<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/NCT03002636</url>
  </required_header>
  <id_info>
    <org_study_id>IPMCH-anes</org_study_id>
    <nct_id>NCT03002636</nct_id>
  </id_info>
  <brief_title>Safety and Risk Assessment of Obese Parturient Underwent Cesarean Section(CS) Delivery Under Different Anesthesia Ways</brief_title>
  <official_title>Safety and Risk Assessment of Obese Parturient Underwent Cesarean Section(CS) Delivery Under General Anesthesia or Intraspinal Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>International Peace Maternity and Child Health Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fudan University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      900 parturient who underwent CS under general anesthesia(GA) , intraspinal anesthesia&#xD;
      included epidural anesthesia(EA) and combined spinal-epidural anesthesia(CSEA), which were&#xD;
      divided into 3 groups: Morbid Obesity group (n=300) with body mass index (BMI) &gt;40 kg/m2 ,&#xD;
      severe Obesity group (n=300) with 30 kg/m2≤BMI ≤40 kg/m2 and non-Obesity group(n=300) with&#xD;
      BMI&lt;30 kg/m2. Findings Between January 1, 2013 and September 30, 2016, a total of 1000 women&#xD;
      met inclusion criteria and 900 women received allocated intervention. All patients were&#xD;
      divided into three groups: Morbid Obesity group(n=300), Severe Obesity group(n=300) and&#xD;
      non-Obesity group(n=300) according to body mass index (BMI) &gt;40 kg/m2, 30 kg/m2≤BMI ≤40 kg/m2&#xD;
      and BMI&lt;30 kg/m2.900 patients completed the protocol and related data were analysed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      900 parturient who underwent CS under general anesthesia(GA) , intraspinal anesthesia&#xD;
      included epidural anesthesia(EA) and combined spinal-epidural anesthesia(CSEA), which were&#xD;
      divided into 3 groups&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patients numbers of obese parturient complications</measure>
    <time_frame>2 years</time_frame>
    <description>Patients numbers of emergency, fetal macrosomia, gestational diabetes mellitus (GMD), CS history, fetal distress, elderly parturient women(≥35 years), prenatal fever, arrhythmias, abnormalities of the heart, hypertension(pre-eclampsia), multiple pregnancy, precious child, amniotic fluid abnormality, amout of bleeding, neonate Apgar's Score(1min), Apgar's Score(5min), and patients numbers of EA, GA, PACU (Postanesthesia Care Unit ) and ICU (Intensive Care Unit) for duration of hospital stay and anesthesia puncture times with 5&gt;n≥3 and n≥5 in three groups included non-Obesity group, severe Obesity group and Morbid Obesity group were also recorded. In addition, we also recorded puncture patients numbers in sitting position for all groups.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">900</enrollment>
  <condition>Cesarean Section</condition>
  <arm_group>
    <arm_group_label>Morbid Obesity group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Morbid Obesity group(n=300)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>severe Obesity group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>severe Obesity group (n=300)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-Obesity group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>non-Obesity group(n=300)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>anesthesia</intervention_name>
    <description>Anesthesia : (1) General Anesthesia (GA)(2) Epidural Anesthesia (EA) (3) Combined Spinal-Epidural Anesthesia (CSEA)</description>
    <arm_group_label>Morbid Obesity group</arm_group_label>
    <arm_group_label>non-Obesity group</arm_group_label>
    <arm_group_label>severe Obesity group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with ASA Physical Status gradeΙΙ～ΙΙΙ.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  scoliosis, congenital heart disease, lung, liver, kidney diseases or increased&#xD;
             intracranial pressure (ICP)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>24 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yongtao Gao, MD</last_name>
    <role>Study Director</role>
    <affiliation>Shanghai Jiao Tong University School of Medicine</affiliation>
  </overall_official>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 26, 2016</study_first_posted>
  <last_update_submitted>December 21, 2016</last_update_submitted>
  <last_update_submitted_qc>December 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 26, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Jiao Tong University School of Medicine</investigator_affiliation>
    <investigator_full_name>Zeyong Yang</investigator_full_name>
    <investigator_title>International Peace Maternity and Child Health Hospital</investigator_title>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Anesthesia Complications</keyword>
  <keyword>Body Mass Index (BMI)</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</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/NCT03002636
org study id: IPMCH-anes
nct id: NCT03002636
lead sponsor: 
collaborator: 
has dmc: Yes
900 parturient who underwent CS under general anesthesia(GA) , intraspinal anesthesia
      included epidural anesthesia(EA) and combined spinal-epidural anesthesia(CSEA), which were
      divided into 3 groups: Morbid Obesity group (n=300) with body mass index (BMI) >40 kg/m2 ,
      severe Obesity group (n=300) with 30 kg/m2≤BMI ≤40 kg/m2 and non-Obesity group(n=300) with
      BMI<30 kg/m2. Findings Between January 1, 2013 and September 30, 2016, a total of 1000 women
      met inclusion criteria and 900 women received allocated intervention. All patients were
      divided into three groups: Morbid Obesity group(n=300), Severe Obesity group(n=300) and
      non-Obesity group(n=300) according to body mass index (BMI) >40 kg/m2, 30 kg/m2≤BMI ≤40 kg/m2
      and BMI<30 kg/m2.900 patients completed the protocol and related data were analysed.
900 parturient who underwent CS under general anesthesia(GA) , intraspinal anesthesia
      included epidural anesthesia(EA) and combined spinal-epidural anesthesia(CSEA), which were
      divided into 3 groups
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Patients numbers of obese parturient complications
time frame: 2 years
description: Patients numbers of emergency, fetal macrosomia, gestational diabetes mellitus (GMD), CS history, fetal distress, elderly parturient women(≥35 years), prenatal fever, arrhythmias, abnormalities of the heart, hypertension(pre-eclampsia), multiple pregnancy, precious child, amniotic fluid abnormality, amout of bleeding, neonate Apgar's Score(1min), Apgar's Score(5min), and patients numbers of EA, GA, PACU (Postanesthesia Care Unit ) and ICU (Intensive Care Unit) for duration of hospital stay and anesthesia puncture times with 5>n≥3 and n≥5 in three groups included non-Obesity group, severe Obesity group and Morbid Obesity group were also recorded. In addition, we also recorded puncture patients numbers in sitting position for all groups.
arm group label: Morbid Obesity group
arm group type: Experimental
description: Morbid Obesity group(n=300)
arm group label: severe Obesity group
arm group type: Experimental
description: severe Obesity group (n=300)
arm group label: non-Obesity group
arm group type: Other
description: non-Obesity group(n=300)
intervention type: Procedure
intervention name: anesthesia
description: Anesthesia : (1) General Anesthesia (GA)(2) Epidural Anesthesia (EA) (3) Combined Spinal-Epidural Anesthesia (CSEA)
arm group label: Morbid Obesity group
arm group label: non-Obesity group
arm group label: severe Obesity group
criteria: 
gender: Female
minimum age: 24 Years
maximum age: 35 Years
healthy volunteers: No
last name: Yongtao Gao, MD
role: Study Director
affiliation: Shanghai Jiao Tong University School of Medicine
responsible party type: Principal Investigator
investigator affiliation: Shanghai Jiao Tong University School of Medicine
investigator full name: Zeyong Yang
investigator title: International Peace Maternity and Child Health Hospital
mesh term: Anesthetics
sharing ipd: No