xml: <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/NCT06030063</url>
    </required_header>
    <id_info>
      <org_study_id>2000033638</org_study_id>
      <nct_id>NCT06030063</nct_id>
    </id_info>
    <brief_title>The Society for Obstetric Anesthesia and Perinatology Research Network General Anesthesia Registry</brief_title>
    <official_title>The Society for Obstetric Anesthesia and Perinatology Research Network General Anesthesia Registry</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Yale University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Yale 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>
        The SOAP registry is a prospective, multicenter, electronic registry. The goal is to&#xD;
        investigate the indications, mode of airway management, predisposing factors, and obstetric&#xD;
        and anesthetic outcomes of pregnant patients who receive general anesthesia for cesarean&#xD;
        delivery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a central repository with data from 25-40 participating SOAP institutions/hospitals.&#xD;
  &#xD;
        The primary and secondary aims of this study are as follows:&#xD;
  &#xD;
          1. To determine the institutional factors associated with rates of general anesthesia for&#xD;
             cesarean delivery&#xD;
  &#xD;
          2. To perform a descriptive analysis of characteristics of general anesthesia for cesarean&#xD;
             delivery cases&#xD;
  &#xD;
          3. To determine maternal and anesthetic predictors of difficult intubation&#xD;
  &#xD;
        Data will be collected from each participating SOAP institution. Institutional data will&#xD;
        include information on the characteristics of the institution such as maternal level of care,&#xD;
        numbers of lives birth, staffing models, etc. This data will be collected prior to subjects&#xD;
        being enrolled into the registry and again at the registry closure to look at intuitional&#xD;
        changes over time.&#xD;
  &#xD;
        Inclusion into the registry is based on the following criteria:&#xD;
  &#xD;
          1. Pregnant women who have had a general anesthetic for Cesarean delivery&#xD;
  &#xD;
          2. 15-55 years old&#xD;
  &#xD;
        The general anesthesia registry will collect data on subject demographics in a deidentified&#xD;
        manner, including characteristics of the birth and delivery, gestational age, maternal&#xD;
        morbidities, and anesthetic management.&#xD;
  &#xD;
        The granular detail requested in the registry database will help to better understand the&#xD;
        nuances of how and why decisions are made about proceeding with general anesthesia in these&#xD;
        cases, and once done, how to implement this clinical course. As not all of these data points&#xD;
        are routinely recorded in the medical record, optimal data capture requires the treating&#xD;
        anesthesiologist to complete the registry entry as soon as possible after conclusion of&#xD;
        patient care.&#xD;
  &#xD;
        Data will be collected for approximately 5 years and maintained indefinitely. Data is entered&#xD;
        into a Yale REDCap registry and will not contain subject identifiers. An estimated 5000&#xD;
        subjects will be enrolled into the data repository. This is based on a published report of 45&#xD;
        institutions' data investigating a subtopic of this question (15 years yielding 15,000&#xD;
        general anesthetics).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2029</completion_date>
    <primary_completion_date type="Anticipated">September 2028</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Ecologic or Community</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Rates of General Anesthesia for Cesarean Delivery</measure>
      <time_frame>Up to 5 years</time_frame>
      <description>The rates of general anesthesia for cesarean delivery among the institutions in the cohort will be assessed. Descriptive analyses of etiologies of and management of general anesthetics for cesarean delivery will also be performed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Univariate Association Between Facility Type and the Rate of General Anesthesia for Cesarean Delivery</measure>
      <time_frame>Up to 5 years</time_frame>
      <description>The association between facility type- non-academic affiliated private vs. academic affiliated private vs. military vs. academic (reference)- with a difference in rates of general anesthesia for cesarean delivery will be assessed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Univariate Association Between SOAP Center of Excellence Designation and the Rate of General Anesthesia for Cesarean Delivery</measure>
      <time_frame>Up to 5 years</time_frame>
      <description>The association between SOAP center of excellence designation- yes (reference) vs. no- with a difference in rates of general anesthesia for cesarean delivery will be assessed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Univariate Association Between Maternal Level of Care and the Rate of General Anesthesia for Cesarean Association</measure>
      <time_frame>Up to 5 years</time_frame>
      <description>The association between maternal level of care- I vs. II vs. III vs. IV (reference)- with a difference in rates of general anesthesia for cesarean delivery will be assessed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Univariate Association Between Annual Live Births and the Rate of General Anesthesia for Cesarean Delivery</measure>
      <time_frame>Up to 5 years</time_frame>
      <description>The association between increased numbers of annual live births (continuous variable) and a difference in rates of general anesthesia for cesarean delivery will be assessed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Univariate Association Between Obstetric Anesthesiologist Coverage and the Rate of General Anesthesia for Cesarean Delivery</measure>
      <time_frame>Up to 5 years</time_frame>
      <description>The association between increased rates of labor and delivery floor coverage by obstetric anesthesiologists (continuous variable) and a difference in rates of general anesthesia for cesarean delivery will be assessed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Univariate Association Between Institutional Policies for Labor Epidural Management and the Rate of General Anesthesia for Cesarean Delivery</measure>
      <time_frame>Up to 5 years</time_frame>
      <description>The association between the presence of institutional policies for labor epidural management- yes (reference) vs. no- and a difference in rates of general anesthesia for cesarean delivery will be assessed.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Rates of Difficult Intubation Among Women Undergoing General Anesthesia for Cesarean Delivery</measure>
      <time_frame>Up to 5 years</time_frame>
      <description>Among the cohort of general anesthetics for cesarean delivery, the incidence of difficult intubation will be determined.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Univariate Association Between Mallampati Score and the Risk of Difficult Intubation</measure>
      <time_frame>Up to 5 years</time_frame>
      <description>The association between increased Mallampati score- I or II (reference) vs. III vs. IV- and a difference in risk of difficult intubation will be assessed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Univariate Association Between Neck Mobility and the Risk of Difficult Intubation</measure>
      <time_frame>Up to 5 years</time_frame>
      <description>The association between neck mobility- full (reference) vs. limited vs. poor and a difference in risk of difficult intubation will be assessed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Univariate Association Between Neck Circumference and the Risk of Difficult Intubation</measure>
      <time_frame>Up to 5 years</time_frame>
      <description>The association between neck circumference- thin or average (reference) vs. thick and a difference in risk of difficult intubation will be assessed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Univariate Association Between Neck Length and the Risk of Difficult Intubation</measure>
      <time_frame>Up to 5 years</time_frame>
      <description>The association between neck length- long or average (reference) vs. short and a difference in risk of difficult intubation will be assessed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Univariate Association Between Thyromental Distance and the Risk of Difficult Intubation</measure>
      <time_frame>Up to 5 years</time_frame>
      <description>The association between thyromental distance- &gt;6.5cm (reference) vs. 3.5-6.5cm vs. &lt;3.5cm and a difference in risk of difficult intubation will be assessed.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">5000</enrollment>
    <condition>Cesarean Delivery</condition>
    <condition>General Anesthesia</condition>
    <eligibility>
      <study_pop>
        <textblock>
          The subject population will reflect the diverse populations of the participating hospitals.&#xD;
          The subject population will include pregnant women aged 15-55 years old who have a general&#xD;
          anesthetic during their cesarean delivery. Non-English-speaking subjects will be included.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          -Pregnant women aged 15-55 who have had a general anesthetic for Cesarean delivery&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Lisa Leffert, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Yale Univesrity</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lisa Leffert, MD</last_name>
      <phone>(203)785-4304</phone>
      <email>lisa.leffert@yale.edu</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06030063
  org study id: 2000033638
  nct id: NCT06030063
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The SOAP registry is a prospective, multicenter, electronic registry. The goal is to
        investigate the indications, mode of airway management, predisposing factors, and obstetric
        and anesthetic outcomes of pregnant patients who receive general anesthesia for cesarean
        delivery.
  This is a central repository with data from 25-40 participating SOAP institutions/hospitals.
  
        The primary and secondary aims of this study are as follows:
  
          1. To determine the institutional factors associated with rates of general anesthesia for
             cesarean delivery
  
          2. To perform a descriptive analysis of characteristics of general anesthesia for cesarean
             delivery cases
  
          3. To determine maternal and anesthetic predictors of difficult intubation
  
        Data will be collected from each participating SOAP institution. Institutional data will
        include information on the characteristics of the institution such as maternal level of care,
        numbers of lives birth, staffing models, etc. This data will be collected prior to subjects
        being enrolled into the registry and again at the registry closure to look at intuitional
        changes over time.
  
        Inclusion into the registry is based on the following criteria:
  
          1. Pregnant women who have had a general anesthetic for Cesarean delivery
  
          2. 15-55 years old
  
        The general anesthesia registry will collect data on subject demographics in a deidentified
        manner, including characteristics of the birth and delivery, gestational age, maternal
        morbidities, and anesthetic management.
  
        The granular detail requested in the registry database will help to better understand the
        nuances of how and why decisions are made about proceeding with general anesthesia in these
        cases, and once done, how to implement this clinical course. As not all of these data points
        are routinely recorded in the medical record, optimal data capture requires the treating
        anesthesiologist to complete the registry entry as soon as possible after conclusion of
        patient care.
  
        Data will be collected for approximately 5 years and maintained indefinitely. Data is entered
        into a Yale REDCap registry and will not contain subject identifiers. An estimated 5000
        subjects will be enrolled into the data repository. This is based on a published report of 45
        institutions' data investigating a subtopic of this question (15 years yielding 15,000
        general anesthetics).
  observational model: Ecologic or Community
  time perspective: Retrospective
  measure: Rates of General Anesthesia for Cesarean Delivery
  time frame: Up to 5 years
  description: The rates of general anesthesia for cesarean delivery among the institutions in the cohort will be assessed. Descriptive analyses of etiologies of and management of general anesthetics for cesarean delivery will also be performed.
  measure: Univariate Association Between Facility Type and the Rate of General Anesthesia for Cesarean Delivery
  time frame: Up to 5 years
  description: The association between facility type- non-academic affiliated private vs. academic affiliated private vs. military vs. academic (reference)- with a difference in rates of general anesthesia for cesarean delivery will be assessed.
  measure: Univariate Association Between SOAP Center of Excellence Designation and the Rate of General Anesthesia for Cesarean Delivery
  time frame: Up to 5 years
  description: The association between SOAP center of excellence designation- yes (reference) vs. no- with a difference in rates of general anesthesia for cesarean delivery will be assessed.
  measure: Univariate Association Between Maternal Level of Care and the Rate of General Anesthesia for Cesarean Association
  time frame: Up to 5 years
  description: The association between maternal level of care- I vs. II vs. III vs. IV (reference)- with a difference in rates of general anesthesia for cesarean delivery will be assessed.
  measure: Univariate Association Between Annual Live Births and the Rate of General Anesthesia for Cesarean Delivery
  time frame: Up to 5 years
  description: The association between increased numbers of annual live births (continuous variable) and a difference in rates of general anesthesia for cesarean delivery will be assessed.
  measure: Univariate Association Between Obstetric Anesthesiologist Coverage and the Rate of General Anesthesia for Cesarean Delivery
  time frame: Up to 5 years
  description: The association between increased rates of labor and delivery floor coverage by obstetric anesthesiologists (continuous variable) and a difference in rates of general anesthesia for cesarean delivery will be assessed.
  measure: Univariate Association Between Institutional Policies for Labor Epidural Management and the Rate of General Anesthesia for Cesarean Delivery
  time frame: Up to 5 years
  description: The association between the presence of institutional policies for labor epidural management- yes (reference) vs. no- and a difference in rates of general anesthesia for cesarean delivery will be assessed.
  measure: Rates of Difficult Intubation Among Women Undergoing General Anesthesia for Cesarean Delivery
  time frame: Up to 5 years
  description: Among the cohort of general anesthetics for cesarean delivery, the incidence of difficult intubation will be determined.
  measure: Univariate Association Between Mallampati Score and the Risk of Difficult Intubation
  time frame: Up to 5 years
  description: The association between increased Mallampati score- I or II (reference) vs. III vs. IV- and a difference in risk of difficult intubation will be assessed.
  measure: Univariate Association Between Neck Mobility and the Risk of Difficult Intubation
  time frame: Up to 5 years
  description: The association between neck mobility- full (reference) vs. limited vs. poor and a difference in risk of difficult intubation will be assessed.
  measure: Univariate Association Between Neck Circumference and the Risk of Difficult Intubation
  time frame: Up to 5 years
  description: The association between neck circumference- thin or average (reference) vs. thick and a difference in risk of difficult intubation will be assessed.
  measure: Univariate Association Between Neck Length and the Risk of Difficult Intubation
  time frame: Up to 5 years
  description: The association between neck length- long or average (reference) vs. short and a difference in risk of difficult intubation will be assessed.
  measure: Univariate Association Between Thyromental Distance and the Risk of Difficult Intubation
  time frame: Up to 5 years
  description: The association between thyromental distance- >6.5cm (reference) vs. 3.5-6.5cm vs. <3.5cm and a difference in risk of difficult intubation will be assessed.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 15 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Lisa Leffert, MD
  role: Principal Investigator
  affiliation: Yale Univesrity
  last name: Lisa Leffert, MD
  phone: (203)785-4304
  email: lisa.leffert@yale.edu
  responsible party type: Sponsor