<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/NCT04401852</url>
  </required_header>
  <id_info>
    <org_study_id>60</org_study_id>
    <nct_id>NCT04401852</nct_id>
  </id_info>
  <brief_title>Magnesium Sulfate for Fetal Neuroprotection</brief_title>
  <official_title>Magnesium Sulphate for Fetal Neuroprotection in Full Term Deliveries</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>
      Pregnant women diagnosed to have intrapartum fetal distress (Non reassuring or pathological&#xD;
      changes according to NICE guidelines 2017) in any of the groups will receive the allocated&#xD;
      treatment at least 20 minute before the procedure (emergency CS).&#xD;
&#xD;
      measures to reduce the effect of hypoxia will be applied to all participate through:&#xD;
&#xD;
        -  The position of the mother will be changed to left lateral position (allow increased&#xD;
           blood supply).&#xD;
&#xD;
        -  I.V. fluid bolus (to avoid maternal dehydration).&#xD;
&#xD;
        -  Oxytocin or cervical ripening agent will be discontinued.&#xD;
&#xD;
        -  Fetal heart rate monitoring with cardiotocography will be attempted.&#xD;
&#xD;
        -  If umbilical cord prolapse is noted, elevate the presenting fetal part until preparing&#xD;
           for emergency operative delivery.&#xD;
&#xD;
        -  After birth, Apgar score will be used to identify distress newborns that need&#xD;
           resuscitation.&#xD;
&#xD;
      The study comprised 200 pregnant women. They were divided into two groups each are 100:&#xD;
&#xD;
        -  Group A: pregnant women diagnosed to have intrapartum fetal distress who will receive&#xD;
           MgSO4.&#xD;
&#xD;
        -  Group B: pregnant women diagnosed to have intrapartum fetal distress who will receive&#xD;
           placebo&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pregnant women diagnosed to have intrapartum fetal distress (Non reassuring or pathological&#xD;
      changes according to NICE guidelines 2017) in any of the groups will receive the allocated&#xD;
      treatment at least 20 minute before the procedure (emergency CS).&#xD;
&#xD;
      measures to reduce the effect of hypoxia will be applied to all participate through:&#xD;
&#xD;
        -  The position of the mother will be changed to left lateral position (allow increased&#xD;
           blood supply).&#xD;
&#xD;
        -  I.V. fluid bolus (to avoid maternal dehydration).&#xD;
&#xD;
        -  Oxytocin or cervical ripening agent will be discontinued.&#xD;
&#xD;
        -  Fetal heart rate monitoring with cardiotocography will be attempted.&#xD;
&#xD;
        -  If umbilical cord prolapse is noted, elevate the presenting fetal part until preparing&#xD;
           for emergency operative delivery.&#xD;
&#xD;
        -  After birth, Apgar score will be used to identify distress newborns that need&#xD;
           resuscitation.&#xD;
&#xD;
      The study comprised 200 pregnant women. They were divided into two groups each are 100:&#xD;
&#xD;
        -  Group A: pregnant women diagnosed to have intrapartum fetal distress who will receive&#xD;
           MgSO4.&#xD;
&#xD;
        -  Group B: pregnant women diagnosed to have intrapartum fetal distress who will receive&#xD;
           placebo&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 21, 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Apgar score</measure>
    <time_frame>1 minute after delivery</time_frame>
    <description>Apgar stands for &quot;Appearance, Pulse, Grimace, Activity, and Respiration between 0 and 10</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Fetal Neuroprotection</condition>
  <arm_group>
    <arm_group_label>MgSO4 group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>will receive a single bolus dose of 4g MgSO4 slowly intravenous over 15-20 minutes without maintenance dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>will receive an equal volume of isotonic 0.9% saline over 15-20 minutes</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MgSo4</intervention_name>
    <description>a single bolus dose of 4g MgSO4 slowly intravenous over 15-20 minutes without maintenance dose.</description>
    <arm_group_label>MgSO4 group</arm_group_label>
    <other_name>magnesium sulfate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Isotonic saline</intervention_name>
    <description>equal volume of isotonic 0.9% saline over 15-20 minutes</description>
    <arm_group_label>placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women at least 37 week of gestation.&#xD;
&#xD;
          -  Not more than 35 years old.&#xD;
&#xD;
          -  Fetal distress (perinatal asphyxia) diagnosed by CTG changes (Non reassuring or&#xD;
             pathological changes according to NICE guidelines 2017).&#xD;
&#xD;
          -  Clinical chorioamnionitis.&#xD;
&#xD;
          -  Prolonged rupture of membranes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical disorders such as chronic hypertension, preeclampsia, eclampsia, DM, pulmonary&#xD;
             hypertension, hepatic coma with risk of renal failure, and any renal, cardiac or&#xD;
             pulmonary disease.&#xD;
&#xD;
          -  RH -ve.&#xD;
&#xD;
          -  Consanguinity.&#xD;
&#xD;
          -  Preterm labor.&#xD;
&#xD;
          -  Fetal malpresentation.&#xD;
&#xD;
          -  Contraindications to the use of Magnesium Sulphate.&#xD;
&#xD;
          -  Any indication for magnesium Sulphate therapy (seizure prophylaxis or tocolysis).&#xD;
&#xD;
          -  Myasthenia gravis.&#xD;
&#xD;
          -  Congenital fetal anomalies.&#xD;
&#xD;
          -  Fetal growth restriction (birth weight &lt; 10th Percentile for gestational age).&#xD;
&#xD;
          -  Advanced cervical dilation (8cm).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ahmed maged</last_name>
    <phone>+201005227404</phone>
    <email>ahmedmaged@cu.edu.eg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Wesam Deeb</last_name>
    <email>wessamdeeb74@gmail.com</email>
  </overall_contact_backup>
  <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 22, 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 9, 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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Magnesium Sulfate</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/NCT04401852
org study id: 60
nct id: NCT04401852
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Pregnant women diagnosed to have intrapartum fetal distress (Non reassuring or pathological
      changes according to NICE guidelines 2017) in any of the groups will receive the allocated
      treatment at least 20 minute before the procedure (emergency CS).

      measures to reduce the effect of hypoxia will be applied to all participate through:

        -  The position of the mother will be changed to left lateral position (allow increased
           blood supply).

        -  I.V. fluid bolus (to avoid maternal dehydration).

        -  Oxytocin or cervical ripening agent will be discontinued.

        -  Fetal heart rate monitoring with cardiotocography will be attempted.

        -  If umbilical cord prolapse is noted, elevate the presenting fetal part until preparing
           for emergency operative delivery.

        -  After birth, Apgar score will be used to identify distress newborns that need
           resuscitation.

      The study comprised 200 pregnant women. They were divided into two groups each are 100:

        -  Group A: pregnant women diagnosed to have intrapartum fetal distress who will receive
           MgSO4.

        -  Group B: pregnant women diagnosed to have intrapartum fetal distress who will receive
           placebo
Pregnant women diagnosed to have intrapartum fetal distress (Non reassuring or pathological
      changes according to NICE guidelines 2017) in any of the groups will receive the allocated
      treatment at least 20 minute before the procedure (emergency CS).

      measures to reduce the effect of hypoxia will be applied to all participate through:

        -  The position of the mother will be changed to left lateral position (allow increased
           blood supply).

        -  I.V. fluid bolus (to avoid maternal dehydration).

        -  Oxytocin or cervical ripening agent will be discontinued.

        -  Fetal heart rate monitoring with cardiotocography will be attempted.

        -  If umbilical cord prolapse is noted, elevate the presenting fetal part until preparing
           for emergency operative delivery.

        -  After birth, Apgar score will be used to identify distress newborns that need
           resuscitation.

      The study comprised 200 pregnant women. They were divided into two groups each are 100:

        -  Group A: pregnant women diagnosed to have intrapartum fetal distress who will receive
           MgSO4.

        -  Group B: pregnant women diagnosed to have intrapartum fetal distress who will receive
           placebo
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Apgar score
time frame: 1 minute after delivery
description: Apgar stands for "Appearance, Pulse, Grimace, Activity, and Respiration between 0 and 10
arm group label: MgSO4 group
arm group type: Active Comparator
description: will receive a single bolus dose of 4g MgSO4 slowly intravenous over 15-20 minutes without maintenance dose
arm group label: placebo group
arm group type: Placebo Comparator
description: will receive an equal volume of isotonic 0.9% saline over 15-20 minutes
intervention type: Drug
intervention name: MgSo4
description: a single bolus dose of 4g MgSO4 slowly intravenous over 15-20 minutes without maintenance dose.
arm group label: MgSO4 group
other name: magnesium sulfate
intervention type: Drug
intervention name: Isotonic saline
description: equal volume of isotonic 0.9% saline over 15-20 minutes
arm group label: placebo group
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Ahmed maged
phone: +201005227404
email: ahmedmaged@cu.edu.eg
last name: Wesam Deeb
email: wessamdeeb74@gmail.com
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: Magnesium Sulfate
sharing ipd: No