<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/NCT03018119</url>
  </required_header>
  <id_info>
    <org_study_id>2015P002403</org_study_id>
    <nct_id>NCT03018119</nct_id>
  </id_info>
  <brief_title>Implementation of the NPMS Obstetric Hemorrhage Bundle at a Tertiary Center: Utilization of the Delphi Method</brief_title>
  <official_title>Implementation of the National Partnership for Maternal Safety Obstetric Hemorrhage Bundle at a Tertiary Center: Utilization of the Delphi Method</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brigham and Women's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The National Partnership for Maternal Safety (NPMS) developed an obstetric hemorrhage&#xD;
      consensus bundle to provide every United States birthing facility consistent, validated&#xD;
      practice guidelines. To facilitate implementation of each element of this bundle at the&#xD;
      participants large tertiary center, the investigators utilized the Delphi method to identify&#xD;
      deficiencies, perceived barriers to implementation, and multidisciplinary consensus on&#xD;
      changes with high feasibility and impact on patient care.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2015</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">April 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Questionnaire of Obstetric Hemorrhage Bundle Components not Currently Adequately Implemented</measure>
    <time_frame>4 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Questionnaire of Perceived Barriers to Implementation of Obstetric Hemorrhage Bundle Components</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire of Feasibility of Implementation of Obstetric Hemorrhage Bundle Components</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire on Impact of Implementation of Obstetric Hemorrhage Bundle Components on Patient Care</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Pregnancy Hemorrhage</condition>
  <condition>Postpartum Hemorrhage</condition>
  <arm_group>
    <arm_group_label>Anesthesiologists</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Total: 11 Intervention: Survey</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Obstetricians</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Total: 11 Intervention: Survey</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Registered Nurses</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Total: 10 Intervention: Survey</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Surgical Technicians</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Total: 6 Intervention: Survey</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey</intervention_name>
    <arm_group_label>Anesthesiologists</arm_group_label>
    <arm_group_label>Obstetricians</arm_group_label>
    <arm_group_label>Registered Nurses</arm_group_label>
    <arm_group_label>Surgical Technicians</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥ five years of experience on the L&amp;D unit&#xD;
&#xD;
          -  current employment on the L&amp;D unit &gt; 20h per week&#xD;
&#xD;
          -  prior involvement in clinical obstetric hemorrhage situations&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michaela Farber, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brigham and Women's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Main EK, Goffman D, Scavone BM, Low LK, Bingham D, Fontaine PL, Gorlin JB, Lagrew DC, Levy BS. National Partnership for Maternal Safety: consensus bundle on obstetric hemorrhage. Anesth Analg. 2015 Jul;121(1):142-148. doi: 10.1097/AOG.0000000000000869. Erratum In: Anesth Analg. 2019 Dec;129(6):e206.</citation>
    <PMID>26091046</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>January 10, 2017</last_update_submitted>
  <last_update_submitted_qc>January 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
    <investigator_full_name>Annemaria De Tina</investigator_full_name>
    <investigator_title>Clinical Fellow - Obstetric Anesthesia</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postpartum Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_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/NCT03018119
org study id: 2015P002403
nct id: NCT03018119
lead sponsor: 
has dmc: Yes
The National Partnership for Maternal Safety (NPMS) developed an obstetric hemorrhage
      consensus bundle to provide every United States birthing facility consistent, validated
      practice guidelines. To facilitate implementation of each element of this bundle at the
      participants large tertiary center, the investigators utilized the Delphi method to identify
      deficiencies, perceived barriers to implementation, and multidisciplinary consensus on
      changes with high feasibility and impact on patient care.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Questionnaire of Obstetric Hemorrhage Bundle Components not Currently Adequately Implemented
time frame: 4 weeks
measure: Questionnaire of Perceived Barriers to Implementation of Obstetric Hemorrhage Bundle Components
time frame: 4 weeks
measure: Questionnaire of Feasibility of Implementation of Obstetric Hemorrhage Bundle Components
time frame: 6 months
measure: Questionnaire on Impact of Implementation of Obstetric Hemorrhage Bundle Components on Patient Care
time frame: 6 months
arm group label: Anesthesiologists
arm group type: Active Comparator
description: Total: 11 Intervention: Survey
arm group label: Obstetricians
arm group type: Active Comparator
description: Total: 11 Intervention: Survey
arm group label: Registered Nurses
arm group type: Active Comparator
description: Total: 10 Intervention: Survey
arm group label: Surgical Technicians
arm group type: Active Comparator
description: Total: 6 Intervention: Survey
intervention type: Other
intervention name: Survey
arm group label: Anesthesiologists
arm group label: Obstetricians
arm group label: Registered Nurses
arm group label: Surgical Technicians
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Michaela Farber, MD, MS
role: Principal Investigator
affiliation: Brigham and Women's Hospital
facility: 
country: United States
citation: Main EK, Goffman D, Scavone BM, Low LK, Bingham D, Fontaine PL, Gorlin JB, Lagrew DC, Levy BS. National Partnership for Maternal Safety: consensus bundle on obstetric hemorrhage. Anesth Analg. 2015 Jul;121(1):142-148. doi: 10.1097/AOG.0000000000000869. Erratum In: Anesth Analg. 2019 Dec;129(6):e206.
PMID: 26091046
responsible party type: Principal Investigator
investigator affiliation: Brigham and Women's Hospital
investigator full name: Annemaria De Tina
investigator title: Clinical Fellow - Obstetric Anesthesia
mesh term: Postpartum Hemorrhage
mesh term: Hemorrhage
sharing ipd: No