<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/NCT04401839</url>
  </required_header>
  <id_info>
    <org_study_id>59</org_study_id>
    <nct_id>NCT04401839</nct_id>
  </id_info>
  <brief_title>Amr Maneuver for Prevention of Postpartum Hemorrhage</brief_title>
  <official_title>Amr Maneuver for Prevention of Postpartum Hemorrhage After Vaginal Delivery in Term Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</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>
      The patients were divided randomly in to 2 GROUPS:&#xD;
&#xD;
        -  control group: 153 patients received Oxytocin 10 IU I.V shot administered at the time of&#xD;
           delivery of the anterior shoulder of the baby according to the WHO recommendation for&#xD;
           both groups in prevention of postpartum haemorrhage,followed by active management of the&#xD;
           third stage of labor by administration of oxytocin 5 IU units IM (WHO GDG&#xD;
           recommendations,2012) and waiting for signs of placental separation then controlled cord&#xD;
           traction (CCT)to the umbilical cord while applying simultaneous counter-pressure to the&#xD;
           uterus, through the abdomen(Brandt Andrews maneuver)&#xD;
&#xD;
        -  study group:156 patients received Oxytocin 10 IU I.V shot at the time of delivery of the&#xD;
           of the anterior shoulder of the baby according to the WHO recommendation .Then oxytocin&#xD;
           is stopped and cervical traction (Amr maneuver )is applied.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patients were divided randomly in to 2 GROUPS:&#xD;
&#xD;
        -  control group: 153 patients received Oxytocin 10 IU I.V shot administered at the time of&#xD;
           delivery of the anterior shoulder of the baby according to the WHO recommendation for&#xD;
           both groups in prevention of postpartum haemorrhage,followed by active management of the&#xD;
           third stage of labor by administration of oxytocin 5 IU units IM (WHO GDG&#xD;
           recommendations,2012) and waiting for signs of placental separation then controlled cord&#xD;
           traction (CCT)to the umbilical cord while applying simultaneous counter-pressure to the&#xD;
           uterus, through the abdomen(Brandt Andrews maneuver)&#xD;
&#xD;
        -  study group:156 patients received Oxytocin 10 IU I.V shot at the time of delivery of the&#xD;
           of the anterior shoulder of the baby according to the WHO recommendation .Then oxytocin&#xD;
           is stopped and cervical traction (Amr maneuver )is applied.&#xD;
&#xD;
      In the maneuver,sustained traction downward and posteriorly was applied to anterior and&#xD;
      posterior lips of the cervix using ovum forceps for approximately 90 seconds. The traction&#xD;
      should be adequate to allow the cervix to reach the vaginal introitus. Meanwhile (CCT ) is&#xD;
      avoided and watchful waiting for signs of placental separartion till 90 seconds end. Massage&#xD;
      is not employed but the fundus is frequently palpaple to insure it doesnot become atonic and&#xD;
      filled with blood from placenta separation. In cases whom placental separation did not occur&#xD;
      within the 90 seconds, we removed the ovum forceps and waited for 30 min for the placental&#xD;
      separation .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 31, 2020</start_date>
  <completion_date type="Anticipated">September 2021</completion_date>
  <primary_completion_date type="Anticipated">August 2021</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>postpartum hemorrhage</measure>
    <time_frame>24 hours after delivery</time_frame>
    <description>blood loss more than 500 cc after delivery</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">306</enrollment>
  <condition>Post Partum Hemorrhage</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>153 patients received Oxytocin 10 IU I.V shot administered at the time of delivery of the anterior shoulder of the baby according to the WHO recommendation for both groups in prevention of postpartum haemorrhage,followed by active management of the third stage of labor by administration of oxytocin 5 IU units IM (WHO GDG recommendations,2012) and waiting for signs of placental separation then controlled cord traction (CCT)to the umbilical cord while applying simultaneous counter-pressure to the uterus, through the abdomen(Brandt Andrews maneuver)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>156 patients received Oxytocin 10 IU I.V shot at the time of delivery of the of the anterior shoulder of the baby according to the WHO recommendation .Then oxytocin is stopped and cervical traction (Amr maneuver )is applied.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxytocin IV shot</intervention_name>
    <description>Oxytocin 10 IU I.V shot administered at the time of delivery of the anterior shoulder of the baby</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Study group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxytocin IV drip</intervention_name>
    <description>administration of oxytocin 5 IU units IM (WHO GDG recommendations,2012) and waiting for signs of placental separation</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Amr maneuver</intervention_name>
    <description>sustained traction downward and posteriorly was applied to anterior and posterior lips of the cervix using ovum forceps for approximately 90 seconds</description>
    <arm_group_label>Study group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women who candidate for vaginal delivery at casualty department singleton fetus full&#xD;
             term pregnancy ( gestational age of more than 37 weeks).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  fetal macrosomia, any case with bleeding tendency e.g: haemorrhagic diseases cases&#xD;
             with risk of postpartum haemorrhage as: Peripartun hemorrhage ( placenta previa or&#xD;
             placental abruption), anemia or hypertension.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kasr Alainy medical school</name>
      <address>
        <city>Cairo</city>
        <zip>12151</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ahmed Maged, MD</last_name>
      <phone>01005227404</phone>
      <email>prof.ahmedmaged@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>February 5, 2021</last_update_submitted>
  <last_update_submitted_qc>February 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed M Maged, MD</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>Postpartum Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxytocin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04401839
org study id: 59
nct id: NCT04401839
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The patients were divided randomly in to 2 GROUPS:

        -  control group: 153 patients received Oxytocin 10 IU I.V shot administered at the time of
           delivery of the anterior shoulder of the baby according to the WHO recommendation for
           both groups in prevention of postpartum haemorrhage,followed by active management of the
           third stage of labor by administration of oxytocin 5 IU units IM (WHO GDG
           recommendations,2012) and waiting for signs of placental separation then controlled cord
           traction (CCT)to the umbilical cord while applying simultaneous counter-pressure to the
           uterus, through the abdomen(Brandt Andrews maneuver)

        -  study group:156 patients received Oxytocin 10 IU I.V shot at the time of delivery of the
           of the anterior shoulder of the baby according to the WHO recommendation .Then oxytocin
           is stopped and cervical traction (Amr maneuver )is applied.
The patients were divided randomly in to 2 GROUPS:

        -  control group: 153 patients received Oxytocin 10 IU I.V shot administered at the time of
           delivery of the anterior shoulder of the baby according to the WHO recommendation for
           both groups in prevention of postpartum haemorrhage,followed by active management of the
           third stage of labor by administration of oxytocin 5 IU units IM (WHO GDG
           recommendations,2012) and waiting for signs of placental separation then controlled cord
           traction (CCT)to the umbilical cord while applying simultaneous counter-pressure to the
           uterus, through the abdomen(Brandt Andrews maneuver)

        -  study group:156 patients received Oxytocin 10 IU I.V shot at the time of delivery of the
           of the anterior shoulder of the baby according to the WHO recommendation .Then oxytocin
           is stopped and cervical traction (Amr maneuver )is applied.

      In the maneuver,sustained traction downward and posteriorly was applied to anterior and
      posterior lips of the cervix using ovum forceps for approximately 90 seconds. The traction
      should be adequate to allow the cervix to reach the vaginal introitus. Meanwhile (CCT ) is
      avoided and watchful waiting for signs of placental separartion till 90 seconds end. Massage
      is not employed but the fundus is frequently palpaple to insure it doesnot become atonic and
      filled with blood from placenta separation. In cases whom placental separation did not occur
      within the 90 seconds, we removed the ovum forceps and waited for 30 min for the placental
      separation .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: postpartum hemorrhage
time frame: 24 hours after delivery
description: blood loss more than 500 cc after delivery
arm group label: Control group
arm group type: Active Comparator
description: 153 patients received Oxytocin 10 IU I.V shot administered at the time of delivery of the anterior shoulder of the baby according to the WHO recommendation for both groups in prevention of postpartum haemorrhage,followed by active management of the third stage of labor by administration of oxytocin 5 IU units IM (WHO GDG recommendations,2012) and waiting for signs of placental separation then controlled cord traction (CCT)to the umbilical cord while applying simultaneous counter-pressure to the uterus, through the abdomen(Brandt Andrews maneuver)
arm group label: Study group
arm group type: Active Comparator
description: 156 patients received Oxytocin 10 IU I.V shot at the time of delivery of the of the anterior shoulder of the baby according to the WHO recommendation .Then oxytocin is stopped and cervical traction (Amr maneuver )is applied.
intervention type: Drug
intervention name: Oxytocin IV shot
description: Oxytocin 10 IU I.V shot administered at the time of delivery of the anterior shoulder of the baby
arm group label: Control group
arm group label: Study group
intervention type: Drug
intervention name: Oxytocin IV drip
description: administration of oxytocin 5 IU units IM (WHO GDG recommendations,2012) and waiting for signs of placental separation
arm group label: Control group
intervention type: Procedure
intervention name: Amr maneuver
description: sustained traction downward and posteriorly was applied to anterior and posterior lips of the cervix using ovum forceps for approximately 90 seconds
arm group label: Study group
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed M Maged, MD
investigator title: professor
mesh term: Postpartum Hemorrhage
mesh term: Hemorrhage
mesh term: Oxytocin
sharing ipd: No