<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/NCT03252496</url>
  </required_header>
  <id_info>
    <org_study_id>R/17.06.79</org_study_id>
    <nct_id>NCT03252496</nct_id>
  </id_info>
  <brief_title>Combined Colloids And Crystalloids Versus Crystalloids in Women With Preeclampsia Undergoing Cesarean Delivery</brief_title>
  <official_title>Combined Colloids And Crystalloids Versus Crystalloids in Women With Preeclampsia Undergoing Cesarean Delivery Under Spinal Anesthesia: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</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>
      This study will compare between combination of colloids/crystalloids and crystalloids in&#xD;
      women with preeclampsia undergoing elective cesarean delivery under spinal anesthesia&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This randomized, controlled, double blind study will be conducted on women with preeclampsia&#xD;
      with singleton pregnancy undergoing elective cesarean delivery under spinal anesthesia.&#xD;
      Immediately, after spinal anesthesia administration, patients will receive either 250 mL&#xD;
      colloid over 5 minutes followed by 500 mL crystalloid over 55 minutes then 250 mL colloid&#xD;
      over 60 minutes (Combination group) or 250 mL crystalloid over 5 minutes followed by 500 mL&#xD;
      over 55 minutes then 250 mL over 60 minutes (Crystalloid group). The studied maternal&#xD;
      outcomes will be the urine output, ephedrine requirement, incidence of hypotension, inferior&#xD;
      vena cava diameters, nausea/vomiting and bradycardia. Neonatal Apgar scores will be recorded&#xD;
      at 1 and 5 minutes post-delivery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 19, 2017</start_date>
  <completion_date type="Actual">July 15, 2021</completion_date>
  <primary_completion_date type="Actual">July 15, 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>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total urine output at 2 hours post-spinal</measure>
    <time_frame>2 hours after intrathecal injection</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Urine output at 1 hour post-spinal</measure>
    <time_frame>1 hour after intrathecal injection</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of oliguria</measure>
    <time_frame>2 hours after intrathecal injection</time_frame>
    <description>Total urine output at 2 hours post-spinal &lt;60 mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total ephedrine dose</measure>
    <time_frame>Intraoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pre-delivery ephedrine dose</measure>
    <time_frame>From intrathecal injection until delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients requiring ephedrine</measure>
    <time_frame>Intraoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients requiring ephedrine pre-delivery</measure>
    <time_frame>From intrathecal injection until delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of nausea and/or vomiting</measure>
    <time_frame>Intraoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of bradycardia</measure>
    <time_frame>Intraoperative</time_frame>
    <description>Heart rate &lt;50 beats/minute</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum and minimum inferior vena cava diameters</measure>
    <time_frame>Baseline, at 5 minutes post-spinal, immediately after delivery of the fetus, and at 1 and 2 hours post-spinal</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inferior vena cava collapsibility index</measure>
    <time_frame>Baseline, at 5 minutes post-spinal, immediately after delivery of the fetus, and at 1 and 2 hours post-spinal</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal Apgar score</measure>
    <time_frame>At 1 and 5 minutes after delivery</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Pre-Eclampsia</condition>
  <condition>Cesarean Section</condition>
  <arm_group>
    <arm_group_label>Combination</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>250 mL colloid over 5 minutes followed by 500 mL crystalloid over 55 minutes then 250 mL colloid over 60 minutes. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 μg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine and intravenous syntocinon will be administered.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Crystalloid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>250 mL crystalloid over 5 minutes followed by 500 mL crystalloid over 55 minutes then 250 mL crystalloid over 60 minutes. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 μg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine and intravenous syntocinon will be administered.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Spinal Anesthesia</intervention_name>
    <description>Performed at the L3-L4 or L4-L5 interspace using 27- or 25-gauge spinal needle</description>
    <arm_group_label>Combination</arm_group_label>
    <arm_group_label>Crystalloid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intrathecal Bupivacaine</intervention_name>
    <description>Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space</description>
    <arm_group_label>Combination</arm_group_label>
    <arm_group_label>Crystalloid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intrathecal Fentanyl</intervention_name>
    <description>Fentanyl 15 μg will be administered in the subarachnoid space</description>
    <arm_group_label>Combination</arm_group_label>
    <arm_group_label>Crystalloid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cesarean Delivery</intervention_name>
    <description>Lower segment cesarean section using the Pfannenstiel incision</description>
    <arm_group_label>Combination</arm_group_label>
    <arm_group_label>Crystalloid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Ultrasound Assessment of the Inferior Vena Cava</intervention_name>
    <description>The inferior vena cava largest and smallest diameters will be measured proximal to the opening of the hepatic veins in the longitudinal axis with the M-mode using a 8-2 MHz curved array ultrasound probe placed longitudinally in the subcostal region</description>
    <arm_group_label>Combination</arm_group_label>
    <arm_group_label>Crystalloid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>250 mL Colloid over 5 minutes</intervention_name>
    <description>6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride (voluven®) 250 mL will be administered over 5 minutes starting immediately after intrathecal injection</description>
    <arm_group_label>Combination</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>250 mL Crystalloid over 5 minutes</intervention_name>
    <description>Ringer acetate 250 mL will be administered over 5 minutes starting immediately after intrathecal injection</description>
    <arm_group_label>Crystalloid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>500 mL Crystalloid over 55 minutes</intervention_name>
    <description>Ringer acetate 500 mL will be administered over 55 minutes following colloid or crystalloid administration</description>
    <arm_group_label>Combination</arm_group_label>
    <arm_group_label>Crystalloid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>250 mL Colloid over 60 minutes</intervention_name>
    <description>After 60 minutes of intrathecal injection, 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride (voluven®) 250 mL will be administered over 60 minutes</description>
    <arm_group_label>Combination</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>250 mL Crystalloid over 60 minutes</intervention_name>
    <description>After 60 minutes of intrathecal injection, Ringer acetate 250 mL will be administered over 60 minutes</description>
    <arm_group_label>Crystalloid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intravenous Ephedrine</intervention_name>
    <description>Intravenous ephedrine 3, 5, and 10 mg will be administered when Systolic blood pressure decreases below 120, 110, and 90 mmHg, respectively.</description>
    <arm_group_label>Combination</arm_group_label>
    <arm_group_label>Crystalloid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intravenous Syntocinon</intervention_name>
    <description>Immediately after delivery, syntocinon 10 IU will be added to the running crystalloid solution</description>
    <arm_group_label>Combination</arm_group_label>
    <arm_group_label>Crystalloid</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Preeclampsia: Blood Pressure ≥140/90 mmHg after 20 weeks' gestation and proteinuria&#xD;
             ≥300 mg/24 hours or 1+ on urine dipstick&#xD;
&#xD;
          -  Singleton pregnancy&#xD;
&#xD;
          -  Elective cesarean delivery under spinal anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Height &lt;150 cm&#xD;
&#xD;
          -  Weight &lt;60 kg&#xD;
&#xD;
          -  Body mass index ≥45 kg/m2&#xD;
&#xD;
          -  Women presenting in labor&#xD;
&#xD;
          -  Contraindications to spinal anesthesia (increased intracranial pressure or local skin&#xD;
             infection)&#xD;
&#xD;
          -  Diabetes mellitus, cardiovascular, cerebrovascular, or renal disease&#xD;
&#xD;
          -  Preoperative administration of intravenous hydralazine or magnesium sulphate&#xD;
&#xD;
          -  Hemoglobin &lt;10 gm/dL&#xD;
&#xD;
          -  International Normalized Ratio &gt;1.3&#xD;
&#xD;
          -  Platelet count &lt;100,000 /mm3&#xD;
&#xD;
          -  Preoperative serum creatinine &gt;1.1 mg/dL&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohamed M Tawfik, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mansoura University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Anesthesia, Mansoura University Hospitals</name>
      <address>
        <city>Mansoura</city>
        <state>Dakahlia</state>
        <zip>35511</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>September 3, 2021</last_update_submitted>
  <last_update_submitted_qc>September 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura University</investigator_affiliation>
    <investigator_full_name>Mohamed Mohamed Tawfik</investigator_full_name>
    <investigator_title>Lecturer, Department of anesthesia and surgical intensive care, Primary investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pre-Eclampsia</mesh_term>
    <mesh_term>Eclampsia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ephedrine</mesh_term>
    <mesh_term>Fentanyl</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
    <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/NCT03252496
org study id: R/17.06.79
nct id: NCT03252496
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will compare between combination of colloids/crystalloids and crystalloids in
      women with preeclampsia undergoing elective cesarean delivery under spinal anesthesia
This randomized, controlled, double blind study will be conducted on women with preeclampsia
      with singleton pregnancy undergoing elective cesarean delivery under spinal anesthesia.
      Immediately, after spinal anesthesia administration, patients will receive either 250 mL
      colloid over 5 minutes followed by 500 mL crystalloid over 55 minutes then 250 mL colloid
      over 60 minutes (Combination group) or 250 mL crystalloid over 5 minutes followed by 500 mL
      over 55 minutes then 250 mL over 60 minutes (Crystalloid group). The studied maternal
      outcomes will be the urine output, ephedrine requirement, incidence of hypotension, inferior
      vena cava diameters, nausea/vomiting and bradycardia. Neonatal Apgar scores will be recorded
      at 1 and 5 minutes post-delivery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Total urine output at 2 hours post-spinal
time frame: 2 hours after intrathecal injection
measure: Urine output at 1 hour post-spinal
time frame: 1 hour after intrathecal injection
measure: Incidence of oliguria
time frame: 2 hours after intrathecal injection
description: Total urine output at 2 hours post-spinal <60 mL
measure: Total ephedrine dose
time frame: Intraoperative
measure: Pre-delivery ephedrine dose
time frame: From intrathecal injection until delivery
measure: Number of patients requiring ephedrine
time frame: Intraoperative
measure: Number of patients requiring ephedrine pre-delivery
time frame: From intrathecal injection until delivery
measure: Incidence of nausea and/or vomiting
time frame: Intraoperative
measure: Incidence of bradycardia
time frame: Intraoperative
description: Heart rate <50 beats/minute
measure: Maximum and minimum inferior vena cava diameters
time frame: Baseline, at 5 minutes post-spinal, immediately after delivery of the fetus, and at 1 and 2 hours post-spinal
measure: Inferior vena cava collapsibility index
time frame: Baseline, at 5 minutes post-spinal, immediately after delivery of the fetus, and at 1 and 2 hours post-spinal
measure: Neonatal Apgar score
time frame: At 1 and 5 minutes after delivery
arm group label: Combination
arm group type: Experimental
description: 250 mL colloid over 5 minutes followed by 500 mL crystalloid over 55 minutes then 250 mL colloid over 60 minutes. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 μg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine and intravenous syntocinon will be administered.
arm group label: Crystalloid
arm group type: Active Comparator
description: 250 mL crystalloid over 5 minutes followed by 500 mL crystalloid over 55 minutes then 250 mL crystalloid over 60 minutes. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 μg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine and intravenous syntocinon will be administered.
intervention type: Procedure
intervention name: Spinal Anesthesia
description: Performed at the L3-L4 or L4-L5 interspace using 27- or 25-gauge spinal needle
arm group label: Combination
arm group label: Crystalloid
intervention type: Drug
intervention name: Intrathecal Bupivacaine
description: Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space
arm group label: Combination
arm group label: Crystalloid
intervention type: Drug
intervention name: Intrathecal Fentanyl
description: Fentanyl 15 μg will be administered in the subarachnoid space
arm group label: Combination
arm group label: Crystalloid
intervention type: Procedure
intervention name: Cesarean Delivery
description: Lower segment cesarean section using the Pfannenstiel incision
arm group label: Combination
arm group label: Crystalloid
intervention type: Radiation
intervention name: Ultrasound Assessment of the Inferior Vena Cava
description: The inferior vena cava largest and smallest diameters will be measured proximal to the opening of the hepatic veins in the longitudinal axis with the M-mode using a 8-2 MHz curved array ultrasound probe placed longitudinally in the subcostal region
arm group label: Combination
arm group label: Crystalloid
intervention type: Drug
intervention name: 250 mL Colloid over 5 minutes
description: 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride (voluven®) 250 mL will be administered over 5 minutes starting immediately after intrathecal injection
arm group label: Combination
intervention type: Drug
intervention name: 250 mL Crystalloid over 5 minutes
description: Ringer acetate 250 mL will be administered over 5 minutes starting immediately after intrathecal injection
arm group label: Crystalloid
intervention type: Drug
intervention name: 500 mL Crystalloid over 55 minutes
description: Ringer acetate 500 mL will be administered over 55 minutes following colloid or crystalloid administration
arm group label: Combination
arm group label: Crystalloid
intervention type: Drug
intervention name: 250 mL Colloid over 60 minutes
description: After 60 minutes of intrathecal injection, 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride (voluven®) 250 mL will be administered over 60 minutes
arm group label: Combination
intervention type: Drug
intervention name: 250 mL Crystalloid over 60 minutes
description: After 60 minutes of intrathecal injection, Ringer acetate 250 mL will be administered over 60 minutes
arm group label: Crystalloid
intervention type: Drug
intervention name: Intravenous Ephedrine
description: Intravenous ephedrine 3, 5, and 10 mg will be administered when Systolic blood pressure decreases below 120, 110, and 90 mmHg, respectively.
arm group label: Combination
arm group label: Crystalloid
intervention type: Drug
intervention name: Intravenous Syntocinon
description: Immediately after delivery, syntocinon 10 IU will be added to the running crystalloid solution
arm group label: Combination
arm group label: Crystalloid
criteria: 
gender: Female
minimum age: 19 Years
maximum age: 40 Years
healthy volunteers: No
last name: Mohamed M Tawfik, MD
role: Principal Investigator
affiliation: Mansoura University Hospital
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Mansoura University
investigator full name: Mohamed Mohamed Tawfik
investigator title: Lecturer, Department of anesthesia and surgical intensive care, Primary investigator
mesh term: Pre-Eclampsia
mesh term: Eclampsia
mesh term: Ephedrine
mesh term: Fentanyl
mesh term: Bupivacaine
mesh term: Oxytocin
sharing ipd: No