general hospital and al azhar university</name>
        <address>
          <city>Cairo</city>
          <state>Cairo And Fayoum</state>
          <zip>0020</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ministry of Health and Population, Egypt</investigator_affiliation>
      <investigator_full_name>Mostafa Maged Ali</investigator_full_name>
      <investigator_title>principal investigator</investigator_title>
    </responsible_party>
    <keyword>Mostafa Maged maneuver</keyword>
    <keyword>Bimanual uterine compression</keyword>
    <keyword>vaginal delivery</keyword>
    <keyword>postpartum hemorrhage</keyword>
    <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>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/NCT06002256
  org study id: 598
  nct id: NCT06002256
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The current study aimed to investigate the effectiveness of the Mostafa Maged maneuver
        compared to Bimanual uterine compression in controlling postpartum hemorrhage during vaginal
        delivery.
  
        The study subjects were categorized into two groups. The first group was managed by the
        Mostafa Maged maneuver , whereas the second group was managed by routine bimanual uterine
        compression.
  
        investigators attempted to determine the duration of each maneuver required until the
        investigator became exhausted, as well as whether or not oxytocin was administered later in
        each maneuver .
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Good hemostasis and achieving the uterus contracted
  time frame: first 3 hours
  description: no post-partum hemorrhage , we assess this by the amount of bleeding going down and by the atonic status of the uterus at that time
  measure: obstetrician does not feel fatigued
  time frame: during applying the maneuver
  description: no exhaustion for the obstetrician , and this outcome is told by the investigators themselves
  arm group label: Group 1 : Mostafa Maged maneuver
  arm group type: Active Comparator
  description: The first step in the Mostafa Maged maneuveur step is placing the right hand to the posterior fornix of vaginal canal trying to put pressure on the cervix and the lower part of uterus compressing the anterior and posterior walls of the lower uterine segment. The second point is placing the left hand over the fundus of the uterus and the posterior wall of the uterus from the abdominal part of the pregnant mother (the side of the abdominal skin). The third step is trying to grasp the whole uterus by the two hands abdominally and vaginally against the symphysis pubis as if the uterus is containing or surrounding the symphysis pubis bone, and in this way, getting the anterior and posterior walls of the uterus against each other (compression achieved)
  arm group label: Group 2 : bimanual uterine compression
  arm group type: Other
  description: Both maneuver s are performed immediately after the delivery of the placenta and foetus, with no uterotonics administered at the onset of these maneuver s. In the event of atony after hand release due to fatigue, 5 IU of oxytocin is administered intravenously as uterotonics.
  the clinician places one hand on the abdomen and the other hand inside the vagina then compresses the uterus between the two hands.
  intervention type: Procedure
  intervention name: Mostafa Maged maneuver
  description: While the patient is on the lithotomy position , The first step in the Mostafa Maged maneuveur step is placing the right hand to the posterior fornix of vaginal canal trying to put pressure on the cervix and the lower part of uterus compressing the anterior and posterior walls of the lower uterine segment. The second point is placing the left hand over the fundus of the uterus and the posterior wall of the uterus from the abdominal part of the pregnant mother (the side of the abdominal skin). The third step is trying to grasp the whole uterus by the two hands abdominally and vaginally against the symphysis pubis as if the uterus is containing or surrounding the symphysis pubis bone, and in this way, getting the anterior and posterior walls of the uterus against each other (compression achieved)
  arm group label: Group 1 : Mostafa Maged maneuver
  intervention type: Procedure
  intervention name: Bimanual uterine compression
  description: the clinician places one hand on the abdomen and the other hand inside the vagina then compresses the uterus between the two hands.
  arm group label: Group 2 : bimanual uterine compression
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Female pregnant
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: No
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Ministry of Health and Population, Egypt
  investigator full name: Mostafa Maged Ali
  investigator title: principal investigator
  mesh term: Postpartum Hemorrhage
  mesh term: Hemorrhage
  sharing ipd: No