<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/NCT03237000</url>
  </required_header>
  <id_info>
    <org_study_id>7</org_study_id>
    <nct_id>NCT03237000</nct_id>
  </id_info>
  <brief_title>Effect of Administering Intravenous Magnesium Sulfate on Fetal Cardiotocography and Neonatal Outcome in Preeclamptic Patients</brief_title>
  <official_title>Effect of Administering Intravenous Magnesium Sulfate Heptahydrate (MgSO4•7H2O) on Fetal Cardiotocography and Neonatal Outcome in Preeclamptic Patients in 3rd Trimester of Pregnancy</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Admission CTG for 20 minutes Settings on a CTG machine was standardised to enable a&#xD;
      consistent approach of interpretation of traces. Paper speed of 3cm per minute will be&#xD;
      adopted. Maternal heart rate was recorded and noted on CTG. Following birth date, time and&#xD;
      mode of delivery will be labelled on CTG.&#xD;
&#xD;
      Magnesium sulphate was administered by continuous intravenous infusion according to our&#xD;
      hospital protocol as follows:&#xD;
&#xD;
        -  Loading dose: 4-6 gm of magnesium sulphate diluted in 100 mL of IV fluid administered&#xD;
           over 15-20 min.&#xD;
&#xD;
        -  Maintenance dose: 2 gm/hr in 100 mL of IV infusion to be continued for 24 hours after&#xD;
           delivery.&#xD;
&#xD;
      Another 20 minutes CTG strip will be performed 20 minutes after administration of IV loading&#xD;
      MgSO4, 7H2O and thus ensuring that MgSO4 has reached peak serum levels&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Admission CTG:&#xD;
&#xD;
      Admission CTG will be performed for 20 minutes&#xD;
&#xD;
      I-Settings:&#xD;
&#xD;
        1. Settings on a CTG machine will be standardised to enable a consistent approach of&#xD;
           interpretation of traces.&#xD;
&#xD;
        2. Paper speed of 3cm per minute will be adopted.&#xD;
&#xD;
        3. CTGs will be labelled with mother's name, hospital number.&#xD;
&#xD;
        4. Date and time settings on machines will be labelled at commencement of tracing.&#xD;
&#xD;
        5. Maternal heart rate will be recorded and noted on CTG.&#xD;
&#xD;
        6. Following birth date, time and mode of delivery will be labelled on CTG.&#xD;
&#xD;
      Magnesium Sulphate hepatahydrate administration:&#xD;
&#xD;
      Magnesium sulphate will be administered by continuous intravenous infusion according to our&#xD;
      hospital protocol as follows:&#xD;
&#xD;
        -  Loading dose: 4-6 gm of magnesium sulphate diluted in 100 mL of IV fluid administered&#xD;
           over 15-20 min.&#xD;
&#xD;
        -  Maintenance dose: 2 gm/hr in 100 mL of IV infusion to be continued for 24 hours after&#xD;
           delivery.&#xD;
&#xD;
        -  Magnesium toxicity was monitored by hourly assessment of:&#xD;
&#xD;
             1. Patellar reflexes should be present.&#xD;
&#xD;
             2. Respiratory rate not &lt; 16/min.&#xD;
&#xD;
             3. Urine output not &lt; 100ml / hr. Another 20 minutes CTG strip will be performed 20&#xD;
                minutes after administration of IV loading MgSO4, 7H2O and thus ensuring that MgSO4&#xD;
                has reached peak serum levels&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 1, 2017</start_date>
  <completion_date type="Anticipated">January 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>Phase 4</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>
    <intervention_model_description>Magnesium sulphate was administered by continuous intravenous infusion according to our hospital protocol as follows:&#xD;
Loading dose: 4-6 gm of magnesium sulphate diluted in 100 mL of IV fluid administered over 15-20 min.&#xD;
Maintenance dose: 2 gm/hr in 100 mL of IV infusion to be continued for 24 hours after delivery.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fetal heart rate tracing</measure>
    <time_frame>20 minutes after MgSO4 administration</time_frame>
    <description>Settings on a CTG machine is standardised to enable a consistent approach of interpretation of traces. Paper speed of 3cm per minute is adopted</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Preeclampsia</condition>
  <arm_group>
    <arm_group_label>MgSO4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Magnesium sulphate was administered by continuous intravenous infusion according to our hospital protocol as follows:&#xD;
Loading dose: 4-6 gm of magnesium sulphate diluted in 100 mL of IV fluid administered over 15-20 min.&#xD;
Maintenance dose: 2 gm/hr in 100 mL of IV infusion to be continued for 24 hours after delivery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MgSO4</intervention_name>
    <description>Magnesium sulphate was administered by continuous intravenous infusion according to our hospital protocol as follows:&#xD;
Loading dose: 4-6 gm of magnesium sulphate diluted in 100 mL of IV fluid administered over 15-20 min.&#xD;
Maintenance dose: 2 gm/hr in 100 mL of IV infusion to be continued for 24 hours after delivery.</description>
    <arm_group_label>MgSO4</arm_group_label>
    <other_name>Magnisium sulfate</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Pregnant Women in the third trimester.&#xD;
&#xD;
          2. Severely preeclamptic patients.&#xD;
&#xD;
          3. Singleton Pregnancy.&#xD;
&#xD;
          4. Patients with normal admission CTG&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Evidence of fetal anomalies on scan.&#xD;
&#xD;
          2. Concomitant maternal morbidities as diabetes, cardiac disease.&#xD;
&#xD;
          3. Patients contraindicated to take MgSo4 e.g.: advanced renal disease.&#xD;
&#xD;
          4. Abnormal admission CTG.&#xD;
&#xD;
          5. Morbid obesity.&#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_official>
    <last_name>Ahmed Maged, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>kasr Alainy medical school</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ahmed Maged, MD</last_name>
    <phone>01005227404</phone>
    <email>prof.ahmedmaged@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ahmed Ibrahim, MD</last_name>
    <email>gyndoctor77@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>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>July 31, 2017</last_update_submitted>
  <last_update_submitted_qc>July 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed Maged</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Preeclampsia</keyword>
  <keyword>MgSO4</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pre-Eclampsia</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/NCT03237000
org study id: 7
nct id: NCT03237000
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Admission CTG for 20 minutes Settings on a CTG machine was standardised to enable a
      consistent approach of interpretation of traces. Paper speed of 3cm per minute will be
      adopted. Maternal heart rate was recorded and noted on CTG. Following birth date, time and
      mode of delivery will be labelled on CTG.

      Magnesium sulphate was administered by continuous intravenous infusion according to our
      hospital protocol as follows:

        -  Loading dose: 4-6 gm of magnesium sulphate diluted in 100 mL of IV fluid administered
           over 15-20 min.

        -  Maintenance dose: 2 gm/hr in 100 mL of IV infusion to be continued for 24 hours after
           delivery.

      Another 20 minutes CTG strip will be performed 20 minutes after administration of IV loading
      MgSO4, 7H2O and thus ensuring that MgSO4 has reached peak serum levels
Admission CTG:

      Admission CTG will be performed for 20 minutes

      I-Settings:

        1. Settings on a CTG machine will be standardised to enable a consistent approach of
           interpretation of traces.

        2. Paper speed of 3cm per minute will be adopted.

        3. CTGs will be labelled with mother's name, hospital number.

        4. Date and time settings on machines will be labelled at commencement of tracing.

        5. Maternal heart rate will be recorded and noted on CTG.

        6. Following birth date, time and mode of delivery will be labelled on CTG.

      Magnesium Sulphate hepatahydrate administration:

      Magnesium sulphate will be administered by continuous intravenous infusion according to our
      hospital protocol as follows:

        -  Loading dose: 4-6 gm of magnesium sulphate diluted in 100 mL of IV fluid administered
           over 15-20 min.

        -  Maintenance dose: 2 gm/hr in 100 mL of IV infusion to be continued for 24 hours after
           delivery.

        -  Magnesium toxicity was monitored by hourly assessment of:

             1. Patellar reflexes should be present.

             2. Respiratory rate not < 16/min.

             3. Urine output not < 100ml / hr. Another 20 minutes CTG strip will be performed 20
                minutes after administration of IV loading MgSO4, 7H2O and thus ensuring that MgSO4
                has reached peak serum levels
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Magnesium sulphate was administered by continuous intravenous infusion according to our hospital protocol as follows:
Loading dose: 4-6 gm of magnesium sulphate diluted in 100 mL of IV fluid administered over 15-20 min.
Maintenance dose: 2 gm/hr in 100 mL of IV infusion to be continued for 24 hours after delivery.
primary purpose: Diagnostic
masking: None (Open Label)
measure: Fetal heart rate tracing
time frame: 20 minutes after MgSO4 administration
description: Settings on a CTG machine is standardised to enable a consistent approach of interpretation of traces. Paper speed of 3cm per minute is adopted
arm group label: MgSO4
arm group type: Experimental
description: Magnesium sulphate was administered by continuous intravenous infusion according to our hospital protocol as follows:
Loading dose: 4-6 gm of magnesium sulphate diluted in 100 mL of IV fluid administered over 15-20 min.
Maintenance dose: 2 gm/hr in 100 mL of IV infusion to be continued for 24 hours after delivery.
intervention type: Drug
intervention name: MgSO4
description: Magnesium sulphate was administered by continuous intravenous infusion according to our hospital protocol as follows:
Loading dose: 4-6 gm of magnesium sulphate diluted in 100 mL of IV fluid administered over 15-20 min.
Maintenance dose: 2 gm/hr in 100 mL of IV infusion to be continued for 24 hours after delivery.
arm group label: MgSO4
other name: Magnisium sulfate
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Ahmed Maged, MD
role: Principal Investigator
affiliation: kasr Alainy medical school
last name: Ahmed Maged, MD
phone: 01005227404
email: prof.ahmedmaged@gmail.com
last name: Ahmed Ibrahim, MD
email: gyndoctor77@gmail.com
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed Maged
investigator title: Professor
mesh term: Pre-Eclampsia